## Protocol Section
### Identification Module
**NCT ID:** NCT02170779

**Brief Title:** Developing and Testing a Comprehensive MS Spasticity Management Program

**Official Title:** Developing and Testing a Comprehensive MS Spasticity Management Program

#### Organization Study ID Info
**ID:** N1401-P
#### Organization
**Class:** FED
**Full Name:** VA Office of Research and Development
### Status Module
#### Completion Date
**Date:** 2016-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-03-28

**Type:** ACTUAL

**Last Update Submit Date:** 2017-02-07

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-05

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-03-28

**Type:** ACTUAL

**Results First Submit Date:** 2016-12-12

**Results First Submit QC Date:** 2017-02-07

#### Start Date
**Date:** 2015-10

**Status Verified Date:** 2017-02

#### Study First Post Date
**Date:** 2014-06-23
**Type:** ESTIMATED
**Study First Submit Date:** 2014-06-09
**Study First Submit QC Date:** 2014-06-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Oregon Health and Science University

#### Lead Sponsor

**Class:** FED

**Name:** VA Office of Research and Development

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This is a study to determine the impact of education and specific lower extremity stretches for MS-related spasticity. The study will evaluate the acceptance and efficacy of education and stretching using a randomized controlled pilot trial.

**Detailed Description:** Participants have 2-4 visits depending on program assignment. All participants will have screening/baseline and follow-up visits. Participants in the intervention program will have 2 additional visits with a group of other people with MS to view and discuss the DVDs on spasticity education and stretching for lower extremity MS spasticity and then practice the stretching exercises learned. They will be asked to track exercise electronically and on paper for 4 weeks. Participants will be compensated for participation.

### Conditions Module

**Conditions:**

- Multiple Sclerosis

- Spasticity

**Keywords:**

- multiple sclerosis

- spasticity

- stretching

- exercise

- rehabilitation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures

**Intervention Names:**

- Behavioral: Spasticity: Take Control

**Label:** A Spasticity: Take Control

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures

**Intervention Names:**

- Other: Usual care

**Label:** B Usual care

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- A Spasticity: Take Control

**Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures

**Name:** Spasticity: Take Control

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- B Usual care

**Description:** 2 visits: baseline followed by usual care of brochure for stretching then outcome measures

**Name:** Usual care

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The MSWS-12 is a clinically validated and reliable tool that is flexible and simple enough to use clinically and in research. It captures patients' perspectives on their ambulatory disability on the following: standing, ability to run, need for support, moving around the home, concentration needed to walk, walking speed, maintaining balance, climbing stairs, walking distance, effort needed to walk, ability to walk, and gait. It is simple to administer and responsive to changes in patient performance over time.

Individual items are scored on a 5 point Likert scale: 1 (Not at all), 2 (A little), 3 (Moderately), 4 (Quite a bit), 5 (Extremely). A total score is generated and reported on a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12, or 48), and multiplying. Higher values represent a worse outcome and greater disability.

**Measure:** MS Walking Scale-12 (MSWS-12)

**Time Frame:** at average of 4 months

#### Secondary Outcomes

**Description:** The time to walk 25 feet is strongly related to its ordinal counterpart the Ambulation Index (Spearman r=0.91) without the variability the ordinal scale reflects.

The time is measured and recorded in seconds how long it takes for the participant to walk 25 feet.

**Measure:** Timed 25 Foot Walk

**Time Frame:** at average of 4 months

**Description:** The Timed Up and Go (TUG) test measures the time in seconds it takes to get up from a chair, walk 10 feet, turn around and return to sit in the chair.

The best score of the two attempts was analyzed.

**Measure:** Timed up and go Test

**Time Frame:** at average of 4 months

**Description:** The subject walks without assistance of another person for 2 minutes. The distance in feet the individual was able to walk in 2 minutes is then measured.

**Measure:** 2 Minute Walk Test

**Time Frame:** at average of 4 months

**Description:** This self-report retrospective questionnaire measures fatigue symptoms. It consists of 21 items scored 0-4 for a total score between 0 and 84 and has a coefficient alpha of 0.81. Lower scores on the MFIS indicate less fatigue.

**Measure:** Modified Fatigue Impact Scale (MFIS)

**Time Frame:** at average of 4 months

**Description:** The MSIS-29 is designed to measure the physical and psychological impact of MS.

Each subscale summed separately. No total calculated. Scores transformed to have a range of 0-100. Lower scores indicate less impact, higher scores indicate higher impact.

**Measure:** Multiple Sclerosis Impact Scale (MSIS-29)

**Time Frame:** at average of 4 months

**Description:** The modified Ashworth Scale is a standard clinical and research method to quantify spasticity.

Each of the 6 leg groups is given a scale of 0-4.

0 - Normal. No increase in muscle tone.

1. - Mild. Barely increased muscle tone. (catch)
2. - Moderate. Moderately increased muscle tone that can be overcome and full range of motion is possible. (catch and resistance)
3. - Severe. Severely increased muscle tone that is extremely difficult to overcome and full range of motion is not possible. (resistance and stop)
4. - Contracted. All groups are summed for a total score for each side of the body. Higher scores indicate greater spasticity. Lowest possible score is a 0 whereas the highest possible score for each side is 24.

**Measure:** Spasticity Measured by the Modified Ashworth Scale

**Time Frame:** at average of 4 months

**Description:** The modified MSSS-88 is a standardized self-report questionnaire to quantify subject's impact of the effects of spasticity.

The 88 questions each have a possible score of 1-4. All questions are totaled for a final total scores. Higher scores indicate greater spasticity. The lowest score is 88 and the highest possible is 352.

**Measure:** Multiple Sclerosis Spasticity Scale - 88 (MSSS-88)

**Time Frame:** at average of 4 months

**Description:** The BDI-II is a standardized self-report questionnaire to quantify depression.

The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Answers to 21 questions added together. Higher scores indicate greater depression. Lowest possible score is a 0 whereas highest 63.

**Measure:** Beck Depression Inventory II (BDI II)

**Time Frame:** at average of 4 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Diagnosis of definite MS

* At least 18 years old
* Able to walk 25 feet independently with common assistive devices if needed
* Presence of spasticity by self-report interfering with usual daily activities
* Have an email account and be familiar with using it
* Willing to track daily exercise for 4 weeks
* Fluent in English

Exclusion Criteria:

Other medical or behavioral conditions that would limit participation or completion of the study.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Portland

**Country:** United States

**Facility:** VA Portland Health Care System, Portland, OR

**State:** Oregon

**Zip:** 97239

#### Overall Officials

**Official 1:**

**Affiliation:** VA Portland Health Care System, Portland, OR

**Name:** Lucinda L Hugos, MS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000020278

- Term: Demyelinating Autoimmune Diseases, CNS

- ID: D000020274

- Term: Autoimmune Diseases of the Nervous System

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000003711

- Term: Demyelinating Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000009122

- Term: Muscle Hypertonia

- ID: D000020879

- Term: Neuromuscular Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC05

- Name: Musculoskeletal Diseases

### Condition Browse Module - Browse Leaves

- ID: M12060

- Name: Multiple Sclerosis

- Relevance: HIGH

- As Found: Multiple Sclerosis

- ID: M15415

- Name: Sclerosis

- Relevance: HIGH

- As Found: Sclerosis

- ID: M12085

- Name: Muscle Spasticity

- Relevance: HIGH

- As Found: Spasticity

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22098

- Name: Demyelinating Autoimmune Diseases, CNS

- Relevance: LOW

- As Found: Unknown

- ID: M22094

- Name: Autoimmune Diseases of the Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M6909

- Name: Demyelinating Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12079

- Name: Muscle Hypertonia

- Relevance: LOW

- As Found: Unknown

- ID: M22619

- Name: Neuromuscular Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009128

- Term: Muscle Spasticity

- ID: D000009103

- Term: Multiple Sclerosis

- ID: D000012598

- Term: Sclerosis

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** A Spasticity: Take Control

**Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures

Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures

**ID:** EG000

**Other Num Affected:** 1

**Other Num at Risk:** 19

**Serious Number At Risk:** 19

**Title:** A Spasticity: Take Control

**Group ID:** EG001

**Title:** B Usual Care

**Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures

Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures

**ID:** EG001

**Other Num Affected:** 5

**Other Num at Risk:** 19

**Serious Number At Risk:** 19

**Title:** B Usual Care

**Frequency Threshold:** 0

#### Other Events

**Term:** Concussion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Leg spasms

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** UTI

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** 

**Term:** Broken arm resulting from fall

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** 

**Term:** Pain and bruising from fall

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** 

**Term:** Increase in urinary urgency

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** 

**Time Frame:** 2 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Group ID:** BG001

**Value:** 20

**Group ID:** BG002

**Value:** 40

**Units:** Participants

### Group

**ID:** BG000

**Title:** A Spasticity: Take Control

**Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures

Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures

### Group

**ID:** BG001

**Title:** B Usual Care

**Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures

Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 18

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 36

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 4

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 12.79

**Value:** 53.38

#### Measurement

**Group ID:** BG001

**Spread:** 12.34

**Value:** 52.83

#### Measurement

**Group ID:** BG002

**Spread:** 12.56

**Value:** 53.1

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 13

#### Measurement

**Group ID:** BG001

**Value:** 16

#### Measurement

**Group ID:** BG002

**Value:** 29

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 11

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 20

#### Measurement

**Group ID:** BG001

**Value:** 20

#### Measurement

**Group ID:** BG002

**Value:** 40

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** hugosc@ohsu.edu
**Organization:** VA Research and Development
**Phone:** 503-220-8262
**Phone Extension:** 52338
**Title:** Cinda Hugos, Physical Therapist
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.84
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.738
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.8434
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.638
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.492
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** This analysis refers to the physical component of the MSIS-29
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.144
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** This refers to the psychological analysis for the MSIS-29.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.953
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 7
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.915
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 8
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.023
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
### Outcome Measure 9
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.11
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon (Mann-Whitney)
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 27.3
- **Upper Limit:** 
- **Value:** 72.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 30.8
- **Upper Limit:** 
- **Value:** 82.2
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7
- **Upper Limit:** 
- **Value:** 7.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 10.4
- **Upper Limit:** 
- **Value:** 9.4
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 9.69
- **Upper Limit:** 
- **Value:** 11.23
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 13.51
- **Upper Limit:** 
- **Value:** 13.82
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 150.5
- **Upper Limit:** 
- **Value:** 462.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 158.7
- **Upper Limit:** 
- **Value:** 412.5
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 19.2
- **Upper Limit:** 
- **Value:** 41.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 20.8
- **Upper Limit:** 
- **Value:** 43.5
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 17.2
- **Upper Limit:** 
- **Value:** 45.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 19.2
- **Upper Limit:** 
- **Value:** 52.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.6
- **Upper Limit:** 
- **Value:** 18.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.6
- **Upper Limit:** 
- **Value:** 20.6
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 9.5
- **Upper Limit:** 
- **Value:** 10.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 9.3
- **Upper Limit:** 
- **Value:** 10.8
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 53.3
- **Upper Limit:** 
- **Value:** 165.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 58.8
- **Upper Limit:** 
- **Value:** 192.4
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.5
- **Upper Limit:** 
- **Value:** 9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8
- **Upper Limit:** 
- **Value:** 11.5
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The MSWS-12 is a clinically validated and reliable tool that is flexible and simple enough to use clinically and in research. It captures patients' perspectives on their ambulatory disability on the following: standing, ability to run, need for support, moving around the home, concentration needed to walk, walking speed, maintaining balance, climbing stairs, walking distance, effort needed to walk, ability to walk, and gait. It is simple to administer and responsive to changes in patient performance over time.

Individual items are scored on a 5 point Likert scale: 1 (Not at all), 2 (A little), 3 (Moderately), 4 (Quite a bit), 5 (Extremely). A total score is generated and reported on a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12, or 48), and multiplying. Higher values represent a worse outcome and greater disability.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** at average of 4 months
**Title:** MS Walking Scale-12 (MSWS-12)
**Type:** PRIMARY
**Unit of Measure:** units on a scale
##### Group
**Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures

Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
**ID:** OG000
**Title:** A Spasticity: Take Control
##### Group
**Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures

Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures
**ID:** OG001
**Title:** B Usual Care
#### Outcome Measure 2
**Description:** The time to walk 25 feet is strongly related to its ordinal counterpart the Ambulation Index (Spearman r=0.91) without the variability the ordinal scale reflects.

The time is measured and recorded in seconds how long it takes for the participant to walk 25 feet.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** One subject was unable to complete this physical assessment at the visit.
**Reporting Status:** POSTED
**Time Frame:** at average of 4 months
**Title:** Timed 25 Foot Walk
**Type:** SECONDARY
**Unit of Measure:** seconds
##### Group
**Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures

Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
**ID:** OG000
**Title:** A Spasticity: Take Control
##### Group
**Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures

Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures
**ID:** OG001
**Title:** B Usual Care
#### Outcome Measure 3
**Description:** The Timed Up and Go (TUG) test measures the time in seconds it takes to get up from a chair, walk 10 feet, turn around and return to sit in the chair.

The best score of the two attempts was analyzed.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** One subject was unable to complete this physical assessment at the visit.
**Reporting Status:** POSTED
**Time Frame:** at average of 4 months
**Title:** Timed up and go Test
**Type:** SECONDARY
**Unit of Measure:** seconds
##### Group
**Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures

Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
**ID:** OG000
**Title:** A Spasticity: Take Control
##### Group
**Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures

Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures
**ID:** OG001
**Title:** B Usual Care
#### Outcome Measure 4
**Description:** The subject walks without assistance of another person for 2 minutes. The distance in feet the individual was able to walk in 2 minutes is then measured.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** One subject was unable to complete this physical assessment at the visit.
**Reporting Status:** POSTED
**Time Frame:** at average of 4 months
**Title:** 2 Minute Walk Test
**Type:** SECONDARY
**Unit of Measure:** feet
##### Group
**Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures

Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
**ID:** OG000
**Title:** A Spasticity: Take Control
##### Group
**Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures

Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures
**ID:** OG001
**Title:** B Usual Care
#### Outcome Measure 5
**Description:** This self-report retrospective questionnaire measures fatigue symptoms. It consists of 21 items scored 0-4 for a total score between 0 and 84 and has a coefficient alpha of 0.81. Lower scores on the MFIS indicate less fatigue.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** at average of 4 months
**Title:** Modified Fatigue Impact Scale (MFIS)
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures

Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
**ID:** OG000
**Title:** A Spasticity: Take Control
##### Group
**Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures

Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures
**ID:** OG001
**Title:** B Usual Care
#### Outcome Measure 6
**Description:** The MSIS-29 is designed to measure the physical and psychological impact of MS.

Each subscale summed separately. No total calculated. Scores transformed to have a range of 0-100. Lower scores indicate less impact, higher scores indicate higher impact.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** at average of 4 months
**Title:** Multiple Sclerosis Impact Scale (MSIS-29)
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures

Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
**ID:** OG000
**Title:** A Spasticity: Take Control
##### Group
**Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures

Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures
**ID:** OG001
**Title:** B Usual Care
#### Outcome Measure 7
**Description:** The modified Ashworth Scale is a standard clinical and research method to quantify spasticity.

Each of the 6 leg groups is given a scale of 0-4.

0 - Normal. No increase in muscle tone.

1. - Mild. Barely increased muscle tone. (catch)
2. - Moderate. Moderately increased muscle tone that can be overcome and full range of motion is possible. (catch and resistance)
3. - Severe. Severely increased muscle tone that is extremely difficult to overcome and full range of motion is not possible. (resistance and stop)
4. - Contracted. All groups are summed for a total score for each side of the body. Higher scores indicate greater spasticity. Lowest possible score is a 0 whereas the highest possible score for each side is 24.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** at average of 4 months
**Title:** Spasticity Measured by the Modified Ashworth Scale
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures

Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
**ID:** OG000
**Title:** A Spasticity: Take Control
##### Group
**Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures

Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures
**ID:** OG001
**Title:** B Usual Care
#### Outcome Measure 8
**Description:** The modified MSSS-88 is a standardized self-report questionnaire to quantify subject's impact of the effects of spasticity.

The 88 questions each have a possible score of 1-4. All questions are totaled for a final total scores. Higher scores indicate greater spasticity. The lowest score is 88 and the highest possible is 352.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** at average of 4 months
**Title:** Multiple Sclerosis Spasticity Scale - 88 (MSSS-88)
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures

Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
**ID:** OG000
**Title:** A Spasticity: Take Control
##### Group
**Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures

Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures
**ID:** OG001
**Title:** B Usual Care
#### Outcome Measure 9
**Description:** The BDI-II is a standardized self-report questionnaire to quantify depression.

The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Answers to 21 questions added together. Higher scores indicate greater depression. Lowest possible score is a 0 whereas highest 63.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** at average of 4 months
**Title:** Beck Depression Inventory II (BDI II)
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures

Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
**ID:** OG000
**Title:** A Spasticity: Take Control
##### Group
**Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures

Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures
**ID:** OG001
**Title:** B Usual Care
### Participant Flow Module
#### Group
**Description:** 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures

Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
**ID:** FG000
**Title:** A Spasticity: Take Control
#### Group
**Description:** 2 visits: baseline and given usual treatment of brochure for stretching, outcome measures

Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures
**ID:** FG001
**Title:** B Usual Care
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 20
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 20
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 19
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 19
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1
**Has Results:** True