## Protocol Section
### Identification Module
**NCT ID:** NCT06426862

**Brief Title:** Effects of Otago Exercise Program in Falls, Balance and Physical Performance in Stroke Patients

**Official Title:** To Determine the Effects of the Otago Exercise Program on the Frequency of Falls, Balance Capabilities, and Overall Physical Performance in Stroke Patients.

#### Organization Study ID Info
**ID:** REC 01741 Muhammad Baqir
#### Organization
**Class:** OTHER
**Full Name:** Riphah International University
### Status Module
#### Completion Date
**Date:** 2024-10-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-26

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Riphah International University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study aims to determine the effects of the Otago Exercise Program (OEP) on falls and balance as well as overall physical performance. Participants will be divided into two groups; control and intervention group. It is a week-long study, the participants will be assessed through the Berg Balance Scale (BBS), Time Up and Go (TUG) and Fugl-Meyer Assessment (FMA).

**Detailed Description:** The previous literature suggested that the Otago exercise showed significant improvement in terms of fall and balance. Most of the Studies were conducted on the elderly population but limited studies are available regarding stroke. This study will look at the effect of Otago exercise on stroke patients. The Otago exercise consists of 17 exercises; strengthening and balancing exercises. The participants will receive Otago exercise and routine physiotherapy treatment for six weeks. The participants will go through three assessments; Baseline Assessment, After 3 weeks assessment and final assessment. For association, a mixed method ANOVA test will be used.

### Conditions Module

**Conditions:**

- Stroke

**Keywords:**

- Stroke

- Cardiovascular Attack

- Otago Exercise Program

- Berg Balance Scale

- Time Up & Go Test

- Fugl-Meyer Assessment

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The interventional group will receive both treatment routine physiotherapy and the Otago exercise program (OEP). The OEP is the exercise designed for strength and balance to improve mobility, functional balance and walking. The exercises included in this protocol are 17: strength, balance and walking. The participants will receive this protocol with 10 repetitions while the interval between exercises will not be fixed; patients will be given ample time to relax and recuperate before beginning another exercise, 3 times a week for six weeks and the time duration will be 30 to 45 minutes. The exercises will be progressively administered weekly.

**Intervention Names:**

- Other: Otago Exercise Program

- Other: Control Group

**Label:** Interventional Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The control group will receive routine treatment of physiotherapy for strokes like strengthening of upper and lower limb muscles (knee flexor, hip adductor and ankle dorsiflexor), stretching (hip abductors and ankle plantar flexor), postural awareness, gait and balance training like static and dynamic. The participants will be assessed through baseline assessment.

**Intervention Names:**

- Other: Control Group

**Label:** Control group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Interventional Group

**Description:** Otago exercise program

Strengthening Exercise Knee extensor, Hip adductors, heel and toe raising

Balance exercise Sit to stand, Knee bending, one leg standing, tandem stance, side walk, walk and turn around, tandem walk, backward walk, heel and toe walk, stair climbing

**Name:** Otago Exercise Program

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Control group

- Interventional Group

**Description:** Routine physiotherapy like strengthening, stretching, postural awareness, gait and balance training.

**Name:** Control Group

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The BBS was used to assess the quantitative measure of balance and fall risk among the older population through direct observation of their performance. The 14 items scale of total scoring 56 and each item has a scaling of 0 to 4. The scoring up to 0 to 20 represents impaired balance, 21 to 40 indicate acceptable while \>40 represent good balance.

**Measure:** Berg Balance Scale

**Time Frame:** Baseline

**Description:** The BBS was used to assess the quantitative measure of balance and fall risk among the older population through direct observation of their performance. The 14 items scale of total scoring 56 and each item has a scaling of 0 to 4. The scoring up to 0 to 20 represents impaired balance, 21 to 40 indicate acceptable while \>40 represent good balance.

**Measure:** Berg Balance Scale

**Time Frame:** After 3 weeks

**Description:** The BBS was used to assess the quantitative measure of balance and fall risk among the older population through direct observation of their performance. The 14 items scale of total scoring 56 and each item has a scaling of 0 to 4. The scoring up to 0 to 20 represents impaired balance, 21 to 40 indicate acceptable while \>40 represent good balance.

**Measure:** Berg Balance Scale

**Time Frame:** After 6 weeks

**Description:** The TUG test was used to assess the functional mobility of the participants. The gait and balance maneuvers used in daily life are attributed to functional mobility. The participants were required to stand up, walk away through 3 meters or 10 feet and turn back to sit in the chair at starting. The individuals who cover the distance in \>20 seconds are considered as dependent in their activities while those who complete the task in \<20 sec indicate independence in ADLs.

**Measure:** Time Up & Go Test

**Time Frame:** Baseline

**Description:** The TUG test was used to assess the functional mobility of the participants. The gait and balance maneuvers used in daily life are attributed to functional mobility. The participants were required to stand up, walk away through 3 meters or 10 feet and turn back to sit in the chair at starting. The individuals who cover the distance in \>20 seconds are considered as dependent in their activities while those who complete the task in \<20 sec indicate independence in ADLs.

**Measure:** Time Up & Go Test

**Time Frame:** After 3 weeks

**Description:** The TUG test was used to assess the functional mobility of the participants. The gait and balance maneuvers used in daily life are attributed to functional mobility. The participants were required to stand up, walk away through 3 meters or 10 feet and turn back to sit in the chair at starting. The individuals who cover the distance in \>20 seconds are considered as dependent in their activities while those who complete the task in \<20 sec indicate independence in ADLs.

**Measure:** Time Up & Go Test

**Time Frame:** After 6 weeks

**Description:** Motor impairment is the most common complication of stroke; it was measured by FMA quantitatively. The scale is divided into 5 domains; sensory \& motor function, balance, joint range of motion and joint pain. Each domain has a scale of 0 to 2 score while the total scoring of the scale is 226 score.

**Measure:** Fugl-Meyer Assessment

**Time Frame:** Baseline

**Description:** Motor impairment is the most common complication of stroke; it was measured by FMA quantitatively. The scale is divided into 5 domains; sensory \& motor function, balance, joint range of motion and joint pain. Each domain has a scale of 0 to 2 score while the total scoring of the scale is 226 score.

**Measure:** Fugl-Meyer Assessment

**Time Frame:** After 3 weeks

**Description:** Motor impairment is the most common complication of stroke; it was measured by FMA quantitatively. The scale is divided into 5 domains; sensory \& motor function, balance, joint range of motion and joint pain. Each domain has a scale of 0 to 2 score while the total scoring of the scale is 226 score.

**Measure:** Fugl-Meyer Assessment

**Time Frame:** After 6 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Ischemic or hemorrhagic stroke
* Medically stable patients with acute to subacute level of stroke recovery (\< 6 month).
* Patients 40 plus age
* Berg balance scale \<45 and \>20 score
* TUG test scoring \>20 sec

Exclusion Criteria:

* Participants having cognition problem or language barrier
* Physical disability (fracture or amputation) other than stroke
* Previous surgery 6 weeks
* Cardiovascular and pulmonary disease

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Baqirm409@gmail.com

**Name:** Muhammad Baqir, MS

**Phone:** +923129008037

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Peshawar

**Contacts:**

***Contact 1:***

- **Email:** imran.amjad@riphah.edu.pk

- **Name:** Imran Amjad, Phd

- **Phone:** +92 332 4390125

- **Role:** CONTACT

**Country:** Pakistan

**Facility:** Muhammad Baqir

**State:** KPK

**Status:** RECRUITING

**Zip:** 25000

#### Overall Officials

**Official 1:**

**Affiliation:** Riphah International University

**Name:** IMRAN AMJAD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M22306

- Name: Stroke

- Relevance: HIGH

- As Found: Stroke

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020521

- Term: Stroke

### Misc Info Module

- Version Holder: 2024-05-31
