## Protocol Section
### Identification Module
**NCT ID:** NCT04491279

**Brief Title:** Neuropilates Compared to General Exercise Classes in Chronic Stroke

**Official Title:** An Investigation Into Neuropilates on Motor Function in Chronic Stroke: a Pilot Randomised Feasibility Study

#### Organization Study ID Info
**ID:** ITSligo EC
#### Organization
**Class:** OTHER
**Full Name:** Institute of Technology, Sligo
### Status Module
#### Completion Date
**Date:** 2022-01-31

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2020-08-11

**Type:** ACTUAL

**Last Update Submit Date:** 2020-08-09

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-04-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-10-30

**Type:** ESTIMATED

**Status Verified Date:** 2020-08

#### Study First Post Date
**Date:** 2020-07-29
**Type:** ACTUAL
**Study First Submit Date:** 2020-07-25
**Study First Submit QC Date:** 2020-07-28
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Sligo General Hospital

**Class:** OTHER

**Name:** Institute of Technology, Sligo

#### Lead Sponsor

**Class:** OTHER

**Name:** Dr. John Bartlett

#### Responsible Party

**Investigator Affiliation:** Institute of Technology, Sligo

**Investigator Full Name:** Dr. John Bartlett

**Investigator Title:** Head of Research

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This is a pilot randomised controlled feasibility study investigating the effects of a neuropilates exercise class compared to a generalised exercise in the post stroke population. This study is being conducted as part of an MSc qualification at the Institute of Technology, Sligo in Ireland. The study will be conducted in conjunction with Sligo University Hospital and it attained ethical approval through the relevant University Hospital Ethics Committee.

**Detailed Description:** Pilates is an exercise form created by Joseph Pilates in the 1920s. It is a programme of mind-body exercise focusing on strength, core stability, flexibility, muscle control, posture and breathing. Neuropilates is the practice of clinical pilates in patients with a neurological condition. The exercise is ideally led by a clinician with experience and expertise in the area and uses postural, positional and equipment adaptations as necessary to suit the needs of the client. The benefits derived from pilates exercise of balanced strength with improved alignment, postural control and flexibility, could be favourable to post stroke patients who often have one-sided loss of strength and muscle length and subsequent adverse postural adaptations and abnormal movement patterns.

This study aims to investigate the effects of a 6-week neuropilates class in post stroke patients, when compared with a 6-week generalised exercise class. Participants will be assessed before and after partaking in either class in order to examine their gait, functional independence and spasticity. Participants will then be randomly assigned to either the 6-week neuropilates class or generalised exercise class. Participants will be 6 or more months post stroke and finished their formal rehabilitation. Participants should not be involved with any other rehabilitation therapies / hydrotherapy / gym services for the duration of the study. We will aim to recruit 30 participants to the study. The intervention group will attend a once-weekly 60-minute neuropilates exercise class over 6 weeks facilitated by the principle investigator (a chartered physiotherapist who is also a pilates instructor). The control group will attend a once weekly, 60-minute generalized exercise class which will be designed by a chartered physiotherapist to address strength, cardiorespiratory fitness and mobility. Both exercise classes will take place in the Physiotherapy Department in St. John's Hospital, Sligo, Ireland

### Conditions Module

**Conditions:**

- Stroke

**Keywords:**

- Neuroplasticity

- Neuropilates

- Chronic Stroke

- Rehabilitation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Pilot Randomised Controlled Trial

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Outcome assessor will be blinded to treatment allocation. They will evaluate participant's prior to neuropilates treatment commencing and after neuropilates 6 week treatment has been completed.

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Will attend a once-weekly 60-minute neuropilates exercise class over 6 weeks facilitated by the principle investigator (chartered physiotherapist and pilates instructor).

Pitched at a beginner level focused on the core elements of neuropilates and progressing week on week as appropriate.

Includes a warm up, cool down and neuropilates exercises in line with the teaching of APPI (the Australian Physiotherapy and Pilates Institute). Exercises may be completed on mats, chairs, gym balls, plinths and in standing, depending upon the ability level of the participant.

Two classes running with 8 participants in each based on their initial assessment into the higher and lower functionally independent participants.

Participants will be given a home exercise programme weekly based on exercises from the class and will be asked to complete these independently at home twice more during the week and to keep a training diary.

**Intervention Names:**

- Procedure: Home 'Neuropilates' exercise instructions.

- Procedure: Supervised Neuropilates Group Class

**Label:** Neuropilates class.

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Will attend a once weekly, 60-minute generalized exercise class which will be designed by a chartered physiotherapist to address strength, cardiorespiratory fitness and mobility.

Exercises will be more functional and generic than in the pilates classes and will be conducted in a circuit style, including mobility practice, sit to stand practice, cycling with the motomed, and general upper and lower limb strengthening. Warm up and cool downs will also be a feature of this class.

Participants will be also be given a home exercise programme based on exercises completed in the class and will be asked to complete these exercises twice more during the week and to keep a training diary.

**Intervention Names:**

- Procedure: Home 'General' exercise instructions.

- Procedure: Supervised General Exercises Group Class

**Label:** Generalised exercise class.

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Generalised exercise class.

**Description:** Participants will be given a home exercise programme weekly based on exercises from the general exercise class and will be asked to complete these independently at home twice more during the week and to keep a training diary.

**Name:** Home 'General' exercise instructions.

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Neuropilates class.

**Description:** Participants will be given a home exercise programme weekly based on exercises from the neuropilates exercise class and will be asked to complete these independently at home twice more during the week and to keep a training diary.

**Name:** Home 'Neuropilates' exercise instructions.

**Type:** PROCEDURE

#### Intervention 3

**Arm Group Labels:**

- Neuropilates class.

**Description:** Will attend a once-weekly 60-minute neuropilates exercise class over 6 weeks facilitated by the principle investigator (a chartered physiotherapist who is also a pilates instructor).

**Name:** Supervised Neuropilates Group Class

**Type:** PROCEDURE

#### Intervention 4

**Arm Group Labels:**

- Generalised exercise class.

**Description:** Will attend a once weekly, 60-minute generalized exercise class which will be designed by a chartered physiotherapist to address strength, cardiorespiratory fitness and mobility

**Name:** Supervised General Exercises Group Class

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** A performance-based scale to assess everyday motor function in post stroke patients. Evaluation is based upon a task-orientated approach. The scale comprises 8 items corresponding to 8 areas of motor function. Patients perform each task 3 times and the best performance is recorded. Tasks include; Supine to side lying, Supine to sitting over the edge of a bed, Balanced sitting, Sitting to standing, Walking, Upper-arm function, Hand movements, Advanced hand activities.

General tonus of the affected side is also measured. All items (with the exception of the general tonus item) are assessed using a 7-point scale from 0 - 6. A score of 6 indicates optimal motor behaviour. For the general tonus item, the score is based on continuous observations throughout the assessment. A score of 4 on this item indicates a consistently normal response. A score \> 4 indicates persistent hypertonus and a score \< 4 indicates various degrees of hypotonus. The maximum score possible is 48 points.

**Measure:** Motor Assessment Scale (Carr and Shepherd 1985).

**Time Frame:** Over a 6 week period. (15 min testing time).

#### Secondary Outcomes

**Description:** Assesses functional mobility and can be used as a screening tool for detecting potential balance impairments and falls risk in older adults. During the test the subject must rise from a chair, walk 3 metres at a comfortable pace to a mark placed on the floor, turn around at the 3 metre mark, walk back to the starting point, and return to sitting in the chair. The test's score is the time it takes the subject takes to complete the test. The longer it takes the poorer the patient function.If a subject takes longer than 14 seconds to complete the test, they are considered to be at a high risk of falling.

**Measure:** Gait Analysis: Timed Up and Go Test (Shumway-Cook et al, 2000).

**Time Frame:** Over a 6 week period. (1 min testing time).

**Description:** Most commonly accepted method of evaluating muscle strength. It involves testing key muscles from the upper and lower limbs against resistance applied by the examiner. The subject's strength is graded on a 0 - 5 scale with 0 being no movement or muscle activity visible or palpable and 5 being full strength through full range against strong resistance. It can take a few minutes up to 20 minutes to test, depending on the experience level of the examiner, the ability of the subject and the number of muscle groups being tested.

**Measure:** Muscle Strength: Oxford Grading Scale.

**Time Frame:** Over a 6 week period. (5-20 min testing time).

**Description:** Measure muscle tone. During testing, the examiner extends the subject's limb from a position of maximal flexion to maximal extension until the first soft resistance is felt. Moving a client's limb through its full range of motion should be done within one second by counting "one thousand and one" Scores range from 0 to 4 where lower scores represent normal muscle tone and higher scores represent increased tone (spasticity) or increased resistance to passive movement. Again, time varies greatly depending on number of muscles being tested, examiner experience and patient ability, and can range from 5 minutes to 20 minutes.

**Measure:** Spasticity: Modified Ashworth Scale (Bohannon and Smith 1987).

**Time Frame:** Over a 6 week period. (5-20 min testing time).

**Description:** The FIM is a valid, reliable, 18-item global measure of disability, which is responsive to functional change. The FIM assesses six areas of function (Self-care, Sphincter control, Transfers, Locomotion, Communication and Social cognition), which fall under two Domains (Motor and Cognitive). Each item on the FIM is scored on a 7-point Likert scale. The score indicates the amount of assistance required to perform each item (1 = total assistance in all areas, 7 = total independence in all areas). The ratings are based on performance rather than capacity and can be acquired by observation, patient interview, telephone interview or medical records. The developers of the FIM recommend that the scoring be derived by consensus with a multi-disciplinary team. The final score can range from 18 - 126 points, where 18 represents complete dependence or total assistance and 126 represents complete independence.

**Measure:** Function: Functional Independence Measure (FIM), (Granger et al 1993).

**Time Frame:** Over a 6 week period. (30-45 min testing time).

**Description:** Generates a profile of handicaps on 6 different dimensions, including mobility, independence, occupation, social integration, orientation, and economic self-sufficiency. Each dimension has six levels arranged in order of increasing disadvantage with 1 being no disadvantage and 6 being most severe disadvantage. An overall handicap severity score is generated.

**Measure:** London Handicap Scale (LHS), (Harwood et al 1994).

**Time Frame:** Over a 6 week period. (5 min testing time).

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Aged \> 18 years
2. Diagnosis of chronic stroke (\>6 months post stroke event, as defined by Bernhardt et al, 2017) and formal rehabilitation completed.
3. Able to transfer (sit to stand and lateral transfers) independently with or without assistive device
4. Access to transport to enable attendance at one class per week
5. Cognitive ability to understand the programme.

Exclusion Criteria:

1. Involvement in other studies or rehabilitation programmes.
2. Severe cognitive deficits or difficulty following instructions.
3. Significant hearing difficulties.
4. Significant visual deficit
5. Uncontrolled pain or uncontrolled high blood pressure

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** monaghan.kenneth@itsligo.ie

**Name:** Kenneth Monaghan, PhD

**Phone:** 0879480448

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Sligo

**Country:** Ireland

**Facility:** Institute of Technology, Sligo

**State:** Co Sligo

**Zip:** F91YW50

#### Overall Officials

**Official 1:**

**Affiliation:** Study Principal Investigator

**Name:** Eimear Cronin, MSc Res

**Role:** PRINCIPAL_INVESTIGATOR

## Document Section

### Large Document Module

#### Large Docs

- Date: 2020-08-04

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 246122

- Type Abbrev: Prot

- Upload Date: 2020-08-05T02:56

- Date: 2020-08-04

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 176437

- Type Abbrev: SAP

- Upload Date: 2020-08-05T02:57

- Date: 2020-08-04

- Filename: ICF_002.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 420861

- Type Abbrev: ICF

- Upload Date: 2020-08-09T04:26

## 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

- Abbrev: Rare

- Name: Rare Diseases

### 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

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020521

- Term: Stroke

### Misc Info Module

- Version Holder: 2024-05-24
