Optimizing Walking Function of Stroke Survivors by a Task-Oriented Home Exercise Program

Study Overview
=================
Brief Summary
-----------------
In a randomized-controlled study, the effects of a structured, progressive, task-oriented home exercise program to optimize walking competency will be evaluated in subacute stroke survivors.

Detailed Description
-----------------
The majority of stroke individuals unable to reenter their previous community life after they have had a stroke. Reintegration of community life by optimizing walking function is a major goal of stroke rehabilitation. Because not widely available inpatient rehabilitation, discharged with incomplete recovery, limited numbers of technically trained physical therapists, financial saving, and transportation difficulty, home-based stroke rehabilitation setting has been interested in many developing countries. Task- oriented exercise is well known and accepted approach to optimize walking function with underlying principles of motor control and motor learning theories. This approach has been used in the clinical setting with close supervision, but identification of appropriate protocol in the community environment is on progress. To date, no proper home exercise program based on task-oriental principle with minimal supervision for improving walking competency after stroke has been proposed in stroke rehabilitation. The purpose of this study is to investigate the effects of a structured, progressive, task- oriented home exercise program on walking competency in individual post stroke.

Official Title
-----------------
The Effects of a Structured, Progressive, Task-oriented Home Exercise Program on Walking Competency in Individual Post Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Procedure: Task-oriented home exercise
* Procedure: Usual Physiotherapy Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Either side of both type first stroke within 2 weeks to six months of onset with confirmatory diagnosis by CT Scan and MRI. Age between 40 to 65 years old. Moderate severity of stroke measured by the modified Rankin Scale (mRS- 3) Able to comprehend the instructions with good cognition measured by Mini-Mental State Examination (MMSE > 23). Postadoption stage of readiness to change measured by the Stages of Change Questionnaire (stage 4 and 5) Exclusion Criteria: Diagnosed with other neurological disorder such as Parkinson's disease, peripheral nerve injury. Serious cardiac conditions (angina and myocardial infarction during the previous month, resting heart rate of more than 120, a systolic blood pressure of more than 180 mm Hg, and a diastolic blood pressure of more than 100 mm Hg) Fugl Meyer Assessment score (lower extremity) less than ≤ 21 Significant hip, knee and ankle contracture that would limit ambulation (Fugl Meyer (ROM) ≤1 in each joint). Orthopedic and rheumatological disorder with weight bearing pain (Fugl Meyer (pain) ≤ 1 in hip, knee and ankle joint movement).

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Task-oriented Exercise<br>Structured, progressive, task-oriented, home exercise program | Procedure: Task-oriented home exercise<br>* Structured, walking related task-oriented home exercise program with three progressive steps, at moderate to high intensity, 60 minutes per session, three sessions per week for total 8 weeks.<br>|
| Active Comparator: Usual Care<br>Usual Physiotherapy Care | Procedure: Usual Physiotherapy Care<br>* Deficits-oriented free active and resisted lower extremity exercises with bicycling and overground walking , 60 minutes per session, three sessions per week for total 8 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Minutes Walk Test | Patients will be measured their walking distance by a blind assessor on five occasions:at baseline,1,2,5 and 8 weeks after baseline testing. | up to 8 weeks | 
| 10 Meter Walk Test | Patients will be measured their walking speed by a blind assessor on five occasions:at baseline,1,2,5 and 8 weeks after baseline testing. | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance Scale | Patients will be measured their walking balance by a blind assessor on five occasions:at baseline,1,2,5 and 8 weeks after baseline testing. | up to 8 weeks | 
| Dynamic Gait Index | Patients will be measured their walking adaptability by a blind assessor on two occasions:at baseline and 8 weeks after baseline testing. | Baseline and 8 weeks | 
| Stroke Impact Scale (Participation) | Patients will be measured their community participation by a blind assessor on two occasions:at baseline and 8 weeks after baseline testing. | Baseline and 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, task-oriented home exercise, walking competency, Usual Physiotherapy care