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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Procedure: Usual Physiotherapy Care; Procedure: Task-oriented home exercise

• Registration Number: NCT02779036
• Lead Sponsor: Mahidol University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-05-15
• Study First Submitted QC: 2016-05-19
• Study First Posted: 2016-05-20
• Study Start: 2016-06
• Status Verified: 2016-10
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Last Update Submitted: 2017-06-07
• Last Update Posted: 2017-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

1. Either side of both type first stroke within 2 weeks to six months of onset with confirmatory diagnosis by CT Scan and MRI.
2. Age between 40 to 65 years old.
3. Moderate severity of stroke measured by the modified Rankin Scale (mRS- 3)
4. Able to comprehend the instructions with good cognition measured by Mini-Mental State Examination (MMSE > 23).
5. Postadoption stage of readiness to change measured by the Stages of Change Questionnaire (stage 4 and 5)

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Exclusion Criteria

1. Diagnosed with other neurological disorder such as Parkinson's disease, peripheral nerve injury.
2. 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)
3. Fugl Meyer Assessment score (lower extremity) less than ≤ 21
4. Significant hip, knee and ankle contracture that would limit ambulation (Fugl Meyer (ROM) ≤1 in each joint).
5. Orthopedic and rheumatological disorder with weight bearing pain (Fugl Meyer (pain) ≤ 1 in hip, knee and ankle joint movement).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Physiotherapy Care	Usual Physiotherapy Care
Task-oriented Exercise	Task-oriented home exercise	Structured, progressive, task-oriented, home exercise program

Primary Outcome Measures

Name	Time	Method
6 Minutes Walk Test	up to 8 weeks	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.
10 Meter Walk Test	up to 8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Dynamic Gait Index	Baseline and 8 weeks	Patients will be measured their walking adaptability by a blind assessor on two occasions:at baseline and 8 weeks after baseline testing.
Berg Balance Scale	up to 8 weeks	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.
Stroke Impact Scale (Participation)	Baseline and 8 weeks	Patients will be measured their community participation by a blind assessor on two occasions:at baseline and 8 weeks after baseline testing.

Trial Locations

Locations (2)

National Rehabilitation Hospital; 🇲🇲 Yangon, Myanmar

Physical Medicine and Rehabilitation Department, Yangon General Hospital; 🇲🇲 Yangon, Myanmar