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

Stroke Clinical Trial

— TOHE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02779036
• Other study ID #: 3-2016
• Status: Completed
• Phase: N/A
• First received: May 15, 2016
• Last updated: June 7, 2017
• Start date: June 2016
• Est. completion date: April 2017

Study information

• Verified date: October 2016
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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)

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).

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• Task-oriented home exercise
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.
• Usual Physiotherapy Care
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.

Locations

Country	Name	City	State
Myanmar	National Rehabilitation Hospital	Yangon
Myanmar	Physical Medicine and Rehabilitation Department, Yangon General Hospital	Yangon

Sponsors (4)

Lead Sponsor	Collaborator
Mahidol University	National Rehabilitation Hospital, Myanmar, University of Medical Technology (Yangon) Myanmar, Yangon General Hospital, Myanmar

Country where clinical trial is conducted

Myanmar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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