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

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

Myanmar

Study Type

Interventional

Intervention

Task-oriented home exercise

Usual Physiotherapy Care

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, task-oriented home exercise, walking competency, Usual Physiotherapy care

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

National Rehabilitation Hospital
Physical Medicine and Rehabilitation Department, Yangon General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Task-oriented Exercise

Usual Care

Arm Description

Structured, progressive, task-oriented, home exercise program

Usual Physiotherapy Care

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT02779036

First Posted

May 15, 2016

Last Updated

June 7, 2017

Sponsor

Mahidol University

Collaborators

University of Medical Technology, Yangon, National Rehabilitation Hospital, Myanmar, Yangon General Hospital, Myanmar

1. Study Identification

Unique Protocol Identification Number

NCT02779036

Brief Title

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

Acronym

TOHE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

June 2016 (undefined)

Primary Completion Date

April 2017 (Actual)

Study Completion Date

April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mahidol University

Collaborators

University of Medical Technology, Yangon, National Rehabilitation Hospital, Myanmar, Yangon General Hospital, Myanmar

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Stroke, task-oriented home exercise, walking competency, Usual Physiotherapy care

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Task-oriented Exercise

Arm Type

Experimental

Arm Description

Structured, progressive, task-oriented, home exercise program

Arm Title

Usual Care

Arm Type

Active Comparator

Arm Description

Usual Physiotherapy Care

Intervention Type

Procedure

Intervention Name(s)

Task-oriented home exercise

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Usual Physiotherapy Care

Intervention Description

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.

Primary Outcome Measure Information:

Title

6 Minutes Walk Test

Description

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.

Time Frame

up to 8 weeks

Title

10 Meter Walk Test

Description

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.

Time Frame

up to 8 weeks

Secondary Outcome Measure Information:

Title

Berg Balance Scale

Description

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.

Time Frame

up to 8 weeks

Title

Dynamic Gait Index

Description

Patients will be measured their walking adaptability by a blind assessor on two occasions:at baseline and 8 weeks after baseline testing.

Time Frame

Baseline and 8 weeks

Title

Stroke Impact Scale (Participation)

Description

Patients will be measured their community participation by a blind assessor on two occasions:at baseline and 8 weeks after baseline testing.

Time Frame

Baseline and 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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).

Overall Study Officials: