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

June 7, 2017 updated by: Thin Thin Moe, Mahidol University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Task-oriented Exercise
Structured, progressive, task-oriented, home exercise program
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.
ACTIVE_COMPARATOR: Usual Care
Usual Physiotherapy Care
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 Minutes Walk Test
Time Frame: 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.
up to 8 weeks
10 Meter Walk Test
Time Frame: 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.
up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance Scale
Time Frame: 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.
up to 8 weeks
Dynamic Gait Index
Time Frame: 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.
Baseline and 8 weeks
Stroke Impact Scale (Participation)
Time Frame: 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.
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (ACTUAL)

April 1, 2017

Study Completion (ACTUAL)

April 1, 2017

Study Registration Dates

First Submitted

May 15, 2016

First Submitted That Met QC Criteria

May 19, 2016

First Posted (ESTIMATE)

May 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 8, 2017

Last Update Submitted That Met QC Criteria

June 7, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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