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

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ClinicalTrials.gov Identifier: NCT02779036
Recruitment Status : Completed
First Posted : May 20, 2016
Last Update Posted : June 8, 2017
Sponsor:
Collaborators:
University of Medical Technology (Yangon) Myanmar
National Rehabilitation Hospital, Myanmar
Yangon General Hospital, Myanmar
Information provided by (Responsible Party):
Thin Thin Moe, 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.

Condition or disease Intervention/treatment Phase
Stroke Procedure: Task-oriented home exercise Procedure: Usual Physiotherapy Care Not Applicable

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  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of a Structured, Progressive, Task-oriented Home Exercise Program on Walking Competency in Individual Post Stroke
Study Start Date : June 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02779036


Locations
Myanmar
National Rehabilitation Hospital
Yangon, Myanmar
Physical Medicine and Rehabilitation Department, Yangon General Hospital
Yangon, Myanmar
Sponsors and Collaborators
Mahidol University
University of Medical Technology (Yangon) Myanmar
National Rehabilitation Hospital, Myanmar
Yangon General Hospital, Myanmar
Investigators
Principal Investigator: Thin Thin Moe, M.Med.Tech Mahidol University
Study Chair: Chutima Jalayondeja, Dr.P.H. MSc Mahidol University
Study Director: Sopa Pichaiyongwongdee, M.Sc. B.Sc Mahidol University
Study Director: Vimonwan Hiengkaew, PhD. MSc Mahidol University
Study Director: Jarugool Tretriluxana, PhD. MSc Mahidol University

Responsible Party: Thin Thin Moe, Ph D candidate, Mahidol University
ClinicalTrials.gov Identifier: NCT02779036     History of Changes
Other Study ID Numbers: 3-2016
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Thin Thin Moe, Mahidol University:
Stroke
task-oriented home exercise
walking competency
Usual Physiotherapy care

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases