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Completed

NCT Number: NCT02779036

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Rehabilitation Hospital, Yangon, Burma

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Task-oriented home exercise

Procedure

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

Procedure

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: TOHE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 20, 2016
Registry last updated
Jun 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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