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CompletedNCT02779036TOHEUpdated Jun 8, 2017

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

An interventional study of Task-oriented home exercise and Usual Physiotherapy Care in Stroke, sponsored by Mahidol University. Completed at 2 sites in Myanmar. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-06-08.

Sponsored by Mahidol University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stroke

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Keywords

  • Stroke
  • task-oriented home exercise
  • walking competency
  • Usual Physiotherapy care
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's enrollment of 63 is above the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (MMSE > 23).
  5. Postadoption stage of readiness to change measured by the Stages of Change Questionnaire (stage 4 and 5)

Exclusion criteria

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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    Task-oriented Exercise

    Structured, progressive, task-oriented, home exercise program

    Procedure: Task-oriented home exercise

  • Active comparator
    Usual Care

    Usual Physiotherapy Care

    Procedure: Usual Physiotherapy Care

Interventions

  • ProcedureTask-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.

  • ProcedureUsual 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 8 weeks

  2. 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.

    Time frame: up to 8 weeks

Secondary outcomes

  1. 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.

    Time frame: up to 8 weeks

  2. 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.

    Time frame: Baseline and 8 weeks

  3. 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.

    Time frame: Baseline and 8 weeks

07

Study locations

2 sites
  • National Rehabilitation Hospital
    Yangon, Myanmar
  • Physical Medicine and Rehabilitation Department, Yangon General Hospital
    Yangon, Myanmar
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2016, a primary completion of Apr 2017 and a completion of Apr 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 15, 2016
First posted
May 20, 2016
Start
Jun 2016
Primary completionActual
Apr 2017
CompletionActual
Apr 2017
Last update
Jun 8, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02779036
Lead sponsor
Mahidol University
Collaborators
University of Medical Technology, Yangon, National Rehabilitation Hospital, Myanmar, Yangon General Hospital, Myanmar
Responsible party
Thin Thin Moe (Ph D candidate, Mahidol University) — Principal investigator
First posted
May 20, 2016
Start date
Jun 2016
Primary completion
Apr 2017
Completion
Apr 2017
Last update
Jun 8, 2017

Study contacts

Thin Thin Moe, M.Med.Tech
principal investigator · Mahidol University
Chutima Jalayondeja, Dr.P.H. MSc
study chair · Mahidol University
Sopa Pichaiyongwongdee, M.Sc. B.Sc
study director · Mahidol University
Vimonwan Hiengkaew, PhD. MSc
study director · Mahidol University
Jarugool Tretriluxana, PhD. MSc
study director · Mahidol University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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