Clinical trial NCT02779036: Optimizing Walking Function of Stroke Survivors by a Task-Oriented Home Exercise Program
Official title: The Effects of a Structured, Progressive, Task-oriented Home Exercise Program on Walking Competency in Individual Post Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
task-oriented home exercise
walking competency
Usual Physiotherapy care
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: University of Medical Technology, Yangon
name: National Rehabilitation Hospital, Myanmar
name: Yangon General Hospital, Myanmar
First posted: 2016-05-20
Enrollment: 63
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: 6 Minutes Walk Test
timeFrame: up to 8 weeks
measure: 10 Meter Walk Test
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: up to 8 weeks
measure: Dynamic Gait Index
timeFrame: Baseline and 8 weeks
measure: Stroke Impact Scale (Participation)
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Yangon
country: Myanmar
facility: National Rehabilitation Hospital
city: Yangon
country: Myanmar
facility: Physical Medicine and Rehabilitation Department, Yangon General Hospital
Study officials:
affiliation: Mahidol University
name: Thin Thin Moe, M.Med.Tech
role: PRINCIPAL_INVESTIGATOR
affiliation: Mahidol University
name: Chutima Jalayondeja, Dr.P.H. MSc
role: STUDY_CHAIR
affiliation: Mahidol University
name: Sopa Pichaiyongwongdee, M.Sc. B.Sc
role: STUDY_DIRECTOR
affiliation: Mahidol University
name: Vimonwan Hiengkaew, PhD. MSc
role: STUDY_DIRECTOR
affiliation: Mahidol University
name: Jarugool Tretriluxana, PhD. MSc
role: STUDY_DIRECTOR
References: