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

NCT ID: NCT02779036

Last Updated: 2017-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-04-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Task-oriented Exercise

Structured, progressive, task-oriented, home exercise program

Group Type: EXPERIMENTAL

Task-oriented home exercise

Intervention Type: 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 Care

Usual Physiotherapy Care

Group Type: ACTIVE_COMPARATOR

Usual Physiotherapy Care

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Medical Technology, Yangon

OTHER

Sponsor Role: collaborator

National Rehabilitation Hospital, Myanmar

UNKNOWN

Sponsor Role: collaborator

Yangon General Hospital, Myanmar

UNKNOWN

Sponsor Role: collaborator

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Thin Thin Moe

Ph D candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thin Thin Moe, M.Med.Tech

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Chutima Jalayondeja, Dr.P.H. MSc

Role: STUDY_CHAIR

Mahidol University

Sopa Pichaiyongwongdee, M.Sc. B.Sc

Role: STUDY_DIRECTOR

Mahidol University

Vimonwan Hiengkaew, PhD. MSc

Role: STUDY_DIRECTOR

Mahidol University

Jarugool Tretriluxana, PhD. MSc

Role: STUDY_DIRECTOR

Mahidol University

Locations

National Rehabilitation Hospital

Yangon, , Burma

Physical Medicine and Rehabilitation Department, Yangon General Hospital

Yangon, , Burma

Countries

Burma

Other Identifiers

3-2016

Identifier Type: -

Identifier Source: org_study_id