Effect of Structured Progressive Task-Oriented Circuit Class Training With Motor Imagery on Gait in Stroke

March 2, 2021 updated by: Mahidol University

Effect of a Structured Progressive Task-Oriented Circuit Class Training Program With Motor Imagery on Gait Performance in Patients With Stroke: A Randomized Double Blind Balanced Parallel-Group

The objectives of the study will be General Objective is to investigate the effect of TOCCT with MI on gait performance in patients with stroke. Speific Objevtives.

Specific Objectives are to compare the effect of TOCCT with MI and TOCCT with education on the spatio-temporal and functional gait variables in patients with stroke, to investigate the spatio-temporal and functional gait variables in patients with stroke after receiving TOCCT with MI and to investigate the spatio-temporal and functional gait variables in patients with stroke after receiving TOCCT with education.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will use a sample of convenience between the ages of 18-75 years. Forty patients with stroke from the departments of physical medicine and rehabilitation, North Okkalapa General Hospital, East General Hospital and National Rehabilitation Hospital, Yangon, Myanmar will participate in this study. The sample size was calculated using the mean value of gait speed from the previous study. Probability of type I error, apha value at 0.05 and power of 0.80 were set.

All participants will be explained about details of the study and the interventions. After that, they will be asked to sign on the written consent approving by the committee of the institution prior to participate in study. All participants will be randomly allocated the participants into the experimental (TOCCT with MI) or the control (TOCCT with health education) groups. All participants will be screened following the criteria and will be collected the demographic data.

All outcome measures will be assessed by the therapist who have been trained the outcome measures of the study. As the primary outcome measurements, spatio-temporal variables will be measured by using two dimensional motion analysis method. The protocol of this method was proved to be valid and reliability from previous pilot study. For functional gait variables, six-minute walk test will be assessed for determining walking endurance, step test will be assessed for dynamic balance, and Timed Up and Go (TUG) test will be assessed for mobility function.

As the secondary outcome measure, the strength of hip flexor, hip extensor, knee flexor, knee extensor, ankle dorsiflexor, and ankle plantarflexor muscles will be assessed by using hand-held dynamometer. Muscle spasticity will be assessed by using the Modified Ashworth Scale (MAS). The outcome measures will be assessed at the baseline, after 2 weeks and 4 weeks intervention. For the safety, the therapist will measure blood pressure, pulse rate and fatigue level in the assessments, just before the training, and rest period during the training program.

Both groups will receive the same 65 minutes structured progressive TOCCT and will receive 25 minutes of MI training for the experimental group and 25 minutes of health education for the control group. So, total training duration will be 90 minutes. Intervention program will provide 3 times a week over a period of 4 weeks.

Descriptive statistic will be used for analyze the demographic and baseline characteristics of the participants. To clarify whether the data are normally distributed, the Kolmogorov Smirnov Goodness of Fit test will be used. If data are normally distributed, two-way mixed repeated measure ANOVA will be used. If the data are not normally distributed, Friedman test will be used to compare the mean differences of the spatio-temporal measures, 6 minutes walk test, step test, TUG test, muscle strength test and muscle spasticity test. The significant level is set at p < 0.05.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Myanmar
      • Yangon, Myanmar, 11012
        • University of Medical Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • First stroke and paresis on unilateral side of the body
  • Age 18 - 75 years
  • Post-stroke duration 3 - 12 months
  • Middle cerebral artery (MCA) involvement
  • Ability to walk at least 10 meters with or without using assistance
  • Functional Ambulation Category (FAC) more than or equal to 3
  • Mini Mental State Examination (MMSE) more than or equal to 24
  • National Institutes of Health Stroke Scale (NIHSS) lessor than 14
  • MI ability by the Kinesthetic and Visual Imagery Questionnaire (KVIQ-10) more than or equal to 3

Exclusion Criteria:

  • Unstable cardiopulmonary problems
  • Other neurological conditions such as Parkinson's disease, Alzheimer's disease, or epilepsy
  • Orthopedic and rheumatologic disorders with weight bearing pain
  • Unable to communicate or unable to follow commands
  • Serious cardiac conditions
  • Patients with unilateral spatial neglect
  • Patients with ataxic movement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
The experimental group will receive training programs of Motor imagery (MI) for 25 minutes and Task-Oriented Circuit Class Training (TOCCT) for 65 minutes. Overall duration of program session will be 90 minutes. Training for 3 times a week over duration of 4 weeks.
Procedure: Motor imagery
Motor imagery (MI) will be trained for the individuals by imagination of the movement. Program of MI includes 1) body relaxation and awareness 2) visual imagery 3) kinesthetic imagery and 4) refocusing of body and environment.
Procedure: Task-Oriented Circuit Class Training
Program of Task-Oriented Circuit Class Training (TOCCT) consists of warm up and perform tasks 1) Stepping forward-backward onto block 2) Stepping sideway onto block 3) Heel lifts in standing to strengthen affected planter-flexor muscles 4) Standing with a decreased base and reach for object 5) Standing up from chair, walking a short distance, and returning to chair 6) Symmetrical walking and 7) Walking at fast speed.
Active Comparator: Control group
The control group receives programs of Health education (HE) for 25 minutes and Task-Oriented Circuit Class Training (TOCCT) for 65 minutes. Overall duration will be 90 minutes. They will be trained for 3 times a week over duration of 4 weeks.
Procedure: Task-Oriented Circuit Class Training
Program of Task-Oriented Circuit Class Training (TOCCT) consists of warm up and perform tasks 1) Stepping forward-backward onto block 2) Stepping sideway onto block 3) Heel lifts in standing to strengthen affected planter-flexor muscles 4) Standing with a decreased base and reach for object 5) Standing up from chair, walking a short distance, and returning to chair 6) Symmetrical walking and 7) Walking at fast speed.
Procedure: Health education
Topic of Health education (HE) consists of 1) Changes caused by stroke 2) Complications after stroke 3) Emotional changes after stroke 4) Living at home after stroke 5) High blood pressure and stroke and 6) Preventing recurrent stroke.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Gait Speed at 4 Weeks
Time Frame: 4 weeks after training
Measured by using two dimensional motion analysis
4 weeks after training
Change of Step Length at 4 Weeks
Time Frame: 4 weeks after training
Measured by using two dimensional motion analysis
4 weeks after training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Step Time at 4 Weeks
Time Frame: 4 weeks after training
measured by using two dimensional motion analysis
4 weeks after training
Change of Cadence at 4 Weeks
Time Frame: 4 weeks after training
measured by using two dimensional motion analysis
4 weeks after training
Change of 6-minute Walk Score at 4 Weeks
Time Frame: 4 weeks after training
The changed score measured by using the 6-minute walk test. The higher changed scores mean a better outcome.
4 weeks after training
Change of Number of Step at 4 Weeks
Time Frame: 4 weeks after training
The changed score is measured by using the step test, The higher score means better outcome.
4 weeks after training
Change of Timed Up and Go Score at 4 Weeks
Time Frame: 4 weeks after training
The changed score is measured by using the Timed Up and Go test. The higher of changed score mean a worse outcome.
4 weeks after training
Change of Muscle Strength at 4 Weeks
Time Frame: 4 weeks after training
The change score of muscle strength is measured by the hand-held dynamometer
4 weeks after training
Change of Muscle Tone at 4 Weeks
Time Frame: 4 weeks after training
The change score is measured by using the modified Ashworth Scale for each muscle group, the minimum and maximum scores of muscle tone are 0 and 4, respectively. A higher score of tone means a worse outcome.
4 weeks after training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Study Chair: Sunee Bovonsunthonchai, PhD, Faculty of Physical Therapy, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2018

Primary Completion (Actual)

October 10, 2018

Study Completion (Actual)

January 10, 2019

Study Registration Dates

First Submitted

February 5, 2018

First Submitted That Met QC Criteria

February 12, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU-CIRB 2017/178.1010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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