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

Primary Purpose

Stroke, Gait, Hemiplegic

Status
Completed
Phase
Not Applicable
Locations
Myanmar
Study Type
Interventional
Intervention
Motor imagery
Health education
Task-Oriented Circuit Class Training
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Motor Imagery, Task-Oriented Circuit Class Training, Health Education

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Medical Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change of Gait Speed at 4 Weeks
Measured by using two dimensional motion analysis
Change of Step Length at 4 Weeks
Measured by using two dimensional motion analysis

Secondary Outcome Measures

Change of Step Time at 4 Weeks
measured by using two dimensional motion analysis
Change of Cadence at 4 Weeks
measured by using two dimensional motion analysis
Change of 6-minute Walk Score at 4 Weeks
The changed score measured by using the 6-minute walk test. The higher changed scores mean a better outcome.
Change of Number of Step at 4 Weeks
The changed score is measured by using the step test, The higher score means better outcome.
Change of Timed Up and Go Score at 4 Weeks
The changed score is measured by using the Timed Up and Go test. The higher of changed score mean a worse outcome.
Change of Muscle Strength at 4 Weeks
The change score of muscle strength is measured by the hand-held dynamometer
Change of Muscle Tone at 4 Weeks
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.

Full Information

First Posted
February 5, 2018
Last Updated
March 2, 2021
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT03436810
Brief Title
Effect of Structured Progressive Task-Oriented Circuit Class Training With Motor Imagery on Gait in Stroke
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 11, 2018 (Actual)
Primary Completion Date
October 10, 2018 (Actual)
Study Completion Date
January 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Gait, Hemiplegic
Keywords
Motor Imagery, Task-Oriented Circuit Class Training, Health Education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Motor imagery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Health education
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Task-Oriented Circuit Class Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Gait Speed at 4 Weeks
Description
Measured by using two dimensional motion analysis
Time Frame
4 weeks after training
Title
Change of Step Length at 4 Weeks
Description
Measured by using two dimensional motion analysis
Time Frame
4 weeks after training
Secondary Outcome Measure Information:
Title
Change of Step Time at 4 Weeks
Description
measured by using two dimensional motion analysis
Time Frame
4 weeks after training
Title
Change of Cadence at 4 Weeks
Description
measured by using two dimensional motion analysis
Time Frame
4 weeks after training
Title
Change of 6-minute Walk Score at 4 Weeks
Description
The changed score measured by using the 6-minute walk test. The higher changed scores mean a better outcome.
Time Frame
4 weeks after training
Title
Change of Number of Step at 4 Weeks
Description
The changed score is measured by using the step test, The higher score means better outcome.
Time Frame
4 weeks after training
Title
Change of Timed Up and Go Score at 4 Weeks
Description
The changed score is measured by using the Timed Up and Go test. The higher of changed score mean a worse outcome.
Time Frame
4 weeks after training
Title
Change of Muscle Strength at 4 Weeks
Description
The change score of muscle strength is measured by the hand-held dynamometer
Time Frame
4 weeks after training
Title
Change of Muscle Tone at 4 Weeks
Description
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.
Time Frame
4 weeks after training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunee Bovonsunthonchai, PhD
Organizational Affiliation
Faculty of Physical Therapy, Mahidol University
Official's Role
Study Chair
Facility Information:
Facility Name
University of Medical Technology
City
Yangon
ZIP/Postal Code
11012
Country
Myanmar

12. IPD Sharing Statement

Plan to Share IPD
No
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Effect of Structured Progressive Task-Oriented Circuit Class Training With Motor Imagery on Gait in Stroke

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