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

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ClinicalTrials.gov Identifier: NCT03436810
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Mahidol University

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.


Condition or disease Intervention/treatment Phase
Stroke Gait, Hemiplegic Procedure: Motor imagery Procedure: Health education Procedure: Task-Oriented Circuit Class Training Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 11, 2018
Estimated Primary Completion Date : July 10, 2018
Estimated Study Completion Date : January 10, 2019

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: 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.

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.




Primary Outcome Measures :
  1. Change of gait speed (m/sec) at 4 weeks [ Time Frame: 4 weeks after training ]
    Measured by using two dimensional motion analysis


Secondary Outcome Measures :
  1. Change of step length (cm) at 4 weeks [ Time Frame: 4 weeks after training ]
    Measured by using two dimensional motion analysis

  2. Change of step time (s) at 4 weeks [ Time Frame: 4 weeks after training ]
    measured by using two dimensional motion analysis

  3. Change of cadence (steps/min) at 4 weeks [ Time Frame: 4 weeks after training ]
    measured by using two dimensional motion analysis

  4. Change of the 6 minute walk score (score) at 4 weeks [ Time Frame: 4 weeks after training ]
    measured by 6 minute walk test

  5. Change of number of step (number) at 4 weeks [ Time Frame: 4 weeks after training ]
    measured by step test

  6. Change of Timed Up and Go (TUG) score (score) at 4 weeks [ Time Frame: 4 weeks after training ]
    measured by TUG test

  7. Change of muscle strength (N) at 4 weeks [ Time Frame: 4 weeks after training ]
    measured by dynamometer

  8. Change of Muscle tone (score) at 4 weeks [ Time Frame: 4 weeks after training ]
    measured by modified Ashworth Scale



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436810


Contacts
Contact: Nilar Aung, MSc :+959400455074 nilaraun@gmail.com
Contact: Sunee Bovonsunthonchai, PhD 66-89-812-8744 sunee.bov@mahidol.edu

Locations
Myanmar
University of Medical Technology Recruiting
Yangon, Myanmar, 11012
Contact: Nilar Aung, MSc    +959400455074    nilaraun@gmail.com   
Sponsors and Collaborators
Mahidol University
Investigators
Study Chair: Sunee Bovonsunthonchai, PhD Faculty of Physical Therapy, Mahidol University

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT03436810     History of Changes
Other Study ID Numbers: MU-CIRB 2017/178.1010
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018

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

Keywords provided by Mahidol University:
Motor Imagery
Task-Oriented Circuit Class Training
Health Education

Additional relevant MeSH terms:
Stroke
Gait Disorders, Neurologic
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms