Clinical trial NCT03436810: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Gait, Hemiplegic
Keywords: Motor Imagery
Task-Oriented Circuit Class Training
Health Education
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of Gait Speed at 4 Weeks
timeFrame: 4 weeks after training
measure: Change of Step Length at 4 Weeks
timeFrame: 4 weeks after training
Secondary outcomes:
measure: Change of Step Time at 4 Weeks
timeFrame: 4 weeks after training
measure: Change of Cadence at 4 Weeks
timeFrame: 4 weeks after training
measure: Change of 6-minute Walk Score at 4 Weeks
timeFrame: 4 weeks after training
measure: Change of Number of Step at 4 Weeks
timeFrame: 4 weeks after training
measure: Change of Timed Up and Go Score at 4 Weeks
timeFrame: 4 weeks after training
measure: Change of Muscle Strength at 4 Weeks
timeFrame: 4 weeks after training
measure: Change of Muscle Tone at 4 Weeks
timeFrame: 4 weeks after training
Other outcomes:
Locations:
city: Yangon
country: Myanmar
facility: University of Medical Technology
Study officials:
affiliation: Faculty of Physical Therapy, Mahidol University
name: Sunee Bovonsunthonchai, PhD
role: STUDY_CHAIR
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