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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03436810
Enrollment
40
Registered
2018-02-19
Start date
2018-01-11
Completion date
2019-01-10
Last updated
2021-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gait, Hemiplegic, Stroke

Keywords

Motor Imagery, Task-Oriented Circuit Class Training, Health Education

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.

Interventions

PROCEDUREMotor 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.

PROCEDUREHealth 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.

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.

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Parallel Assignment

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of Gait Speed at 4 Weeks4 weeks after trainingMeasured by using two dimensional motion analysis
Change of Step Length at 4 Weeks4 weeks after trainingMeasured by using two dimensional motion analysis

Secondary

MeasureTime frameDescription
Change of Step Time at 4 Weeks4 weeks after trainingmeasured by using two dimensional motion analysis
Change of Cadence at 4 Weeks4 weeks after trainingmeasured by using two dimensional motion analysis
Change of 6-minute Walk Score at 4 Weeks4 weeks after trainingThe 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 Weeks4 weeks after trainingThe changed score is measured by using the step test, The higher score means better outcome.
Change of Timed Up and Go Score at 4 Weeks4 weeks after trainingThe 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 Weeks4 weeks after trainingThe change score of muscle strength is measured by the hand-held dynamometer
Change of Muscle Tone at 4 Weeks4 weeks after trainingThe 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.

Countries

Burma

Participant flow

Pre-assignment details

The potential participants were screened according to the selection criteria of the study. The eligible participants were explained about the details of the study and the interventions. After that, the processes of taking informed consent were done. There was no participant who was excluded after enrollment.

Participants by arm

ArmCount
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. 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. 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.
20
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. 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. 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.
20
Total40

Baseline characteristics

CharacteristicControl GroupTotalExperimental Group
Age, Continuous55.55 year
STANDARD_DEVIATION 10.74
52.48 year
STANDARD_DEVIATION 11.46
49.90 year
STANDARD_DEVIATION 11.59
Race/Ethnicity, Customized
Asian
20 participants40 participants20 participants
Region of Enrollment
Myanmar
20 participants40 participants20 participants
Sex: Female, Male
Female
9 Participants14 Participants5 Participants
Sex: Female, Male
Male
11 Participants26 Participants15 Participants
Stroke characteristics
Hemorrhage stroke
6 Participants14 Participants8 Participants
Stroke characteristics
Ischemic stroke
14 Participants26 Participants12 Participants
Stroke characteristics
Left-sided stroke
8 Participants18 Participants10 Participants
Stroke characteristics
Mild
14 Participants26 Participants12 Participants
Stroke characteristics
Moderate
6 Participants14 Participants8 Participants
Stroke characteristics
Right-sided stroke
12 Participants22 Participants10 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 20
other
Total, other adverse events
0 / 200 / 20
serious
Total, serious adverse events
0 / 200 / 20

Outcome results

Primary

Change of Gait Speed at 4 Weeks

Measured by using two dimensional motion analysis

Time frame: 4 weeks after training

Population: 40

ArmMeasureValue (MEAN)Dispersion
Experimental GroupChange of Gait Speed at 4 Weeks0.78 meter per secondStandard Deviation 0.21
Control GroupChange of Gait Speed at 4 Weeks0.58 meter per secondStandard Deviation 0.27
Primary

Change of Step Length at 4 Weeks

Measured by using two dimensional motion analysis

Time frame: 4 weeks after training

Population: 40

ArmMeasureGroupValue (MEAN)Dispersion
Experimental GroupChange of Step Length at 4 Weeksaffected limb49.76 centimeterStandard Deviation 6.99
Experimental GroupChange of Step Length at 4 Weeksunaffected limb47.78 centimeterStandard Deviation 8.37
Control GroupChange of Step Length at 4 Weeksaffected limb42.07 centimeterStandard Deviation 11.46
Control GroupChange of Step Length at 4 Weeksunaffected limb41.45 centimeterStandard Deviation 12.17
Secondary

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.

Time frame: 4 weeks after training

Population: 40

ArmMeasureValue (MEDIAN)
Experimental GroupChange of 6-minute Walk Score at 4 Weeks246.50 meter
Control GroupChange of 6-minute Walk Score at 4 Weeks152.50 meter
Secondary

Change of Cadence at 4 Weeks

measured by using two dimensional motion analysis

Time frame: 4 weeks after training

Population: 40

ArmMeasureValue (MEAN)Dispersion
Experimental GroupChange of Cadence at 4 Weeks94.13 steps per minuteStandard Deviation 17.09
Control GroupChange of Cadence at 4 Weeks78.88 steps per minuteStandard Deviation 26.35
Secondary

Change of Muscle Strength at 4 Weeks

The change score of muscle strength is measured by the hand-held dynamometer

Time frame: 4 weeks after training

Population: 40

ArmMeasureGroupValue (MEDIAN)
Experimental GroupChange of Muscle Strength at 4 Weekship flexor3.30 kilogram
Experimental GroupChange of Muscle Strength at 4 Weekship extensor3.30 kilogram
Experimental GroupChange of Muscle Strength at 4 Weeksknee flexor3.35 kilogram
Experimental GroupChange of Muscle Strength at 4 Weeksknee extensor3.75 kilogram
Experimental GroupChange of Muscle Strength at 4 Weeksankle dorsiflexor2.55 kilogram
Experimental GroupChange of Muscle Strength at 4 Weeksankle planterflexor2.80 kilogram
Control GroupChange of Muscle Strength at 4 Weeksankle dorsiflexor2.60 kilogram
Control GroupChange of Muscle Strength at 4 Weekship flexor2.90 kilogram
Control GroupChange of Muscle Strength at 4 Weeksknee extensor3.00 kilogram
Control GroupChange of Muscle Strength at 4 Weekship extensor3.00 kilogram
Control GroupChange of Muscle Strength at 4 Weeksankle planterflexor2.50 kilogram
Control GroupChange of Muscle Strength at 4 Weeksknee flexor2.70 kilogram
Secondary

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.

Time frame: 4 weeks after training

Population: 40

ArmMeasureGroupValue (MEDIAN)
Experimental GroupChange of Muscle Tone at 4 Weeksknee flexor1.00 score
Experimental GroupChange of Muscle Tone at 4 Weeksankle planterflexor1.00 score
Control GroupChange of Muscle Tone at 4 Weeksknee flexor1.00 score
Control GroupChange of Muscle Tone at 4 Weeksankle planterflexor1.00 score
Secondary

Change of Number of Step at 4 Weeks

The changed score is measured by using the step test, The higher score means better outcome.

Time frame: 4 weeks after training

Population: 40

ArmMeasureValue (MEAN)Dispersion
Experimental GroupChange of Number of Step at 4 Weeks12.60 number of stepsStandard Deviation 2.54
Control GroupChange of Number of Step at 4 Weeks10.65 number of stepsStandard Deviation 2.78
Secondary

Change of Step Time at 4 Weeks

measured by using two dimensional motion analysis

Time frame: 4 weeks after training

Population: 40

ArmMeasureGroupValue (MEDIAN)
Experimental GroupChange of Step Time at 4 Weeksaffected limb0.72 second
Experimental GroupChange of Step Time at 4 Weeksunaffected limb0.53 second
Control GroupChange of Step Time at 4 Weeksaffected limb0.83 second
Control GroupChange of Step Time at 4 Weeksunaffected limb0.70 second
Secondary

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.

Time frame: 4 weeks after training

Population: 40

ArmMeasureValue (MEDIAN)
Experimental GroupChange of Timed Up and Go Score at 4 Weeks11.25 second
Control GroupChange of Timed Up and Go Score at 4 Weeks14.01 second

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026