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

• Sponsor: Mahidol University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03436810
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 12
• Patients Per Site Per Month: 3.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Gait, Hemiplegic	Procedure: Motor imagery; Procedure: Health education; Procedure: Task-Oriented Circuit Class Training	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel AssignmentParallel 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: Jan 11, 2018
• Actual Primary Completion Date: Oct 10, 2018
• Actual Study Completion Date: Jan 10, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change of Gait Speed at 4 Weeks [4 weeks after training]

   Measured by using two dimensional motion analysis

2. Change of Step Length at 4 Weeks [4 weeks after training]

   Measured by using two dimensional motion analysis

Secondary Outcome Measures

1. Change of Step Time at 4 Weeks [4 weeks after training]

   measured by using two dimensional motion analysis

2. Change of Cadence at 4 Weeks [4 weeks after training]

   measured by using two dimensional motion analysis

3. Change of 6-minute Walk Score at 4 Weeks [4 weeks after training]

   The changed score measured by using the 6-minute walk test. The higher changed scores mean a better outcome.

4. Change of Number of Step at 4 Weeks [4 weeks after training]

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

5. Change of Timed Up and Go Score at 4 Weeks [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.

6. Change of Muscle Strength at 4 Weeks [4 weeks after training]

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

7. Change of Muscle Tone at 4 Weeks [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Medical Technology	Yangon		Myanmar	11012

Sponsors and Collaborators

• Mahidol University

Investigators

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

Study Documents (Full-Text)

• Study Protocol - Jan 18, 2017
• Statistical Analysis Plan - Jan 18, 2017

More Information

Publications

• Balasubramanian CK, Neptune RR, Kautz SA. Variability in spatiotemporal step characteristics and its relationship to walking performance post-stroke. Gait Posture. 2009 Apr;29(3):408-14. doi: 10.1016/j.gaitpost.2008.10.061. Epub 2008 Dec 3.
• Cicinelli P, Marconi B, Zaccagnini M, Pasqualetti P, Filippi MM, Rossini PM. Imagery-induced cortical excitability changes in stroke: a transcranial magnetic stimulation study. Cereb Cortex. 2006 Feb;16(2):247-53. Epub 2005 May 4.
• Kim JS, Oh DW, Kim SY, Choi JD. Visual and kinesthetic locomotor imagery training integrated with auditory step rhythm for walking performance of patients with chronic stroke. Clin Rehabil. 2011 Feb;25(2):134-45. doi: 10.1177/0269215510380822. Epub 2010 Oct 13.
• Macko RF, Ivey FM, Forrester LW. Task-oriented aerobic exercise in chronic hemiparetic stroke: training protocols and treatment effects. Top Stroke Rehabil. 2005 Winter;12(1):45-57. Review.
• Thrift AG, Thayabaranathan T, Howard G, Howard VJ, Rothwell PM, Feigin VL, Norrving B, Donnan GA, Cadilhac DA. Global stroke statistics. Int J Stroke. 2017 Jan;12(1):13-32. doi: 10.1177/1747493016676285. Epub 2016 Oct 28. Review.
• Yang YR, Wang RY, Lin KH, Chu MY, Chan RC. Task-oriented progressive resistance strength training improves muscle strength and functional performance in individuals with stroke. Clin Rehabil. 2006 Oct;20(10):860-70.

• Responsible Party: Mahidol University
• ClinicalTrials.gov Identifier: NCT03436810
• Other Study ID Numbers: MU-CIRB 2017/178.1010
• First Posted: Feb 19, 2018
• Last Update Posted: Mar 25, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Experimental Group	Control Group
Arm/Group 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. 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.	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.
Period Title: Overall Study
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Experimental Group	Control Group	Total
Arm/Group 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. 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.	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.	Total of all reporting groups
Overall Participants	20	20	40
Age (year) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [year]	49.90 (11.59)	55.55 (10.74)	52.48 (11.46)
Sex: Female, Male (Count of Participants)
Female	5 25%	9 45%	14 35%
Male	15 75%	11 55%	26 65%
Race/Ethnicity, Customized (participants) [Number]
Asian	20 100%	20 100%	40 100%
Region of Enrollment (participants) [Number]
Myanmar	20 100%	20 100%	40 100%
Stroke characteristics (Count of Participants)
Ischemic stroke	12 60%	14 70%	26 65%
Hemorrhage stroke	8 40%	6 30%	14 35%
Right-sided stroke	10 50%	12 60%	22 55%
Left-sided stroke	10 50%	8 40%	18 45%
Mild	12 60%	14 70%	26 65%
Moderate	8 40%	6 30%	14 35%

Outcome Measures

1. Primary Outcome

Title	Change of Gait Speed at 4 Weeks
Description	Measured by using two dimensional motion analysis
Time Frame	4 weeks after training

Outcome Measure Data

Analysis Population Description

40

Arm/Group Title	Experimental Group	Control Group
Arm/Group 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. 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.	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.
Measure Participants	20	20
Mean (Standard Deviation) [meter per second]	0.78 (0.21)	0.58 (0.27)

2. Primary Outcome

Title	Change of Step Length at 4 Weeks
Description	Measured by using two dimensional motion analysis
Time Frame	4 weeks after training

Outcome Measure Data

Analysis Population Description

40

Arm/Group Title	Experimental Group	Control Group
Arm/Group 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. 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.	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.
Measure Participants	20	20
affected limb	49.76 (6.99)	42.07 (11.46)
unaffected limb	47.78 (8.37)	41.45 (12.17)

3. Secondary Outcome

Title	Change of Step Time at 4 Weeks
Description	measured by using two dimensional motion analysis
Time Frame	4 weeks after training

Outcome Measure Data

Analysis Population Description

40

Arm/Group Title	Experimental Group	Control Group
Arm/Group 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. 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.	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.
Measure Participants	20	20
affected limb	0.72	0.83
unaffected limb	0.53	0.70

4. Secondary Outcome

Title	Change of Cadence at 4 Weeks
Description	measured by using two dimensional motion analysis
Time Frame	4 weeks after training

Outcome Measure Data

Analysis Population Description

40

Arm/Group Title	Experimental Group	Control Group
Arm/Group 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. 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.	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.
Measure Participants	20	20
Mean (Standard Deviation) [steps per minute]	94.13 (17.09)	78.88 (26.35)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

40

Arm/Group Title	Experimental Group	Control Group
Arm/Group 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. 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.	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.
Measure Participants	20	20
Median (Inter-Quartile Range) [meter]	246.50	152.50

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

40

Arm/Group Title	Experimental Group	Control Group
Arm/Group 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. 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.	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.
Measure Participants	20	20
Mean (Standard Deviation) [number of steps]	12.60 (2.54)	10.65 (2.78)

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

40

Arm/Group Title	Experimental Group	Control Group
Arm/Group 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. 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.	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.
Measure Participants	20	20
Median (Inter-Quartile Range) [second]	11.25	14.01

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

40

Arm/Group Title	Experimental Group	Control Group
Arm/Group 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. 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.	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.
Measure Participants	20	20
hip flexor	3.30	2.90
hip extensor	3.30	3.00
knee flexor	3.35	2.70
knee extensor	3.75	3.00
ankle dorsiflexor	2.55	2.60
ankle planterflexor	2.80	2.50

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

40

Arm/Group Title	Experimental Group	Control Group
Arm/Group 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. 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.	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.
Measure Participants	20	20
knee flexor	1.00	1.00
ankle planterflexor	1.00	1.00

Adverse Events

Time Frame	The adverse event data were collected for every participant over the 4 weeks duration of the training program.
Adverse Event Reporting Description	Severe adverse event means falls or incidents leading to the injury requiring hospital or general practitioner visit.
Arm/Group Title	Control Group		Experimental Group
Arm/Group Description	The control group received 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 were trained for 3 times a week over duration of 4 weeks. Health education: Topic of Health education (HE) consisted 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) consisted 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		The experimental group received training programs of Motor imagery (MI) for 25 minutes and Task-Oriented Circuit Class Training (TOCCT) for 65 minutes. Training for 3 times a week over duration of 4 weeks. Motor imagery: Motor imagery (MI) was 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) consisted 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
All Cause Mortality
	Control Group		Experimental Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Control Group		Experimental Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Control Group		Experimental Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.