StrokeNCT03436810
Effect of Structured Progressive Task-Oriented Circuit Class Training With Motor Imagery on Gait in Stroke
A study testing Motor imagery, Health education and Task-Oriented Circuit Class Training in people with Stroke and Gait, Hemiplegic, run by Mahidol University at 1 site in Burma.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Gait, Hemiplegic
- What is being tested?
- Motor imagery, Health education and Task-Oriented Circuit Class Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBurma
- Study dates
- 11 Jan 2018to 10 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Stroke, Gait, Hemiplegic
- Being tested
- Motor imagery, Health education, Task-Oriented Circuit Class Training
- Keywords
- Motor Imagery, Task-Oriented Circuit Class Training, Health Education
- Medical subject headings
- Stroke, Gait Disorders, Neurologic, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor imageryProcedure or surgery
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.
Health educationProcedure or surgery
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 TrainingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Procedure: Motor imagery; Procedure: Task-Oriented Circuit Class Training |
| Control group | Active comparator | 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. Receives: Procedure: Health education; Procedure: Task-Oriented Circuit Class Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Gait Speed at 4 Weeks
Measured by using two dimensional motion analysis
Measured: 4 weeks after training
Change of Step Length at 4 Weeks
Measured by using two dimensional motion analysis
Measured: 4 weeks after training
Secondary outcomes (7)
Change of Step Time at 4 Weeks
measured by using two dimensional motion analysis
Measured: 4 weeks after training
Change of Cadence at 4 Weeks
measured by using two dimensional motion analysis
Measured: 4 weeks after training
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.
Measured: 4 weeks after training
Change of Number of Step at 4 Weeks
The changed score is measured by using the step test, The higher score means better outcome.
Measured: 4 weeks after training
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.
Measured: 4 weeks after training
Change of Muscle Strength at 4 Weeks
The change score of muscle strength is measured by the hand-held dynamometer
Measured: 4 weeks after training
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.
Measured: 4 weeks after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start11 Jan 2018
- Primary completion10 Oct 2018
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunee Bovonsunthonchai, PhD, Study chair, Faculty of Physical Therapy, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436810
- Sponsor's protocol ID
- MU-CIRB 2017/178.1010
- Status last verified
- Mar 2021
- First submitted
- 5 Feb 2018
- Last updated
- 25 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27794138Macko 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. doi: 10.1310/PJQN-KAN9-TTVY-HYQH.
PubMed 15736000Yang 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. doi: 10.1177/0269215506070701.
PubMed 17008338Cicinelli 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. doi: 10.1093/cercor/bhi103. Epub 2005 May 4.
PubMed 15872152Kim 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.
PubMed 20943715Balasubramanian 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.
PubMed 19056272Billinger SA, Arena R, Bernhardt J, Eng JJ, Franklin BA, Johnson CM, MacKay-Lyons M, Macko RF, Mead GE, Roth EJ, Shaughnessy M, Tang A; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Lifestyle and Cardiometabolic Health; Council on Epidemiology and Prevention; Council on Clinical Cardiology. Physical activity and exercise recommendations for stroke survivors: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Aug;45(8):2532-53. doi: 10.1161/STR.0000000000000022. Epub 2014 May 20.
PubMed 24846875Brandstater ME, de Bruin H, Gowland C, Clark BM. Hemiplegic gait: analysis of temporal variables. Arch Phys Med Rehabil. 1983 Dec;64(12):583-7.
PubMed 6661021Jorgensen L, Crabtree NJ, Reeve J, Jacobsen BK. Ambulatory level and asymmetrical weight bearing after stroke affects bone loss in the upper and lower part of the femoral neck differently: bone adaptation after decreased mechanical loading. Bone. 2000 Nov;27(5):701-7. doi: 10.1016/s8756-3282(00)00374-4.
PubMed 11062359Verma R, Arya KN, Garg RK, Singh T. Task-oriented circuit class training program with motor imagery for gait rehabilitation in poststroke patients: a randomized controlled trial. Top Stroke Rehabil. 2011 Oct;18 Suppl 1:620-32. doi: 10.1310/tsr18s01-620.
PubMed 22120031English C, Hillier SL, Lynch EA. Circuit class therapy for improving mobility after stroke. Cochrane Database Syst Rev. 2017 Jun 2;6(6):CD007513. doi: 10.1002/14651858.CD007513.pub3.
PubMed 28573757Guillot A, Collet C. Contribution from neurophysiological and psychological methods to the study of motor imagery. Brain Res Brain Res Rev. 2005 Dec 15;50(2):387-97. doi: 10.1016/j.brainresrev.2005.09.004. Epub 2005 Nov 3.
PubMed 16271398Malouin F, Richards CL, Jackson PL, Dumas F, Doyon J. Brain activations during motor imagery of locomotor-related tasks: a PET study. Hum Brain Mapp. 2003 May;19(1):47-62. doi: 10.1002/hbm.10103.
PubMed 12731103Dunsky A, Dickstein R, Marcovitz E, Levy S, Deutsch JE. Home-based motor imagery training for gait rehabilitation of people with chronic poststroke hemiparesis. Arch Phys Med Rehabil. 2008 Aug;89(8):1580-8. doi: 10.1016/j.apmr.2007.12.039.
PubMed 18674992Zimmermann-Schlatter A, Schuster C, Puhan MA, Siekierka E, Steurer J. Efficacy of motor imagery in post-stroke rehabilitation: a systematic review. J Neuroeng Rehabil. 2008 Mar 14;5:8. doi: 10.1186/1743-0003-5-8.
PubMed 18341687
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03436810
- Acronym / sponsor ID
- MU-CIRB 2017/178.1010
- Conditions
- Stroke, Gait, Hemiplegic
- Keywords
- Motor Imagery, Task-Oriented Circuit Class Training, Health Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Posted 25 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Motor imagery, Procedure: Task-Oriented Circuit Class TrainingThe 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. |
| Control group | Active comparator | Procedure: Health education, Procedure: Task-Oriented Circuit Class TrainingThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor imageryMotor 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 or surgery | Experimental group |
| Health educationTopic 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 or surgery | Control group |
| Task-Oriented Circuit Class TrainingProgram 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. | Procedure or surgery | Control group, Experimental group |
Primary outcome
Change of Gait Speed at 4 Weeks
Time frame: 4 weeks after training
Measured by using two dimensional motion analysis
Change of Step Length at 4 Weeks
Time frame: 4 weeks after training
Measured by using two dimensional motion analysis
7 secondary outcomes
Change of Step Time at 4 Weeks
Time frame: 4 weeks after training
Change of Cadence at 4 Weeks
Time frame: 4 weeks after training
Change of 6-minute Walk Score at 4 Weeks
Time frame: 4 weeks after training
Change of Number of Step at 4 Weeks
Time frame: 4 weeks after training
Change of Timed Up and Go Score at 4 Weeks
Time frame: 4 weeks after training
Change of Muscle Strength at 4 Weeks
Time frame: 4 weeks after training
Change of Muscle Tone at 4 Weeks
Time frame: 4 weeks after training
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27794138Thrift 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.
- Background: PubMed 15736000Macko 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. doi: 10.1310/PJQN-KAN9-TTVY-HYQH.
- Background: PubMed 17008338Yang 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. doi: 10.1177/0269215506070701.
- Background: PubMed 15872152Cicinelli 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. doi: 10.1093/cercor/bhi103. Epub 2005 May 4.
- Background: PubMed 20943715Kim 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.
- Background: PubMed 19056272Balasubramanian 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.
- Results publication: PubMed 24846875Billinger SA, Arena R, Bernhardt J, Eng JJ, Franklin BA, Johnson CM, MacKay-Lyons M, Macko RF, Mead GE, Roth EJ, Shaughnessy M, Tang A; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Lifestyle and Cardiometabolic Health; Council on Epidemiology and Prevention; Council on Clinical Cardiology. Physical activity and exercise recommendations for stroke survivors: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Aug;45(8):2532-53. doi: 10.1161/STR.0000000000000022. Epub 2014 May 20.
- Results publication: PubMed 6661021Brandstater ME, de Bruin H, Gowland C, Clark BM. Hemiplegic gait: analysis of temporal variables. Arch Phys Med Rehabil. 1983 Dec;64(12):583-7.
- Results publication: PubMed 11062359Jorgensen L, Crabtree NJ, Reeve J, Jacobsen BK. Ambulatory level and asymmetrical weight bearing after stroke affects bone loss in the upper and lower part of the femoral neck differently: bone adaptation after decreased mechanical loading. Bone. 2000 Nov;27(5):701-7. doi: 10.1016/s8756-3282(00)00374-4.
- Results publication: PubMed 22120031Verma R, Arya KN, Garg RK, Singh T. Task-oriented circuit class training program with motor imagery for gait rehabilitation in poststroke patients: a randomized controlled trial. Top Stroke Rehabil. 2011 Oct;18 Suppl 1:620-32. doi: 10.1310/tsr18s01-620.
- Results publication: PubMed 28573757English C, Hillier SL, Lynch EA. Circuit class therapy for improving mobility after stroke. Cochrane Database Syst Rev. 2017 Jun 2;6(6):CD007513. doi: 10.1002/14651858.CD007513.pub3.
- Results publication: PubMed 16271398Guillot A, Collet C. Contribution from neurophysiological and psychological methods to the study of motor imagery. Brain Res Brain Res Rev. 2005 Dec 15;50(2):387-97. doi: 10.1016/j.brainresrev.2005.09.004. Epub 2005 Nov 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunee Bovonsunthonchai, PhD study chair
Faculty of Physical Therapy, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor imagery, Health education and Task-Oriented Circuit Class Training in people with Stroke and Gait, Hemiplegic, run by Mahidol University at 1 site in Burma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burma. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Gait Speed at 4 Weeks (time frame: 4 weeks after training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03436810, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021.