StrokeNCT02480140
Self-regulated Constraint-induced Movement Therapy in Subacute Stroke Patients
A study testing Self-regulated constraint-induced movement therapy, Constraint-induced movement therapy and Conventional occupational therapy in people with Stroke, run by University of Western Sydney at 2 sites in Hong Kong.
Trial summary
Emerging research suggests the use of self-regulation (SR) strategies at improving functional regain in patients with brain injury. SR is proposed to produce an added effect to the effective constraint-induced movement therapy (CIMT). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Self-regulated constraint-induced movement therapy, Constraint-induced movement therapy and Conventional occupational therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesHong Kong
- Study dates
- Sep 2008to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sustained an ischemic type stroke with lesion in the primary or motor cortical areas resulting in hemiplegia,
- had stroke onset of less than 3 months,
- were aged above 60, and
- had 10 degree active extension in metacarpophalangeal joint and interphalangeal joint, 20 degree active extension of wrist joint
Who cannot join
- had excessive spasticity in the affected limb, as defined by a score of 2 or more on the Modified Ashworth Scale,
- had excessive pain in the affected limb, as defined by a score 4 or more using a Visual Analog Scale,
- had a score below 19 on the Mini-Mental Status Examination (MMSE), and
- had diagnosed of depression according to Diagnostic and Statistical Manual-IV (DSM-IV) criteria
Trial locations and contacts
2 sites in 1 country.
About this study
Emerging research suggests the use of self-regulation (SR) strategies at improving functional regain in patients with brain injury. SR is proposed to produce an added effect to the effective constraint-induced movement therapy (CIMT). This study aimed to examine the efficacy of a self-regulated CIMT program (SR-CIMT) for function regain of patients with subacute stroke. It was hypothesized that participants receiving the combined treatment (SR and CIMT) would have a better functional regain.
Read the detailed description
Background - Emerging research suggests the use of self-regulation (SR) strategies at improving functional regain in patients with brain injury. SR is proposed to produce an added effect to the effective constraint-induced movement therapy (CIMT).
Objective - This study aimed to examine the efficacy of a self-regulated CIMT program (SR-CIMT) for function regain of patients with sub-acute stroke.
Methods - Seventy-six patients were randomly assigned to the self-regulated constraint-induced movement therapy (SR-CIMT; n=25), constraint-induced movement therapy (CIMT; n=27) or conventional functional rehabilitation (control; n=24) groups, and completed the trial.
The SR-CIMT intervention was two-week therapist-guided training using the SR strategy to reflect on the relearning of functional tasks with CIMT. Outcome measurements were for upper limb function (Action Research Arm Test, ARAT, Fugl-Meyer Assessment, FMA), daily task performance (Lawton Instrumental Activities of Daily Living Scale, Lawton IADL) and self-perceived functional ability (Motor Activity Log, MAL) at pre and post intervention intervals, and at one month follow up.
- Conditions
- Stroke
- Being tested
- Self-regulated constraint-induced movement therapy, Constraint-induced movement therapy, Conventional occupational therapy
- Keywords
- Self-regulation, Constraint-induced movement therapy, Stroke, Functional recovery, Randomized controlled trial
- Medical subject headings
- Stroke, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-regulated constraint-induced movement therapyOther
There were 10 tasks to practice in total, they included fold laundry, put clothes on hanger, brush teeth, dress upper garment, dress lower garment in week one; and use telephone, prepare a cup of tea, sweep floor, wash towel, wash dishes in week two. In the 4 hours when the participants had their non-hemiplegic arm in the restrain, they received one hour therapist-guided training using SR strategy on task relearning as described above. Therefore, all participants received 10 one-hour therapist-guided training sessions (daily on weekdays, total two weeks). The intervention was delivered by occupational therapist. For the rest of the 3 hours in the restrain, the participants' wearing of the restrain was monitored by the nursing staff in the ward.
Constraint-induced movement therapyOther
They practised the same 10 tasks as in the SR-CIMT and control groups. The same as the experimental intervention group (SR-CIMT), in the 4 hours when the participants had their non-hemiplegic arm in the restrain, they received one hour therapist-guided training using the strategy on task relearning as described above. Therefore, all participants received 10 one-hour therapist-guided training sessions (daily on weekdays, total two weeks). The intervention was delivered by occupational therapist. For the rest of the 3 hours in the restrain, the participants' wearing of the restrain was monitored by the nursing staff in the ward.
Conventional occupational therapyOther
They practised the same 10 tasks as in the SR-CIMT group described above. They received training for 2 weeks, 5 days a week (therapy days), the same as in the SR-CIMT and CIMT groups.
| Study group | Role | What they receive |
|---|---|---|
| Self-regulated constraint-induced movement therapy | Experimental | Self-regulated constraint-induced movement therapy (SR-CIMT) - participants' non-hemiplegic arm was restrained in a mitt for 4 hours every day, 2 weeks, 5 days a week (therapy days) (CIMT) (the same CIMT protocol as in the CIMT group described under 'comparator/control treatment'); participants were taught using the self-regulation (SR) strategy to relearn the tasks; SR strategy involved participants self reflecting on their abilities and deficits in performing the tasks, identifying problems and solutions in achieving the most independence in the tasks, and then actually carrying out the tasks. Receives: Other: Self-regulated constraint-induced movement therapy |
| Constraint-induced movement therapy | Active comparator | In the constraint-induced movement therapy group (CIMT), participants' non-hemiplegic arm was restrained in a mitt for 4 hours every day, 2 weeks, 5 days a week (therapy days); therapist provided demonstration on the adapted task performance with one arm (the side of participants' hemiplegic arm), and participants to practice the tasks with the unrestrained hemiplegic arm under supervision. Receives: Other: Constraint-induced movement therapy |
| Conventional occupational therapy | Active comparator | It involved therapist to demonstrate the adapted task performance followed by patient's practice under supervision. Receives: Other: Conventional occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Lawton Instrumental Activities of Daily Living Scale after the intervention
Performance assessment on 8 daily tasks
Measured: Baseline and after the intervention (2 weeks)
Change from baseline in Lawton Instrumental Activities of Daily Living Scale at one month after the intervention completed
Performance assessment on 8 daily tasks
Measured: Baseline and one month after the intervention completed (1 month and 2 weeks)
Change from baseline in Action Research Arm Test after the intervention
Performance assessment on arm function
Measured: Baseline and after the intervention (2 weeks)
Change from baseline in Action Research Arm Test at one month after the intervention completed
Performance assessment on arm function
Measured: Baseline and one month after the intervention completed (1 month and 2 weeks)
Change from baseline in Fugl Meyer Assessment, upper extremity motor subsection after the intervention
Performance assessment on arm function
Measured: Baseline and after the intervention (2 weeks)
Change from baseline in Fugl Meyer Assessment, upper extremity motor subsection at one month after the intervention completed
Performance assessment on arm function
Measured: Baseline and one month after the intervention completed (1 month and 2 weeks)
Secondary outcomes (2)
Change from baseline in Motor Activity Log-28 after the intervention
Self-reported assessment on daily function
Measured: Baseline and after the intervention (2 weeks)
Change from baseline in Motor Activity Log-28 at one month after the intervention completed
Self-reported assessment on daily function
Measured: Baseline and one month after the intervention completed (1 month and 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startSep 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Responsible party
- Principal investigator, Karen Liu, University of Western Sydney
- Investigators
- Karen P.Y. Liu, PhD, Principal investigator, University of Western Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480140
- Sponsor's protocol ID
- SR-CIMT
- Status last verified
- Jun 2015
- First submitted
- 18 Jun 2015
- Last updated
- 29 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lam, K., Liu, K., Leung, T., Sum, C., Yue, A. & Mok, V. (2013, 24-26 July). The effectiveness of self-regulated constraint-induced movement therapy for functional regain for people with sub-acute stroke: A randomized controlled trial. Australian Occupational Therapy Journal, 110.
Leung, T., Liu, K.P.Y., Sum, C., Mok, V. & Lum, C. (2010). Self-regulation constraint-induced movement therapy programme for people with subacute stroke. Hong Kong Hospital Authority Rehabilitation Symposium.
Leung, T., Liu, K.P.Y., Sum, C., Mok, V. & Lum, C. (2010). Self-regulation constraint-induced movement therapy programme for people with subacute stroke. Hong Kong Journal of Occupational Therapy,19, A8.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-regulated Constraint-induced Movement Therapy in Subacute Stroke Patients
- ClinicalTrials.gov ID
- NCT02480140
- Acronym / sponsor ID
- SR-CIMT
- Conditions
- Stroke
- Keywords
- Self-regulation, Constraint-induced movement therapy, Stroke, Functional recovery, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of Western SydneyUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Study start
- Sep 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Emerging research suggests the use of self-regulation (SR) strategies at improving functional regain in patients with brain injury. SR is proposed to produce an added effect to the effective constraint-induced movement therapy (CIMT). This study aimed to examine the efficacy of a self-regulated CIMT program (SR-CIMT) for function regain of patients with subacute stroke. It was hypothesized that participants receiving the combined treatment (SR and CIMT) would have a better functional regain.
Detailed description
Background - Emerging research suggests the use of self-regulation (SR) strategies at improving functional regain in patients with brain injury. SR is proposed to produce an added effect to the effective constraint-induced movement therapy (CIMT).
Objective - This study aimed to examine the efficacy of a self-regulated CIMT program (SR-CIMT) for function regain of patients with sub-acute stroke.
Methods - Seventy-six patients were randomly assigned to the self-regulated constraint-induced movement therapy (SR-CIMT; n=25), constraint-induced movement therapy (CIMT; n=27) or conventional functional rehabilitation (control; n=24) groups, and completed the trial.
The SR-CIMT intervention was two-week therapist-guided training using the SR strategy to reflect on the relearning of functional tasks with CIMT. Outcome measurements were for upper limb function (Action Research Arm Test, ARAT, Fugl-Meyer Assessment, FMA), daily task performance (Lawton Instrumental Activities of Daily Living Scale, Lawton IADL) and self-perceived functional ability (Motor Activity Log, MAL) at pre and post intervention intervals, and at one month follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self-regulated constraint-induced movement therapy | Experimental | Other: Self-regulated constraint-induced movement therapySelf-regulated constraint-induced movement therapy (SR-CIMT) - participants' non-hemiplegic arm was restrained in a mitt for 4 hours every day, 2 weeks, 5 days a week (therapy days) (CIMT) (the same CIMT protocol as in the CIMT group described under 'comparator/control treatment'); participants were taught using the self-regulation (SR) strategy to relearn the tasks; SR strategy involved participants self reflecting on their abilities and deficits in performing the tasks, identifying problems and solutions in achieving the most independence in the tasks, and then actually carrying out the tasks. |
| Constraint-induced movement therapy | Active comparator | Other: Constraint-induced movement therapyIn the constraint-induced movement therapy group (CIMT), participants' non-hemiplegic arm was restrained in a mitt for 4 hours every day, 2 weeks, 5 days a week (therapy days); therapist provided demonstration on the adapted task performance with one arm (the side of participants' hemiplegic arm), and participants to practice the tasks with the unrestrained hemiplegic arm under supervision. |
| Conventional occupational therapy | Active comparator | Other: Conventional occupational therapyIt involved therapist to demonstrate the adapted task performance followed by patient's practice under supervision. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- sustained an ischemic type stroke with lesion in the primary or motor cortical areas resulting in hemiplegia,
- had stroke onset of less than 3 months,
- were aged above 60, and
- had 10 degree active extension in metacarpophalangeal joint and interphalangeal joint, 20 degree active extension of wrist joint
Key exclusion criteria (4 listed)
- had excessive spasticity in the affected limb, as defined by a score of 2 or more on the Modified Ashworth Scale,
- had excessive pain in the affected limb, as defined by a score 4 or more using a Visual Analog Scale,
- had a score below 19 on the Mini-Mental Status Examination (MMSE), and
- had diagnosed of depression according to Diagnostic and Statistical Manual-IV (DSM-IV) criteria
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 |
|---|---|---|
| Self-regulated constraint-induced movement therapyThere were 10 tasks to practice in total, they included fold laundry, put clothes on hanger, brush teeth, dress upper garment, dress lower garment in week one; and use telephone, prepare a cup of tea, sweep floor, wash towel, wash dishes in week two. In the 4 hours when the participants had their non-hemiplegic arm in the restrain, they received one hour therapist-guided training using SR strategy on task relearning as described above. Therefore, all participants received 10 one-hour therapist-guided training sessions (daily on weekdays, total two weeks). The intervention was delivered by occupational therapist. For the rest of the 3 hours in the restrain, the participants' wearing of the restrain was monitored by the nursing staff in the ward. | Other | Self-regulated constraint-induced movement therapy |
| Constraint-induced movement therapyThey practised the same 10 tasks as in the SR-CIMT and control groups. The same as the experimental intervention group (SR-CIMT), in the 4 hours when the participants had their non-hemiplegic arm in the restrain, they received one hour therapist-guided training using the strategy on task relearning as described above. Therefore, all participants received 10 one-hour therapist-guided training sessions (daily on weekdays, total two weeks). The intervention was delivered by occupational therapist. For the rest of the 3 hours in the restrain, the participants' wearing of the restrain was monitored by the nursing staff in the ward. | Other | Constraint-induced movement therapy |
| Conventional occupational therapyThey practised the same 10 tasks as in the SR-CIMT group described above. They received training for 2 weeks, 5 days a week (therapy days), the same as in the SR-CIMT and CIMT groups. | Other | Conventional occupational therapy |
Primary outcome
Change from baseline in Lawton Instrumental Activities of Daily Living Scale after the intervention
Time frame: Baseline and after the intervention (2 weeks)
Performance assessment on 8 daily tasks
Change from baseline in Lawton Instrumental Activities of Daily Living Scale at one month after the intervention completed
Time frame: Baseline and one month after the intervention completed (1 month and 2 weeks)
Performance assessment on 8 daily tasks
Change from baseline in Action Research Arm Test after the intervention
Time frame: Baseline and after the intervention (2 weeks)
Performance assessment on arm function
Change from baseline in Action Research Arm Test at one month after the intervention completed
Time frame: Baseline and one month after the intervention completed (1 month and 2 weeks)
Performance assessment on arm function
Change from baseline in Fugl Meyer Assessment, upper extremity motor subsection after the intervention
Time frame: Baseline and after the intervention (2 weeks)
Performance assessment on arm function
Change from baseline in Fugl Meyer Assessment, upper extremity motor subsection at one month after the intervention completed
Time frame: Baseline and one month after the intervention completed (1 month and 2 weeks)
Performance assessment on arm function
2 secondary outcomes
Change from baseline in Motor Activity Log-28 after the intervention
Time frame: Baseline and after the intervention (2 weeks)
Change from baseline in Motor Activity Log-28 at one month after the intervention completed
Time frame: Baseline and one month after the intervention completed (1 month and 2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
- BackgroundLam, K., Liu, K., Leung, T., Sum, C., Yue, A. & Mok, V. (2013, 24-26 July). The effectiveness of self-regulated constraint-induced movement therapy for functional regain for people with sub-acute stroke: A randomized controlled trial. Australian Occupational Therapy Journal, 110.
- BackgroundLeung, T., Liu, K.P.Y., Sum, C., Mok, V. & Lum, C. (2010). Self-regulation constraint-induced movement therapy programme for people with subacute stroke. Hong Kong Hospital Authority Rehabilitation Symposium.
- BackgroundLeung, T., Liu, K.P.Y., Sum, C., Mok, V. & Lum, C. (2010). Self-regulation constraint-induced movement therapy programme for people with subacute stroke. Hong Kong Journal of Occupational Therapy,19, A8.
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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.
Karen P.Y. Liu, PhD principal investigator
University of Western Sydney
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-regulated constraint-induced movement therapy, Constraint-induced movement therapy and Conventional occupational therapy in people with Stroke, run by University of Western Sydney at 2 sites in Hong Kong.
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 4 inclusion and 4 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 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from baseline in Lawton Instrumental Activities of Daily Living Scale after the intervention (time frame: Baseline and after the intervention (2 weeks)). The study lists 6 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 NCT02480140, which also lists 3 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 29 Jun 2015; AzTrials last refreshed its copy on 6 Nov 2026.