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Trial registered on ANZCTR


Registration number
ACTRN12615000604505
Ethics application status
Approved
Date submitted
25/05/2015
Date registered
9/06/2015
Date last updated
9/06/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomized Controlled Trial of Self-regulated Constraint-induced Movement Therapy to promote functional regain in Subacute Stroke Patients
Scientific title
A Randomized Controlled Trial of Self-regulated Constraint-induced Movement Therapy as compared with conventional occupational therapy to promote functional regain in Subacute Stroke Patients
Secondary ID [1] 286798 0
Nil
Universal Trial Number (UTN)
U1111-1166-8303
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subacute stroke 295175 0
Condition category
Condition code
Stroke 295419 295419 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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. 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.
Intervention code [1] 291956 0
Rehabilitation
Comparator / control treatment
1. Control intervention - conventional occupational therapy involving therapist to demonstrate the adapted task performance followed by patient’s practice under supervision. 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.

2. Constraint-induced movement therapy (CIMT) - 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. 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.
Control group
Active

Outcomes
Primary outcome [1] 295154 0
Lawton Instrumental Activities of Daily Living Scale (Lawton IADL)
Timepoint [1] 295154 0
Baseline, after the intervention and at one month after intervention completed
Primary outcome [2] 295155 0
Action Research Arm Test (ARAT)
Timepoint [2] 295155 0
Baseline, after the intervention and at one month after intervention completed
Primary outcome [3] 295156 0
Fugl Meyer Assessment (FMA), upper extremity motor subsection
Timepoint [3] 295156 0
Baseline, after the intervention and at one month after intervention completed
Secondary outcome [1] 314887 0
Motor Activity Log - 28 (MAL)
Timepoint [1] 314887 0
Baseline, after the intervention and at one month after intervention completed

Eligibility
Key inclusion criteria
Patients receiving in-patient rehabilitation post-stroke were recruited from a rehabilitation hospital.

Patients were eligible if they:
(1) had sustained an ischemic type stroke with lesion in the primary or motor cortical areas resulting in hemiplegia,
(2) had stroke onset of less than 3 months,
(3) were aged above 60,
(4) had 10 degree active extension in metacarpophalangeal joint and interphalangeal joint, 20 degree active extension of wrist joint.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) had excessive spasticity in the affected limb, as defined by a score of 2 or more on the Modified Ashworth Scale,
(2) had excessive pain in the affected limb, as defined by a score 4 or more using a Visual Analog Scale,
(3) had a score below 19 on the Mini-Mental Status Examination (MMSE), and
(4) had diagnosed of depression according to DSM-IV criteria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible patients were randomized by drawing lots using three sealed opaque envelopes (for the three intervention groups). The randomization was conducted by a blinded researcher who was not involved in delivering the interventions or study measures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by drawing lots using three sealed opaque envelopes (for the three intervention groups)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using PASS 13 software, based on the parameters used for ANOVA tests, and with reference to the results obtained from the previous CIMT study, the total sample size of 20 in each group would give a power of 80%, an alpha value of 0.05 and effect size of 0.50.

Differences among the three groups in demographic variables were assessed using analysis of variance (ANOVA) and chi square test; and in study measures at baseline were assessed using the Kruskal-Wallis test. For changes in the study measures among baseline, after intervention and one month after the intervention completed in each group, Friedman test was used. Differences in the gains across the study measures, before and after intervention, among the three groups were measured using the Kruskai-Wallis test. Mann-Whitney U test was used to further test the differences, if any, between any of the two groups. Significance level was set at a 2-tailed P<0.050 for all comparisons.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/09/2008
Date of last participant enrolment
Anticipated
Actual
12/10/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
81
Accrual to date
Final
Recruitment outside Australia
Country [1] 6903 0
Hong Kong
State/province [1] 6903 0
Hong Kong

Funding & Sponsors
Funding source category [1] 291340 0
University
Name [1] 291340 0
The Hong Kong Polytechnic University
Country [1] 291340 0
Hong Kong
Funding source category [2] 291341 0
University
Name [2] 291341 0
University of Western Sydney
Country [2] 291341 0
Australia
Primary sponsor type
University
Name
The Hong Kong Polytechnic University
Address
The Hong Kong Polytechnic University
11 Yuk Choi Rd
Hung Hom
Kowloon
Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 290020 0
University
Name [1] 290020 0
University of Western Sydney
Address [1] 290020 0
University of Western Sydney
Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751
Australia
Country [1] 290020 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292902 0
The Hong Kong Polytechnic University
Ethics committee address [1] 292902 0
Ethics committee country [1] 292902 0
Hong Kong
Date submitted for ethics approval [1] 292902 0
Approval date [1] 292902 0
02/11/2009
Ethics approval number [1] 292902 0
NA
Ethics committee name [2] 292903 0
Joint the Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee
Ethics committee address [2] 292903 0
Ethics committee country [2] 292903 0
Hong Kong
Date submitted for ethics approval [2] 292903 0
Approval date [2] 292903 0
06/05/2008
Ethics approval number [2] 292903 0
CRE-2008.192-T
Ethics committee name [3] 292904 0
New Territories West Cluster Clinical and Research Ethics Committee
Ethics committee address [3] 292904 0
Ethics committee country [3] 292904 0
Hong Kong
Date submitted for ethics approval [3] 292904 0
Approval date [3] 292904 0
11/08/2009
Ethics approval number [3] 292904 0
NA

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 462 462 0 0
/AnzctrAttachments/368627-PolyU ethicsapprovalletter_extend to 31Dec2010.pdf
Attachments [2] 463 463 0 0
/AnzctrAttachments/368627-Ethics approval.pdf
Attachments [3] 464 464 0 0
/AnzctrAttachments/368627-TMH cluster ethics approval.pdf

Contacts
Principal investigator
Name 57566 0
A/Prof Karen Liu
Address 57566 0
University of Western Sydney
Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751
Country 57566 0
Australia
Phone 57566 0
+61 2 46203432
Fax 57566 0
Email 57566 0
karen.liu@uws.edu.au
Contact person for public queries
Name 57567 0
Karen Liu
Address 57567 0
University of Western Sydney
Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751
Country 57567 0
Australia
Phone 57567 0
+61 2 46203432
Fax 57567 0
Email 57567 0
karen.liu@uws.edu.au
Contact person for scientific queries
Name 57568 0
Karen Liu
Address 57568 0
University of Western Sydney
Campbelltown Campus
Locked Bag 1797
Penrith NSW 2751
Country 57568 0
Australia
Phone 57568 0
+61 2 46203432
Fax 57568 0
Email 57568 0
karen.liu@uws.edu.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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