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Self-regulated Constraint-induced Movement Therapy in Subacute Stroke Patients

Self-regulated Constraint-induced Movement Therapy in Subacute Stroke Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02480140
Enrollment
76
Registered
2015-06-24
Start date
2008-09-30
Completion date
2010-10-31
Last updated
2015-06-29

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

Conditions

Stroke

Keywords

Self-regulation, Constraint-induced movement therapy, Stroke, Functional recovery, Randomized controlled trial

Brief 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). 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.

Interventions

OTHERSelf-regulated constraint-induced movement therapy

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.

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.

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.

Sponsors

The Hong Kong Polytechnic University
CollaboratorOTHER
University of Western Sydney
Lead SponsorOTHER

Study design

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

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in Lawton Instrumental Activities of Daily Living Scale after the interventionBaseline 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 completedBaseline 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 interventionBaseline 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 completedBaseline 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 interventionBaseline 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 completedBaseline and one month after the intervention completed (1 month and 2 weeks)Performance assessment on arm function

Secondary

MeasureTime frameDescription
Change from baseline in Motor Activity Log-28 after the interventionBaseline and after the intervention (2 weeks)Self-reported assessment on daily function
Change from baseline in Motor Activity Log-28 at one month after the intervention completedBaseline and one month after the intervention completed (1 month and 2 weeks)Self-reported assessment on daily function

Countries

Hong Kong

Outcome results

None listed

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