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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02480140
• Other study ID #: SR-CIMT
• Status: Completed
• Phase: N/A
• First received: June 18, 2015
• Last updated: June 26, 2015
• Start date: September 2008
• Est. completion date: October 2010

Study information

• Verified date: June 2015
• Source: University of Western Sydney
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: University of Western Sydney
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Self-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.
• Constraint-induced movement therapy
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 therapy
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.

Locations

Country	Name	City	State
Hong Kong	Shatin Hospital	Hong Kong
Hong Kong	Pok Oi Hospital	Yuen Long

Sponsors (2)

Lead Sponsor	Collaborator
University of Western Sydney	The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

References & Publications (3)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Lawton Instrumental Activities of Daily Living Scale after the intervention	Performance assessment on 8 daily tasks	Baseline and after the intervention (2 weeks)	No
Primary	Change from baseline in Lawton Instrumental Activities of Daily Living Scale at one month after the intervention completed	Performance assessment on 8 daily tasks	Baseline and one month after the intervention completed (1 month and 2 weeks)	No
Primary	Change from baseline in Action Research Arm Test after the intervention	Performance assessment on arm function	Baseline and after the intervention (2 weeks)	No
Primary	Change from baseline in Action Research Arm Test at one month after the intervention completed	Performance assessment on arm function	Baseline and one month after the intervention completed (1 month and 2 weeks)	No
Primary	Change from baseline in Fugl Meyer Assessment, upper extremity motor subsection after the intervention	Performance assessment on arm function	Baseline and after the intervention (2 weeks)	No
Primary	Change from baseline in Fugl Meyer Assessment, upper extremity motor subsection at one month after the intervention completed	Performance assessment on arm function	Baseline and one month after the intervention completed (1 month and 2 weeks)	No
Secondary	Change from baseline in Motor Activity Log-28 after the intervention	Self-reported assessment on daily function	Baseline and after the intervention (2 weeks)	No
Secondary	Change from baseline in Motor Activity Log-28 at one month after the intervention completed	Self-reported assessment on daily function	Baseline and one month after the intervention completed (1 month and 2 weeks)	No