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Completed

NCT Number: NCT02480140

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

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.

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Key information

Conditions

Stroke Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Self-Control Social Behavior Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shatin Hospital, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-regulated constraint-induced movement therapy

Other

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

Other

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

Other

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. Change from baseline in Motor Activity Log-28 after the intervention

    Time frame: Baseline and after the intervention (2 weeks)

    Self-reported assessment on daily function

  2. 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)

    Self-reported assessment on daily function

Sponsors and collaborators

Lead sponsor

University of Western Sydney

Other

Collaborators

  • The Hong Kong Polytechnic University

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 24, 2015
Registry last updated
Jun 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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