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Completed

NCT Number: NCT01283620

Atlantic Canada Modified Constraint Induced Movement Therapy Trial

The purpose of this study is to examine the effectiveness and feasibility of a modified constraint induced movement therapy (mCIMT) intervention on upper limb function in two groups of patients acutely post-stroke; 1) an experimental group that will participate in a 10 week mCIMT intervention designed to improve upper limb function, in addition to usual care, and 2) a control group that will participate in a program of usual care consisting of a rehabilitation intervention for the affected upper limb that is dose-matched to the experimental group.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Capital Health

Halifax, Nova Scotia, B3H 3A7, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • first symptomatic stroke (either ischemic or hemorrhagic) resulting in upper limb hemiparesis
  • the ability to perform a two-step command
  • age ≥ 18 years
  • residence within a 75 km radius of the Queen Elizabeth II Health Sciences Centre
  • with regard to the affected upper limb, subjects will meet standard criteria for modified constraint induced movement therapy (mCIMT) including at least 10 degrees of active wrist extension, at least 10 degrees of thumb abduction/extension, and at least 10 degrees of extension in two additional digits, repeated three times in one minute

Exclusion criteria

  • have excessive pain in the affected upper limb (defined as > 4 on a 10 centimeter visual analog scale)
  • presence of dementia or aphasia as defined by a score of < 26 on the Montreal Cognitive Assessment
  • have a diagnosis of pre-stroke dementia
  • have a terminal illness, life-threatening co-morbidity or concomitant neurological or psychiatric illness
  • excessive tone in the upper limb (> 3 on the modified Ashworth Scale)
  • Motor Activity Log score > 2.5 (amount of use sub-scale)

Treatment and study plan

modified constraint induced movement therapy (mCIMT)

Behavioral

The intervention group will receive usual care plus mCIMT. mCIMT consists of two components delivered in parallel: three 30 min therapy sessions/week focusing on progressively more difficult tasks performed with the arm/hand, and five hours/weekday of restraint of the unaffected upper limb. Each 30 min therapy session consists of using the affected upper limb in practicing 4-5 functionally relevant tasks.

Usual and Customary Care

Other

Patients in this arm will receive usual care dose-matched to the experimental care group. Usual care will consist of occupational and physiotherapy intervention focused on affected upper limb range of motion (i.e., active range of motion incorporated into functional tasks such as reaching), strengthening (i.e., upper limb resisted exercise), manual dexterity exercises (i.e., grasp and release, stacking cones), and general aerobic conditioning (i.e., recumbent stepper, treadmill).

Primary outcomes

  1. Change in arm and hand function at 10 weeks, 6 and 12 months relative to baseline performance

    Time frame: At 0 weeks, 10 weeks, 6 months and 12 months

    Change in arm and hand function will be performed using the Action Research Arm Test, which measures function of the arm and hand using 19 tasks in four different categories (grip, grasp, pinch and gross motor). Performance on each task is scored from 0 (cannot perform any part of the test) to 3 (performs the test normally) for a possible score of 0-57. Improved arm and hand function will be determined by detecting a change in score by comparing performance at each of the post-treatment assessment points (10 weeks, 6 and 12 months) relative to baseline performance.

Secondary outcomes

  1. Change in the quality and amount of arm and hand use at 10 weeks, 6 and 12 months relative to baseline.

    Time frame: At 0 weeks, 10 weeks, 6 months and 12 months

    Improved arm and hand function based on the quality and amount of use will be determined by detecting a change in score by comparing performance at each post-treatment assessment point (10 weeks, 6 and 12 months) relative to baseline performance using the Motor Activity Log. The Motor Activity Log is a semi-structured interview which measures how much and how well a person is using the affected arm and hand compared to their pre-stroke condition.

  2. Greater satisfaction with treatment compared to the usual care group based on higher scores on the Satisfaction with Stroke Care Questionnaire (SASC-19) in the experimental treatment group

    Time frame: At 10 weeks

    Overall satisfaction with treatment will be measured in each group using the Satisfaction with Stroke Care Questionnaire (SASC-19), which includes 19 questions relating to a patients satisfaction with their care and treatment.

  3. Improved return to normal activities in the experimental treatment group as measured by higher scores on the Re-integration to Normal Living Index (RNLI) 6 months post-treatment

    Time frame: At 6 months

  4. Change in the amount of use of the arm and hand in everyday life at 10 weeks, 6 and 12 months relative to baseline as detected with accelerometers

    Time frame: At 0 weeks, 10 weeks, 6 months and 12 months

    Accelerometers will be worn on both wrists to quantitatively assess the amount of movement that occurs over a three day period at each of the time points. Improved use of the arm and hand will be determined based on a change in activity at each of the post-treatment assessment points (10 weeks, 6 and 12 months) relative to activity measured at baseline.

  5. Improved return to normal activities in the experimental treatment group as measured by higher scores on the Re-integration to Normal Living Index (RNLI) 12 months post-treatment

    Time frame: At 12 months

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Collaborators

  • Dalhousie University
  • Sunnybrook Research Institute

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 26, 2011
Registry last updated
May 7, 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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