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Atlantic Canada Modified Constraint Induced Movement Therapy Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Capital District Health Authority, Canada
Sponsor:
Collaborators:
Dalhousie University
Sunnybrook Research Institute
Information provided by (Responsible Party):
Shaun Boe, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01283620
First received: January 21, 2011
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Stroke
Behavioral: modified constraint induced movement therapy (mCIMT)
Other: Usual and Customary Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Atlantic Canada Modified Constraint Induced Movement Therapy Trial

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Usual Care Other: Usual and Customary Care
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).
Experimental: modified CIMT (mCIMT) Behavioral: modified constraint induced movement therapy (mCIMT)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. first symptomatic stroke (either ischemic or hemorrhagic) resulting in upper limb hemiparesis
  2. the ability to perform a two-step command
  3. age ≥ 18 years
  4. residence within a 75 km radius of the Queen Elizabeth II Health Sciences Centre
  5. 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:

  1. have excessive pain in the affected upper limb (defined as > 4 on a 10 centimeter visual analog scale)
  2. presence of dementia or aphasia as defined by a score of < 26 on the Montreal Cognitive Assessment
  3. have a diagnosis of pre-stroke dementia
  4. have a terminal illness, life-threatening co-morbidity or concomitant neurological or psychiatric illness
  5. excessive tone in the upper limb (> 3 on the modified Ashworth Scale)
  6. Motor Activity Log score > 2.5 (amount of use sub-scale)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283620

Contacts
Contact: Shaun G Boe, MPT, PhD 902-494-6360 s.boe@dal.ca

Locations
Canada, Nova Scotia
Capital Health Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Principal Investigator: Shaun G Boe, MPT, PhD         
Sponsors and Collaborators
Capital District Health Authority, Canada
Dalhousie University
Sunnybrook Research Institute
Investigators
Principal Investigator: Shaun G Boe, MPT, PhD Dalhousie University/Capital Health
  More Information

No publications provided

Responsible Party: Shaun Boe, Affiliate Scientist, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01283620     History of Changes
Other Study ID Numbers: CDHA-RS/2011-277
Study First Received: January 21, 2011
Last Updated: March 6, 2014
Health Authority: Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
stroke
extremity, upper

ClinicalTrials.gov processed this record on November 20, 2014