Atlantic Canada Modified Constraint Induced Movement Therapy Trial

NCT01283620 | Completed

• 1 other identifier: CDHA-RS/2011-277
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

stroke; extremity, upper

Outcome Measures

Primary Outcomes (1)

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

  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.

  At 0 weeks, 10 weeks, 6 months and 12 months

Secondary Outcomes (5)

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

  At 0 weeks, 10 weeks, 6 months and 12 months

• 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

  At 10 weeks

• 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

  At 6 months

• 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

  At 0 weeks, 10 weeks, 6 months and 12 months

• 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

  At 12 months

Study Arms (2)

Usual Care

OTHER

Other: Usual and Customary Care

modified CIMT (mCIMT)

EXPERIMENTAL

Behavioral: modified constraint induced movement therapy (mCIMT)

Interventions

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.

modified CIMT (mCIMT)

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).

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Dalhousie University: collaborator
• Sunnybrook Research Institute: collaborator

Study Sites (1)

Capital Health

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Shaun G Boe, MPT, PhD

  Dalhousie University/Capital Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affiliate Scientist

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: January 26, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 7, 2015

Record last verified: 2015-05

Locations

CA (1)