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Atlantic Canada Modified Constraint Induced Movement Therapy Trial

N

Nova Scotia Health Authority (NSHA)

Status

Completed

Conditions

Stroke

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01283620
CDHA-RS/2011-277

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

14 participants in 2 patient groups

Usual Care
Other group
Treatment:
Other: Usual and Customary Care
modified CIMT (mCIMT)
Experimental group
Treatment:
Behavioral: modified constraint induced movement therapy (mCIMT)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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