Clinical trial NCT00359255: The Effect of Additional Arm Therapy on Arm Function After Stroke
Official title: The Effect of a Supplementary Exercise Program for Upper Extremity Function in Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Exercise
rehabilitation
upper limb
inpatient
RCT
activities of daily living
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
First posted: 2006-08-01
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study would focus on a new method of adding extra arm exercise to the usual therapy delivered in the hospital. We propose to design an exercise program for the affected arm and hand that would be given to the client as homework and done in the client's hospital room. The program would be designed and monitored by a therapist that works in the hospital.

We believe that this program will: 1) increase arm and hand recovery over usual care received in the hospital, 2) help people make the move from therapist run exercise to self management of exercise, and 3) promote family involvement in therapy.

Detailed description: In total 250 participants admitted for stroke rehabilitation at 4 BC sites will be randomly assigned to either the experimental or the control group. The extra arm and hand exercise program (experimental group) will receive usual therapy plus 60 minutes per day of additional arm exercises. This program will last for 4 weeks while the participant is in the hospital. The arm and hand program will include muscle strengthening and stretching, repetitive reaching, folding, stacking, pushing and pulling tasks, picking up objects, and activities that use speed and accuracy. The family will be encouraged to participate in the program with the participant. The control group will receive usual therapy only.

Eligibility criteria: Inclusion Criteria:

1. 19 years of age or older
2. arm recovery as a rehabilitation goal
3. have palpatable movement of wrist extension
4. able to follow 3 step verabal commands

Exclusion Criteria:

1. unstable cardiovascular status (congestive heart failure, uncontrolled hypertension, uncontrolled atrial fibrillation, or left ventricular failure),
2. significant musculo-skeletal problems (e.g., rheumatoid arthritis) or neurological conditions (e.g., Parkinson's disease) due to conditions other than stroke,
3. receptive aphasia

Primary outcomes:
measure: The primary outcome is the ability to use the paretic arm in activities of daily living. This outcome will be measured pre and post program.
Secondary outcomes:
measure: Secondary outcomes include amount of use and quality of movement of the paretic arm, motor recovery, strength, tone, and health related quality of life. Each of these measures will be evaluated pre and post program.
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: Kelowna General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: GF Strong Rehab Center
state: British Columbia
city: Vancouver
country: Canada
facility: Holy Family Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Victoria General Hospital
state: British Columbia
Study officials:
affiliation: The University of British Columbia
name: Janice Eng, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harris JE, Eng JJ, Miller WC, Dawson AS. A self-administered Graded Repetitive Arm Supplementary Program (GRASP) improves arm function during inpatient stroke rehabilitation: a multi-site randomized controlled trial. Stroke. 2009 Jun;40(6):2123-8. doi: 10.1161/STROKEAHA.108.544585. Epub 2009 Apr 9.