The Effect of Additional Arm Therapy on Arm Function After Stroke

• ClinicalTrials.gov Identifier: NCT00359255
• Recruitment Status: Completed
• First Posted: August 1, 2006
• Last Update Posted: May 10, 2017
• Sponsor: University of British Columbia
• Collaborator: Heart and Stroke Foundation of Canada
• Information provided by (Responsible Party): Janice Eng, University of British Columbia

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stroke	Behavioral: Education manual; Behavioral: An inpatient homework based exercise program for the upper limb post stroke	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: The Effect of a Supplementary Exercise Program for Upper Extremity Function in Stroke Rehabilitation
• Study Start Date: July 2006
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: December 2008

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1	Behavioral: Education manual; The control arm was given education on stroke, the affected arm post strooke, bone health, and healthy living. This information was given in a booklet format and administered once weekly by the site coordinator.
Experimental: 2	Behavioral: An inpatient homework based exercise program for the upper limb post stroke; The experimental arm was given arm exercises graded based on motor impairment and administered by the site coordinator. The exercises were given in a booklet with written and photographic instructions. These exercises were monitored on a twice-weekly basis. The intervention was to be completed once daily for 45 minutes, 5 days per week, and supervised by the site coordinator. Exercises consisted of range of motion, strengthening, and use of the arm in daily activites such as buttoning, pouring and throwing.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Canada, British Columbia

Kelowna General Hospital

Kelowna, British Columbia, Canada

GF Strong Rehab Center

Vancouver, British Columbia, Canada

Holy Family Hospital

Vancouver, British Columbia, Canada

Victoria General Hospital

Victoria, British Columbia, Canada

Sponsors and Collaborators

University of British Columbia

Heart and Stroke Foundation of Canada

Investigators

• Principal Investigator: Janice Eng, Ph.D; The University of British Columbia

More Information

Publications of Results:

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.

• Responsible Party: Janice Eng, Principal Investigator, University of British Columbia
• ClinicalTrials.gov Identifier: NCT00359255
• Other Study ID Numbers: C05-0680; VO6-0117
• First Posted: August 1, 2006
• Last Update Posted: May 10, 2017
• Last Verified: May 2017

Keywords provided by Janice Eng, University of British Columbia:

Exercise; rehabilitation; upper limb; inpatient; RCT; activities of daily living

Additional relevant MeSH terms:

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