The Effect of Additional Arm Therapy on Arm Function After Stroke

Stroke Clinical Trial

Official title:

The Effect of a Supplementary Exercise Program for Upper Extremity Function in Stroke Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00359255
• Other study ID #: C05-0680
• Secondary ID: VO6-0117
• Status: Completed
• Phase: N/A
• First received: July 28, 2006
• Last updated: May 8, 2017
• Start date: July 2006
• Est. completion date: December 2008

Study information

• Verified date: May 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	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

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Unspecified
Secondary	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.		Unspecified