The Effect of Additional Arm Therapy on Arm Function After Stroke

Sponsor

University of British Columbia (Other)

Overall Status

Completed

CT.gov ID

NCT00359255

Collaborator

Heart and Stroke Foundation of Canada (Other)

120

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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	N/A

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

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 :

Jul 1, 2006

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 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.

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

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

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

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Kelowna General Hospital	Kelowna	British Columbia	Canada
2	GF Strong Rehab Center	Vancouver	British Columbia	Canada
3	Holy Family Hospital	Vancouver	British Columbia	Canada
4	Victoria General Hospital	Victoria	British Columbia	Canada