The Effect of Additional Arm Therapy on Arm Function After Stroke

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00359255
First received: July 28, 2006
Last updated: July 8, 2009
Last verified: July 2009
  Purpose

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 Intervention
Stroke
Behavioral: Education manual
Behavioral: An inpatient homework based exercise program for the upper limb post stroke

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: The Effect of a Supplementary Exercise Program for Upper Extremity Function in Stroke Rehabilitation

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

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. [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

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. [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: July 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359255

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 Ontario
Investigators
Principal Investigator: Janice Eng, Ph.D The University of British Columbia
  More Information

Publications:
Responsible Party: Dr. Janice Eng, University of British Columbia
ClinicalTrials.gov Identifier: NCT00359255     History of Changes
Other Study ID Numbers: C05-0680, VO6-0117
Study First Received: July 28, 2006
Last Updated: July 8, 2009
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Exercise
rehabilitation
upper limb
inpatient
RCT
activities of daily living

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 20, 2014