The Effect of Additional Arm Therapy on Arm Function After Stroke

May 8, 2017 updated by: Janice Eng, University of British Columbia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada
        • Kelowna General Hospital
      • Vancouver, British Columbia, Canada
        • GF Strong Rehab Center
      • Vancouver, British Columbia, Canada
        • Holy Family Hospital
      • Victoria, British Columbia, Canada
        • Victoria General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Heart and Stroke Foundation of Canada

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 28, 2006

First Submitted That Met QC Criteria

July 28, 2006

First Posted (Estimate)

August 1, 2006

Study Record Updates

Last Update Posted (Actual)

May 10, 2017

Last Update Submitted That Met QC Criteria

May 8, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C05-0680
  • VO6-0117

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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