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The Effect of Additional Arm Therapy on Arm Function After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Education manual
An inpatient homework based exercise program for the upper limb post stroke
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring Exercise, rehabilitation, upper limb, inpatient, RCT, activities of daily living

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kelowna General Hospital
  • GF Strong Rehab Center
  • Holy Family Hospital
  • Victoria General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Outcomes

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.

Full Information

First Posted
July 28, 2006
Last Updated
May 8, 2017
Sponsor
University of British Columbia
Collaborators
Heart and Stroke Foundation of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT00359255
Brief Title
The Effect of Additional Arm Therapy on Arm Function After Stroke
Official Title
The Effect of a Supplementary Exercise Program for Upper Extremity Function in Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Heart and Stroke Foundation of Canada

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Exercise, rehabilitation, upper limb, inpatient, RCT, activities of daily living

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Education manual
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
An inpatient homework based exercise program for the upper limb post stroke
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice Eng, Ph.D
Organizational Affiliation
The University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kelowna General Hospital
City
Kelowna
State/Province
British Columbia
Country
Canada
Facility Name
GF Strong Rehab Center
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Holy Family Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Victoria General Hospital
City
Victoria
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19359633
Citation
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.
Results Reference
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The Effect of Additional Arm Therapy on Arm Function After Stroke

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