NCT00359255

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jul 2006

Typical duration for not_applicable stroke

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

2.4 years

First QC Date

July 28, 2006

Last Update Submit

May 8, 2017

Conditions

Stroke

Keywords

Exerciserehabilitationupper limbinpatientRCTactivities of daily living

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Study Arms (2)

1

ACTIVE COMPARATOR
Behavioral: Education manual

2

EXPERIMENTAL
Behavioral: An inpatient homework based exercise program for the upper limb post stroke

Interventions

Education manualBEHAVIORAL

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.

1
An inpatient homework based exercise program for the upper limb post strokeBEHAVIORAL

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.

2

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kelowna General Hospital

Kelowna, British Columbia, Canada

Location

GF Strong Rehab Center

Vancouver, British Columbia, Canada

Location

Holy Family Hospital

Vancouver, British Columbia, Canada

Location

Victoria General Hospital

Victoria, British Columbia, Canada

Location

Related 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: 10.1161/STROKEAHA.108.544585. Epub 2009 Apr 9.

    PMID: 19359633RESULT

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Janice Eng, Ph.D

    The University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 28, 2006

First Posted

August 1, 2006

Study Start

July 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

May 10, 2017

Record last verified: 2017-05

Locations

CA(4)