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The Effect of an Inpatient Home-work Exercise Program on Leg Function After Stroke

This study is currently recruiting participants.
Verified November 2011 by University of British Columbia
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00908479
First received: May 26, 2009
Last updated: November 21, 2011
Last verified: November 2011
History of Changes
  Purpose

This study would focus on a new method of adding extra leg homework exercises to the usual therapy delivered in the hospital. We propose to design an exercise program for the affected leg that would be given to the client as homework and done in the client's hospital room or ward. The program would be designed and monitored by a therapist that works in the hospital.


Condition Intervention
Cerebrovascular Accident (Stroke)
 Behavioral: Leg Exercise Program
Behavioral: Leg Management group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Exercise Programs for Stroke: Effect of an Inpatient Supplementary Practice Program on Lower Extremity Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • The primary outcome is gait speed [ Time Frame: 4 weeks post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcomes will assess the effect of the experimental intervention on balance and physical activity [ Time Frame: 4 weeks post-baseline, then 6 and 12 months post-stroke ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LE
Leg Exercise group
 Behavioral: Leg Exercise Program
Participants will engage in an extra 45-60 minutes per day of self-managed lower extremity homework exercises focused on improving strength, balance and walking ability.
Other Name: Inpatient supplementary practice program on lower extremity function
Experimental: LM
Leg Management (Control group)
 Behavioral: Leg Management group
Therapist provides educational information about leg pain, recovery, bone density, and fall risk.

Detailed Description:

In total 120 participants admitted for stroke rehabilitation in the province British Columbia, Canada will be randomly assigned to either the Leg Exercise group or Leg Management group. The extra leg exercise group (experimental group) will receive usual therapy plus 60 minutes per day of self-directed leg exercises. This program will last for 4 weeks while the participant is in the hospital. The Leg Exercise program will include exercises of range of motion, leg strengthening, weight-bearing, and walking. The family will be encouraged to participate in the program with the participant. The control group (Leg Management group) will receive usual therapy and stroke education.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have been admitted to a hospital unit for stroke treatment
  • 19 years or older
  • Are experiencing difficulty using legs
  • Able to understand and follow instructions

Exclusion Criteria:

  • Have uncontrolled hypertension or unstable cardio-vascular condition
  • Injuries to muscles, bones, or joints of the leg
  • Unable to verbally speak or understand the investigators when asked questions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908479

Contacts
Contact: Chihya Hung 604-714-4108 Chihya.Hung@vch.ca

Locations
Canada, British Columbia
Nanaimo Regional General Hospital Recruiting
Nanaimo, British Columbia, Canada
Eagle Ridge Hospital Recruiting
Port Moody, British Columbia, Canada
GF Strong Rehab Center Recruiting
Vancouver, British Columbia, Canada
Holy Family Hospital Recruiting
Vancouver, British Columbia, Canada
Victoria General Hospital Recruiting
Victoria, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Heart and Stroke Foundation of Canada
Investigators
Principal Investigator: Janice Eng University of British Columbia
Study Director: William Miller University of British Columbia
Study Director: Andrew Dawson University of British Columbia
Study Director: Penny Brasher University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00908479     History of Changes
Other Study ID Numbers: H09-00665
Study First Received: May 26, 2009
Last Updated: November 21, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Exercise
Rehabilitation
leg function
in patient
RCT

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

ClinicalTrials.gov processed this record on May 23, 2013