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

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

Exercise Programs for Stroke: Effect of an Inpatient Supplementary Practice Program on Lower Extremity Function

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

142

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
      • Nanaimo, British Columbia, Canada
        • Nanaimo Regional General Hospital
      • Port Moody, British Columbia, Canada
        • Eagle Ridge 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:

  • 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

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: 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome is gait speed
Time Frame: 4 weeks post-intervention
4 weeks post-intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
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
4 weeks post-baseline, then 6 and 12 months post-stroke

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, 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

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

September 1, 2009

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

May 26, 2009

First Submitted That Met QC Criteria

May 26, 2009

First Posted (Estimate)

May 27, 2009

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

  • H09-00665

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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