The Effect of an Inpatient Home-work Exercise Program on Leg Function After Stroke
Primary Purpose
Cerebrovascular Accident (Stroke)
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Leg Exercise Program
Leg Management group
Sponsored by

About this trial
This is an interventional other trial for Cerebrovascular Accident (Stroke) focused on measuring Exercise, Rehabilitation, leg function, in patient, RCT
Eligibility 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
Sites / Locations
- Nanaimo Regional General Hospital
- Eagle Ridge Hospital
- GF Strong Rehab Center
- Holy Family Hospital
- Victoria General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
LE
LM
Arm Description
Leg Exercise group
Leg Management (Control group)
Outcomes
Primary Outcome Measures
The primary outcome is gait speed
Secondary Outcome Measures
The secondary outcomes will assess the effect of the experimental intervention on balance and physical activity
Full Information
NCT ID
NCT00908479
First Posted
May 26, 2009
Last Updated
May 8, 2017
Sponsor
University of British Columbia
Collaborators
Heart and Stroke Foundation of Canada
1. Study Identification
Unique Protocol Identification Number
NCT00908479
Brief Title
The Effect of an Inpatient Home-work Exercise Program on Leg Function After Stroke
Official Title
Exercise Programs for Stroke: Effect of an Inpatient Supplementary Practice Program on Lower Extremity Function
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
April 2013 (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
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident (Stroke)
Keywords
Exercise, Rehabilitation, leg function, in patient, RCT
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LE
Arm Type
Experimental
Arm Description
Leg Exercise group
Arm Title
LM
Arm Type
Experimental
Arm Description
Leg Management (Control group)
Intervention Type
Behavioral
Intervention Name(s)
Leg Exercise Program
Other Intervention Name(s)
Inpatient supplementary practice program on lower extremity function
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Leg Management group
Intervention Description
Therapist provides educational information about leg pain, recovery, bone density, and fall risk.
Primary Outcome Measure Information:
Title
The primary outcome is gait speed
Time Frame
4 weeks post-intervention
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice Eng
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Miller
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Andrew Dawson
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Penny Brasher
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
Facility Information:
Facility Name
Nanaimo Regional General Hospital
City
Nanaimo
State/Province
British Columbia
Country
Canada
Facility Name
Eagle Ridge Hospital
City
Port Moody
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
Learn more about this trial
The Effect of an Inpatient Home-work Exercise Program on Leg Function After Stroke
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