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

Cerebrovascular Accident (Stroke) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00908479
• Other study ID #: H09-00665
• Status: Completed
• Phase: N/A
• First received: May 26, 2009
• Last updated: May 8, 2017
• Start date: September 2009
• Est. completion date: April 2013

Study information

• Verified date: May 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: April 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Accident (Stroke)
• Stroke

Intervention

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.
• Leg Management group
Therapist provides educational information about leg pain, recovery, bone density, and fall risk.

Locations

Country	Name	City	State
Canada	Nanaimo Regional General Hospital	Nanaimo	British Columbia
Canada	Eagle Ridge Hospital	Port Moody	British Columbia
Canada	GF Strong Rehab Center	Vancouver	British Columbia
Canada	Holy Family Hospital	Vancouver	British Columbia
Canada	Victoria General Hospital	Victoria	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome is gait speed		4 weeks post-intervention
Secondary	The secondary outcomes will assess the effect of the experimental intervention on balance and physical activity		4 weeks post-baseline, then 6 and 12 months post-stroke