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

Study Overview
=================
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.

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

Conditions
-----------------
Cerebrovascular Accident (Stroke)

Intervention / Treatment
-----------------
* Behavioral: Leg Exercise Program
* Behavioral: Leg Management group


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LE<br>Leg Exercise group | Behavioral: Leg Exercise Program<br>* 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.<br>* Other names: Inpatient supplementary practice program on lower extremity function;|
| Experimental: LM<br>Leg Management (Control group) | Behavioral: Leg Management group<br>* Therapist provides educational information about leg pain, recovery, bone density, and fall risk.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RCT, Exercise, Rehabilitation, leg function, in patient