Balance Training After Stroke With REWIRE

Study Overview
=================
Brief Summary
-----------------
The study will include 20 patients after stroke, randomly assigned to the experimental and control group (10 each). In both groups, the program with last for five days; walking and balance will be assessed before and after the program. Both groups will receive regular neurophysiotherapy; in addition, the experimental group will exercise each day by playing REWIRE games, while the control group will perform standing balance exercises.

Detailed Description
-----------------
Detailed inclusion and exclusion criteria are specified in the appropriate section. Both groups will perform the additional exercises for 15 minutes daily. In addition to the outcome measurement, informal feedback will be obtained from the patients and the therapists on the feasibility of the REWIRE system.

Official Title
-----------------
Balance Training With the Rehabilitative Wayout In Responsive Home Environments (REWIRE) System in Patients After Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: REWIRE
* Other: Balance exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first stroke first admission to inpatient rehabilitation Exclusion Criteria: less than 25 points scored on the Mini-Mental State Examination inability to walk independently

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Regular neurophysiotherapy plus REWIRE exercises | Device: REWIRE<br>* First, the patient will play the Fruit Catcher (weight transfer) game on the 3rd level for 3 minutes, followed by 3 minutes of rest. Next, the patient will play the Horse Runner (squats) on the 3rd level for 3 minutes, followed by 3 minutes of rest. In the end, the patient will play the Animal Hurdler (standing on one leg) on the 3rd level for 3 minutes. During the games, the patient will be standing on the Wii Balance Board, holding to a firm support if necessary. During the rest periods, the patients will be sitting. A physiotherapist will be present throughout the exercise for safety and help if requested.<br>|
| Active Comparator: Control<br>Regular neurophysiotherapy plus standing balance exercises | Other: Balance exercises<br>* The patient will first practice balance transfer for 3 minutes (standing by a ladder, holding position on each leg for 3 seconds), followed by 3 minutes of rest. Next, the patient will be performing squats for 3 minutes, followed by 3 minutes of rest. In the end, the patient will practice alternatively lifting lower limbs (like stepping on a footstool) for 3 minutes. During the rest periods, the patients will be sitting. A physiotherapist will be present throughout the exercise for safety and help if requested.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in walking speed | Assessed using 10 Meter Walking Test | Assessment one day before and one day after the program | 
| Change in dynamic balance | Assessed using Four Step Square Test | Assessment one day before and one day after the program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mobility | Assessed using Timed Up and Go test | Assessment one day before and one day after the program | 
| Change in static standing balance | Assessed using Romberg test | Assessment one day before and one day after the program | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exergaming, physiotherapy, balance