Balance Training After Stroke With REWIRE

Stroke Clinical Trial

— REWIRESI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03282968
• Other study ID #: URIS201704
• Status: Completed
• Phase: N/A
• Start date: January 3, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: November 2023
• Source: University Rehabilitation Institute, Republic of Slovenia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 31, 2018
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• REWIRE
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.

Other:
• Balance exercises
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.

Locations

Country	Name	City	State
Slovenia	University Rehabilitation Institute, Republic of Slovenia	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University Rehabilitation Institute, Republic of Slovenia	Jozef Stefan Institute

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in walking speed	Assessed using 10 Meter Walking Test	Assessment one day before and one day after the program
Primary	Change in dynamic balance	Assessed using Four Step Square Test	Assessment one day before and one day after the program
Secondary	Change in mobility	Assessed using Timed Up and Go test	Assessment one day before and one day after the program
Secondary	Change in static standing balance	Assessed using Romberg test	Assessment one day before and one day after the program