Balance Training After Stroke With REWIRE (REWIRESI)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
REWIRE
Balance exercises
Sponsored by

About this trial
This is an interventional device feasibility trial for Stroke focused on measuring exergaming, physiotherapy, balance
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
Sites / Locations
- University Rehabilitation Institute, Republic of Slovenia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Control
Arm Description
Regular neurophysiotherapy plus REWIRE exercises
Regular neurophysiotherapy plus standing balance exercises
Outcomes
Primary Outcome Measures
Change in walking speed
Assessed using 10 Meter Walking Test
Change in dynamic balance
Assessed using Four Step Square Test
Secondary Outcome Measures
Change in mobility
Assessed using Timed Up and Go test
Change in static standing balance
Assessed using Romberg test
Full Information
NCT ID
NCT03282968
First Posted
September 12, 2017
Last Updated
April 9, 2018
Sponsor
University Rehabilitation Institute, Republic of Slovenia
Collaborators
Jozef Stefan Institute
1. Study Identification
Unique Protocol Identification Number
NCT03282968
Brief Title
Balance Training After Stroke With REWIRE
Acronym
REWIRESI
Official Title
Balance Training With the Rehabilitative Wayout In Responsive Home Environments (REWIRE) System in Patients After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 3, 2017 (Actual)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
March 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Rehabilitation Institute, Republic of Slovenia
Collaborators
Jozef Stefan Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will include 20 patients after troke, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
exergaming, physiotherapy, balance
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Regular neurophysiotherapy plus REWIRE exercises
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Regular neurophysiotherapy plus standing balance exercises
Intervention Type
Device
Intervention Name(s)
REWIRE
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Balance exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in walking speed
Description
Assessed using 10 Meter Walking Test
Time Frame
Assessment one day before and one day after the program
Title
Change in dynamic balance
Description
Assessed using Four Step Square Test
Time Frame
Assessment one day before and one day after the program
Secondary Outcome Measure Information:
Title
Change in mobility
Description
Assessed using Timed Up and Go test
Time Frame
Assessment one day before and one day after the program
Title
Change in static standing balance
Description
Assessed using Romberg test
Time Frame
Assessment one day before and one day after the program
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imre Cikajlo, PhD
Organizational Affiliation
University Rehabilitation Institute, Rehabilitation of Slovenia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Rehabilitation Institute, Republic of Slovenia
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32300321
Citation
Cikajlo I, Rudolf M, Mainetti R, Borghese NA. Multi-Exergames to Set Targets and Supplement the Intensified Conventional Balance Training in Patients With Stroke: A Randomized Pilot Trial. Front Psychol. 2020 Apr 2;11:572. doi: 10.3389/fpsyg.2020.00572. eCollection 2020.
Results Reference
derived
Learn more about this trial
Balance Training After Stroke With REWIRE
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