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Balance Training After Stroke With REWIRE (REWIRESI)

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ClinicalTrials.gov Identifier: NCT03282968
Recruitment Status : Completed
First Posted : September 14, 2017
Last Update Posted : April 10, 2018
Sponsor:
Collaborator:
Jozef Stefan Institute
Information provided by (Responsible Party):
University Rehabilitation Institute, Republic of Slovenia

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.

Condition or disease Intervention/treatment Phase
Stroke Device: REWIRE Other: Balance exercises Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Balance Training With the Rehabilitative Wayout In Responsive Home Environments (REWIRE) System in Patients After Stroke
Actual Study Start Date : January 3, 2017
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Experimental
Regular neurophysiotherapy plus REWIRE exercises
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.

Active Comparator: Control
Regular neurophysiotherapy plus standing balance exercises
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.




Primary Outcome Measures :
  1. Change in walking speed [ Time Frame: Assessment one day before and one day after the program ]
    Assessed using 10 Meter Walking Test

  2. Change in dynamic balance [ Time Frame: Assessment one day before and one day after the program ]
    Assessed using Four Step Square Test


Secondary Outcome Measures :
  1. Change in mobility [ Time Frame: Assessment one day before and one day after the program ]
    Assessed using Timed Up and Go test

  2. Change in static standing balance [ Time Frame: Assessment one day before and one day after the program ]
    Assessed using Romberg test



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282968


Locations
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Slovenia
University Rehabilitation Institute, Republic of Slovenia
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Rehabilitation Institute, Republic of Slovenia
Jozef Stefan Institute
Investigators
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Principal Investigator: Imre Cikajlo, PhD University Rehabilitation Institute, Rehabilitation of Slovenia

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Responsible Party: University Rehabilitation Institute, Republic of Slovenia
ClinicalTrials.gov Identifier: NCT03282968     History of Changes
Other Study ID Numbers: URIS201704
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Rehabilitation Institute, Republic of Slovenia:
exergaming
physiotherapy
balance
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases