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Clinical Trials/NCT03282968
NCT03282968CompletedNot Applicable

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

University Rehabilitation Institute, Republic of Slovenia1 site in 1 country30 target enrollmentStarted: January 3, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Change in walking speed

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Device Feasibility
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Experimental

Experimental

Regular neurophysiotherapy plus REWIRE exercises

Intervention: REWIRE (Device)

Control

Active Comparator

Regular neurophysiotherapy plus standing balance exercises

Intervention: Balance exercises (Other)

Outcomes

Primary Outcomes

Change in walking speed

Time Frame: Assessment one day before and one day after the program

Assessed using 10 Meter Walking Test

Change in dynamic balance

Time Frame: Assessment one day before and one day after the program

Assessed using Four Step Square Test

Secondary Outcomes

  • Change in mobility(Assessment one day before and one day after the program)
  • Change in static standing balance(Assessment one day before and one day after the program)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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