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CompletedNCT03282968REWIRESIUpdated Dec 5, 2023

Balance Training After Stroke With REWIRE

An interventional study of REWIRE and Balance exercises in Stroke, sponsored by University Rehabilitation Institute, Republic of Slovenia. Completed at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-05.

Sponsored by University Rehabilitation Institute, Republic of Slovenia · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stroke

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Keywords

  • exergaming
  • physiotherapy
  • balance
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • first stroke
  • first admission to inpatient rehabilitation

Exclusion criteria

Exclusion Criteria:

  • less than 25 points scored on the Mini-Mental State Examination
  • inability to walk independently
04

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Experimental

    Regular neurophysiotherapy plus REWIRE exercises

    Device: REWIRE

  • Active comparator
    Control

    Regular neurophysiotherapy plus standing balance exercises

    Other: Balance exercises

Interventions

  • DeviceREWIRE

    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.

  • OtherBalance 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.

05

What researchers measure

Primary outcomes

  1. Change in walking speed

    Assessed using 10 Meter Walking Test

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

  2. Change in dynamic balance

    Assessed using Four Step Square Test

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

Secondary outcomes

  1. Change in mobility

    Assessed using Timed Up and Go test

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

  2. Change in static standing balance

    Assessed using Romberg test

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

06

Study locations

1 site
  • University Rehabilitation Institute, Republic of Slovenia
    Ljubljana, 1000, Slovenia
07

References and documents

Publications

  • 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. PubMed 32300321 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03282968
Lead sponsor
University Rehabilitation Institute, Republic of Slovenia
Collaborators
Jozef Stefan Institute
Responsible party
Sponsor
First posted
Sep 14, 2017
Start date
Jan 3, 2017
Primary completion
Jul 1, 2017
Completion
Mar 31, 2018
Last update
Dec 5, 2023

Study contacts

Imre Cikajlo, PhD
principal investigator · University Rehabilitation Institute, Rehabilitation of Slovenia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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