NCT03282968

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

December 5, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

September 12, 2017

Last Update Submit

November 28, 2023

Conditions

Stroke

Keywords

exergamingphysiotherapybalance

Outcome Measures

Primary Outcomes (2)

  • Change in walking speed

    Assessed using 10 Meter Walking Test

    Assessment one day before and one day after the program

  • Change in dynamic balance

    Assessed using Four Step Square Test

    Assessment one day before and one day after the program

Secondary Outcomes (2)

  • 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

Study Arms (2)

Experimental

EXPERIMENTAL

Regular neurophysiotherapy plus REWIRE exercises

Device: REWIRE

Control

ACTIVE COMPARATOR

Regular neurophysiotherapy plus standing balance exercises

Other: Balance exercises

Interventions

REWIREDEVICE

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.

Experimental
Balance exercisesOTHER

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.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • first stroke
  • first admission to inpatient rehabilitation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

  • 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.

    PMID: 32300321DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Imre Cikajlo, PhD

    University Rehabilitation Institute, Rehabilitation of Slovenia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 14, 2017

Study Start

January 3, 2017

Primary Completion

July 1, 2017

Study Completion

March 31, 2018

Last Updated

December 5, 2023

Record last verified: 2023-11

Locations

SL(1)