Limitations of motor brain activity – use of virtual reality for simulation of therapeutic interventions

ISRCTN ISRCTN11757651
DOI https://doi.org/10.1186/ISRCTN11757651
Secondary identifying numbers 001-1
Submission date
29/07/2019
Registration date
01/08/2019
Last edited
15/09/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Persons with acquired brain injury (ABI) and traumatic brain injury (TBI) are in need of neuro-rehabilitation/repair. Virtual anatomical interactivity (VAI) can take a digital game-like form, where the survivors can perform exercises and tasks in virtual world. The aims of the study were to determine for stroke and traumatic brain injury survivors:
1) the effects, if any, of virtual limb control on improving movements of impaired limbs; and
2) brain changes, if any, related to motor improvements.

Who can participate?
Stroke and traumatic brain injury survivors aged over 21 years, who are actively engaged in physical and occupational therapy

What does the study involve?
Traditional stroke therapy (hands-on by therapists, with or without assistive devices) was tested independently of any other therapy, secondly by adding virtual limb control to traditional therapy and, thirdly by survivors using only a standard computer mouse to point a cursor to all or any part of an anatomically realistic virtual limb with true range of motion. Survivors controlled virtual limbs to simulate a desired unimpaired physical movement. Three therapeutic modalities illustrated the difference between traditional therapy, a physical solution to a neurological problem (brain neural insult) and virtual limb control therapy, a neurological solution to a neurological problem.

What are the possible benefits and risks of participating?
The benefits are supplementary, non-invasive, self-administered rehabilitation exercises in an entertaining video game-like format which encourages repetition. Feedback, while virtual visuo-motor is adopted as real by survivor-participants as next best to real feedback and since survivors were hemiparetic, next best to assisted limb movement therapy. The risks were non-existent. PAGEs are presented in a slow video game format.

Where is the study run from?
Kladruby Rehabilitation Facility, Czechia

When is the study starting and how long is it expected to run for?
January to April 2015

Who is funding the study?
3DPreMotorSkills, LLC, USA

Who is the main contact?
Vincent Macri,
vjm@vincemacri.us

Study website

Contact information

Mr Vincent Macri
Public

434 Lacy Woods Court
Tallahassee
32312
United States of America

Phone 603-502-6068
Email vjm@vincemacri.us

Study information

Study designInterventional randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titlePre-Action Games and Exercises: Utility of virtual reality as supplemental stroke survivor rehabilitation in stroke and/or traumatic brain injury survivors to examine change in functional motor performance and volumetric cortical grey matter
Study acronymPAGEs
Study objectivesStroke survivors controlling virtual limbs will improve functional use of impaired limbs and experience cortical grey matter change
Ethics approval(s)Approved 03/02/2015, Ethics Board of Rehabilitation Centre Kladruby (Rehabilitační ústav Kladruby
Kladruby 30, 257 62 Kladruby u Vlašimi; (+420) 317 881 219 ;kristyna.hoidekrova@rehabilitace.cz), ref: No reference number.
Health condition(s) or problem(s) studiedIschemic stroke and traumatic brain injury
InterventionThe intervention included traditional physical and occupational therapy and controlling virtual limbs to simulate unimpaired physical movement.

The subjects were divided into three groups:
- Group A received traditional stroke rehabilitation (VAI) therapy only
- Group B received VAI and physical/occupational therapy (P/OT)
- Group C received P/OT only.
(Group A participants were out-patients, groups B and C included in-patients)

Motor skills were evaluated by muscle strength (hand key pinch strength, grasp and three-jaw pinch) and active range of motion (AROM) of shoulder, elbow, and wrist. Their changes were analysed by ANOVA, ANCOVA and one-tailed Pearson correlation analysis. MRI data for brain changes were analysed using voxel-based morphometry and correlated with quantified motor skills.

The total duration of treatment was 10 weeks 3 sessions per week approximately 30 minutes per session. Funding limitations precluded follow-up. Randomisation was based on 100% volunteer sign-ups for the study.
Intervention typeOther
Primary outcome measureMeasured at baseline (1-3 days before intervention) and post-intervention (10-weeks).
1. Changes in cortical grey matter volume measured using MRI data analyzed using voxel-based morphometry and correlated with quantified motor skills
2. Motor skills evaluated by muscle strength (hand key pinch strength, grasp and three-jaw pinch) and active range of motion (AROM) of shoulder, elbow, and wrist
Secondary outcome measuresNone
Overall study start date10/12/2014
Completion date30/04/2015

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants35
Total final enrolment35
Key inclusion criteria1. Stroke survivors
2. Traumatic brain injury survivors
3. Actively engaged in physical and occupational therapy
4. Age range: 21 years and older
5. Gender: male or female
Key exclusion criteria1. Patients unable to comprehend use of standard computer mouse to point to and control virtual limbs
Date of first enrolment10/01/2015
Date of final enrolment31/01/2015

Locations

Countries of recruitment

  • Czech Republic

Study participating centre

Kladruby Rehabilitation Facility
Kladruby
349 61
Czech Republic

Sponsor information

3DPreMotorSkills, LLC
Research organisation

434 Lacy Woods Court
Tallahassee
32312
United States of America

Phone 603-502-6068
Email vjm@vincemacri.us
Website http://www.neurojungle.com

Funders

Funder type

Industry

3DPreMotorSkills, LLC

No information available

Results and Publications

Intention to publish date01/09/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planIt is currently under peer review with a first set of reviewers comments by the Journal of NeuroEngineering and Rehabilitation
IPD sharing planAll data generated or analysed during this study will be included in the subsequent results publication

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 12/09/2020 15/09/2020 Yes No

Editorial Notes

15/09/2020: Publication reference and total final enrolment number added.
27/08/2019: Internal review.
01/08/2019: Trial’s existence confirmed by Ethics Board of Rehabilitation Centre Kladruby. The ethics approval was added.