Plain English Summary
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?
Mr Vincent Macri
434 Lacy Woods Court
United States of America
Pre-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
Stroke survivors controlling virtual limbs will improve functional use of impaired limbs and experience cortical grey matter change
Approved 03/02/2015, Ethics Board of Rehabilitation Centre Kladruby (Rehabilitační ústav Kladruby
Kladruby 30, 257 62 Kladruby u Vlašimi; (+420) 317 881 219 ;firstname.lastname@example.org), ref: No reference number.
Interventional randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Ischemic stroke and traumatic brain injury
The 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.
Primary outcome measure
Measured 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 measures
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. 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
Target number of participants
Participant exclusion criteria
1. Patients unable to comprehend use of standard computer mouse to point to and control virtual limbs
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Kladruby Rehabilitation Facility
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
It is currently under peer review with a first set of reviewers comments by the Journal of NeuroEngineering and Rehabilitation
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication
Intention to publish date
Participant level data
Basic results (scientific)