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?
Vincent Macri,
vjm@vincemacri.us
Trial website
Contact information
Type
Public
Primary contact
Mr Vincent Macri
ORCID ID
Contact details
434 Lacy Woods Court
Tallahassee
32312
United States of America
603-502-6068
vjm@vincemacri.us
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
001-1
Study information
Scientific title
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
Acronym
PAGEs
Study hypothesis
Stroke survivors controlling virtual limbs will improve functional use of impaired limbs and experience cortical grey matter change
Ethics approval
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.
Study design
Interventional randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Ischemic stroke and traumatic brain injury
Intervention
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.
Intervention type
Other
Phase
Drug names
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
None
Overall trial start date
10/12/2014
Overall trial end date
30/04/2015
Reason abandoned (if study stopped)
Eligibility
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
35
Total final enrolment
35
Participant exclusion criteria
1. Patients unable to comprehend use of standard computer mouse to point to and control virtual limbs
Recruitment start date
10/01/2015
Recruitment end date
31/01/2015
Locations
Countries of recruitment
Czech Republic
Trial participating centre
Kladruby Rehabilitation Facility
Kladruby
349 61
Czech Republic
Sponsor information
Organisation
3DPreMotorSkills, LLC
Sponsor details
434 Lacy Woods Court
Tallahassee
32312
United States of America
603-502-6068
vjm@vincemacri.us
Sponsor type
Research organisation
Website
Funders
Funder type
Industry
Funder name
3DPreMotorSkills, LLC
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
01/09/2019
Participant level data
Other
Basic results (scientific)
Publication list
2020 results in https://pubmed.ncbi.nlm.nih.gov/32919473/ (added 15/09/2020)