Limitations of motor brain activity – use of virtual reality for simulation of therapeutic interventions
| ISRCTN | ISRCTN11757651 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11757651 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 001-1 |
| Sponsor | 3DPreMotorSkills, LLC |
| Funder | 3DPreMotorSkills, LLC |
- 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
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
Contact information
Public
434 Lacy Woods Court
Tallahassee
32312
United States of America
| Phone | 603-502-6068 |
|---|---|
| vjm@vincemacri.us |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | PAGEs |
| Study objectives | Stroke 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) studied | 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 |
| Primary outcome measure(s) |
Measured at baseline (1-3 days before intervention) and post-intervention (10-weeks). |
| Key secondary outcome measure(s) |
None |
| Completion date | 30/04/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 35 |
| Total final enrolment | 35 |
| Key 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 |
| Key exclusion criteria | 1. Patients unable to comprehend use of standard computer mouse to point to and control virtual limbs |
| Date of first enrolment | 10/01/2015 |
| Date of final enrolment | 31/01/2015 |
Locations
Countries of recruitment
- Czech Republic
Study participating centre
349 61
Czech Republic
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | All 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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.
