Condition category
Nervous System Diseases
Date applied
29/07/2019
Date assigned
01/08/2019
Last edited
01/08/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.neurojungle.com

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

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

http://www.neurojungle.com

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)

Active range of motion (AROM) of shoulder, elbow and wrist improved in all three groups. VBM revealed grey matter increase in five brain areas: the tail of hippocampus, left caudate, rostral cingulate zone, depth of central sulcus and visual cortex. Positive correlation between grey matter volumes in three cortical regions (precentral gyrus, Brodmann area 6, supplementary motor area) and motor test results (power and AROM) were detected.

Publication list

Publication citations

Additional files

Editorial Notes

01/08/2019: Trial’s existence confirmed by Ethics Board of Rehabilitation Centre Kladruby. The ethics approval was added.