Virtual Rehabilitation Innovations for Motivation (VR4REHAB-MOT)

May 10, 2022 updated by: Royal Free Hospital NHS Foundation Trust

VR4REHAB-MOTIVATION for REHABILITATION: Proof of Concept Evaluation of Virtual Reality Innovations for Therapy for Young People With Brain Injury

Children and young people with movement difficulties such as Cerebral Palsy (CP) and Acquired Brain Injury (ABI) report that traditional therapies are highly repetitive and labourious. This influences enjoyment and participation in regular therapy programmes and may result in reduced adherence to therapy or exercise regimes, limiting effectiveness. This study will build on the team's previous work to explore the potential use of Virtual-Reality (VR) technologies in rehabilitation; particularly systems that can be used at home to increase accessibility and reduce need to attend clinics for therapy. During the co-production events of the VR4REHAB Inter Regional North West Europe (NWE) funded programme in 2018, young people desired the use of commercial games for therapeutic purposes. This work has enabled connections between affordable computer technologies: the Raspberry Pi, VR headsets and freely available commercial games.

This 2-Phased project is therefore exploring the potential of commercially available virtual reality (VR) systems consoles and games for use in rehabilitation programmes. The Investigators hope to gain information on:

  1. Whether commercially produced VR games can provide a motivating environment to support adherence to therapy
  2. Whether it is possible to improve reaching and grasp-release hand movements through this method
  3. Gain an understanding of the ages of children and young people most likely to benefit from home-based VR therapy User evaluation and performance data and therapist evaluations will be collected and compared to baseline data to provide information on usability, accessibility, acceptability and adaptability.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Aim: The focus of this Proof-of-Concept feasibility study investigates the potential of commercially available virtual reality (VR) games and equipment for therapeutic use for upper limb rehabilitation; considering in particular the role of motivation and engagement when using the system to support adherence to therapy protocols.

Rationale - Effective rehabilitation requires appropriate dosage and intensity and be meaningful to daily life, but traditional therapeutic modalities struggle to achieve optimum input and gains following successful intensive intervention programmes are often not maintained. Commercial VR products are designed with high level gaming methods to engage participants in the games. Commercial VR products therefore offer potential as therapeutic adjuncts to gain appropriate practice of sufficient intensity and duration but may need some adjustments. Adjustments in this instance refer to changing the speed at which the game plays and which combinations of devices compliant with European Union standards (CE) can be connected.

The Investigators will evaluate whether young people with Cerebral Palsy (CP) or Acquired Brain injury (ABI) can be engaged in VR games for upper-limb movement using VR systems, potential for therapeutic benefit and also consider clinical feasibility in relation to utility, particularly in respect to the costs involved (i.e. labour, training, workplace set-up). The Co-Production Group (C-PG) group identified a 2-Phase study in order to assess for any modifiable alterations and prepare training manual prior to a short feasibility trial. This clinical trial is designed as an Action Research study in two Phases:

Phase 1 of the study. Participants will engage in a 2-hour workshop to test out the VR system and games in order to gather responses to the game speeds and devices (including method of access). Feedback will contribute to information for instruction leaflets for access and usability and determine whether further adjustments are required and additional training information needed for therapists to be able to set up the system to meet individual requirements. Information gathered during the workshop will also inform on the links and support required from the computer scientists for backup.

Phase 2 of the study, will test out the feasibility of use within a home/school setting as a Proof-of-Concept study. Phase 2, will inform on trial design for a larger randomized controlled trial. The VR system will be provided to each participant for a 2-week home- or school- based trial. User evaluation and performance data and therapist evaluations will be collected and compared to baseline data to provide information on usability, accessibility, acceptability and adaptability.

Evidence from preliminary, albeit small single-subject design studies, suggests that children and adults with movement impairments may improve upper limb performance (speed, fluency and accuracy) with some transfer to clinical measures of upper limb and hand skills. It is not known if children with CP/ABI can improve upper limb movement performance and function nor whether gains transfer into improved hand skills in daily life although it anticipated that benefits to function will be achieved for many children. An exploration of this point will be considered as secondary outcomes to inform on dose and duration for a future definitive clinical trial.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Royal Free London NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 30 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Bilateral and Unilateral CP or ABI with movement difficulties; Gross Motor Function Classification System (GMFCS) levels I to IV e.g. able to sit, independently operate electric wheelchair;
  2. Manual Ability Classification System (MACS) levels I to IV - able to move arms and hands and interact with some objects although adaptations may be needed to hold console/interfacing device such as use of velcro strap;
  3. Ability to follow simple task instruction;
  4. Aged 10 - 30 years; 5)) Ability to cooperate with assessment instructions.

6) Ability to give informed consent or assent if appropriate, participants having an acceptable individual capable of giving consent on the participant's behalf (e.g. parent or guardian of a child under 16 years of age)

  • Typically developed peers will need to meet criteria 3 to 6 and be eligible with respect to exclusion criteria.

Exclusion Criteria:

  1. Individuals who are GMFCS or MACS levels V; Inability to follow simple task instructions;
  2. less than 10 years or over 30 years;
  3. Individual with photosensitive epilepsy
  4. Unstable medical condition (in -patient status)
  5. Learning or behavior difficulties limiting ability to follow instructions or attend a 2 hour workshop/engage with a rehabilitation programme.
  6. Receiving Motor therapy treatment (eg. Botulinum Toxin Injections/A/Constraint Induced Movement Therapy or anticipated to receive such treatment during the 6 months of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Home-School based VR trial
The VR system will be provided to each participant for a 2-week home- or school- based trial. No additional interventions.
Other: Home-School based VR system trial
Commercially available VR games operated Raspberry pi micro computer and Oculus Quest VR headsets provided for 2 weeks at dose and intensity selected by participants.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
User Evaluation Questionnaire Form
Time Frame: Phase 2: 2-weeks (end of 2-week trial)
User evaluation (experience) questionnaire developed by the Co-production group. 15 closed questions rate aspects of accessibility and usability, enjoyment and relatedness and 5 open-ended questions for more personal feedback of experience, potential for use in rehabilitation and any recommended changes. Total scores will be computed with descriptive statistics recorded. Content and thematic analysis will be used to analyse data from open ended questions and considered with respect to the ratings provided by participants.
Phase 2: 2-weeks (end of 2-week trial)
Participant completed engagement diary
Time Frame: Phase 2: Daily over 2 weeks
Diaries of participants in which they note whether they chose or were prompted to use the game/system and record their experience of the session along with numbers of games played and reported duration of the session. Qualitative methods using content and thematic analysis will be used to analyse data to assist understanding of barriers or facilitators to user engagement.
Phase 2: Daily over 2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Goal Attainment Scaling
Time Frame: Phase 2: Day 1 and at 2-weeks (end of 2-week trial)
Patient reported outcomes using Goal Attainment Scaling will consider potential of system to address 3 identified child/young adult identified goals. Anticipated outcomes are defined on a 5 point scale with -2 = a much less than anticipated outcome; -1= less than anticipated outcome; 0=anticipated outcome; +1 =better than expected outcome; +2=much better than expected outcome. Each goal is weighted by asking the participant to rank them in order of importance and also with respect to anticipated difficulty on a four point scale and a total weigh/per goal determined by multiplying Importance x difficulty=weight of goal. The outcome score for each goal is rated at the review data and the goal attainment 'T-score' calculated using the formula and calculation provided in Turner Stokes (2006) which takes into consideration the sum of weights and score changes and expected correlations. HIgher scores reflect better outcome.
Phase 2: Day 1 and at 2-weeks (end of 2-week trial)
Functional Reach Test
Time Frame: Phase 2: Day 1 and at 2-weeks (end of 2-week trial)
Functional Reach test measures extent of forward reach of each arm in centimetres while maintaining balance. Larger distance is better function.
Phase 2: Day 1 and at 2-weeks (end of 2-week trial)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Therapist diary of experiences
Time Frame: Phase 2: Daily over 2 weeks
Research therapists will record the type of support provided to participants, training requirements and their opinion as to whether the system supported therapeutic objectives in order to consider feasibility of delivery. Comments will be analysed qualitatively to understand the types of support and/or refinements to the system set up or information required for participants to use the system at home.
Phase 2: Daily over 2 weeks
Therapist diary of time
Time Frame: Phase 2: Daily over 2 weeks
Research therapists and level of experience/salary banding will record the amount of time provided to participants and any additional training time. Total time will be calculated to determine potential cost to support home-based use of VR systems.
Phase 2: Daily over 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Royal Free Hospital NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Interreg

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Research and Development Manager, Research Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRAS 275096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a small study involving qualitative feedback and releasing individual data would risk contributing to misleading interpretations if added to a larger data set.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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