Virtual RehabilitationVR4REHAB-MOTNCT04430673
Virtual Rehabilitation Innovations for Motivation
A study testing Home-School based VR system trial in people with Virtual Rehabilitation and CP (Cerebral Palsy), run by Royal Free Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Rehabilitation, CP (Cerebral Palsy), Brain Injuries
- What is being tested?
- Home-School based VR system trial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Feb 2021to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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;
- 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;
- Ability to follow simple task instruction;
- 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.
Who cannot join
- Individuals who are GMFCS or MACS levels V; Inability to follow simple task instructions;
- less than 10 years or over 30 years;
- Individual with photosensitive epilepsy
- Unstable medical condition (in -patient status)
- Learning or behavior difficulties limiting ability to follow instructions or attend a 2 hour workshop/engage with a rehabilitation programme.
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Free London NHS Foundation Trust
London, NW3 2QG
About this study
Official title: 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:
- Whether commercially produced VR games can provide a motivating environment to support adherence to therapy
- Whether it is possible to improve reaching and grasp-release hand movements through this method
- 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.
Read the 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.
- Being tested
- Home-School based VR system trial
- Keywords
- Virtual Rehabilitation, Cerebral palsy, Acquired brain injury, children and young people
- Medical subject headings
- Cerebral Palsy, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-School based VR system trialOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Home-School based VR trial | Experimental | The VR system will be provided to each participant for a 2-week home- or school- based trial. No additional interventions. Receives: Other: Home-School based VR system trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
User Evaluation Questionnaire Form
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.
Measured: Phase 2: 2-weeks (end of 2-week trial)
Participant completed engagement diary
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.
Measured: Phase 2: Daily over 2 weeks
Secondary outcomes (2)
Goal Attainment Scaling
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.
Measured: Phase 2: Day 1 and at 2-weeks (end of 2-week trial)
Functional Reach Test
Functional Reach test measures extent of forward reach of each arm in centimetres while maintaining balance. Larger distance is better function.
Measured: Phase 2: Day 1 and at 2-weeks (end of 2-week trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start22 Feb 2021
- Primary completion30 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Action Research Proof of Concept study in 2-Phases. Phase 1, 2-hour workshop: Phase 2 2-week within subject trial.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Free Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Interreg
- Responsible party
- Sponsor
- Investigators
- Research and Development Manager, Study chair, Research Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430673
- Sponsor's protocol ID
- IRAS 275096
- Acronym
- VR4REHAB-MOT
- Status last verified
- May 2022
- First submitted
- 22 Apr 2020
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VR4REHAB-MOTIVATION for REHABILITATION: Proof of Concept Evaluation of Virtual Reality Innovations for Therapy for Young People With Brain Injury
- ClinicalTrials.gov ID
- NCT04430673
- Acronym / sponsor ID
- VR4REHAB-MOT / IRAS 275096
- Keywords
- Virtual Rehabilitation, Cerebral palsy, Acquired brain injury, children and young people
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Royal Free Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Interreg
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Whether commercially produced VR games can provide a motivating environment to support adherence to therapy
- Whether it is possible to improve reaching and grasp-release hand movements through this method
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Action Research Proof of Concept study in 2-Phases. Phase 1, 2-hour workshop: Phase 2 2-week within subject trial.
| Arm | Type | Receives |
|---|---|---|
| Home-School based VR trial | Experimental | Other: Home-School based VR system trialThe VR system will be provided to each participant for a 2-week home- or school- based trial. No additional interventions. |
Who may qualify
- Ages
- 10 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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;
- 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;
- Ability to follow simple task instruction;
- 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)
Key exclusion criteria (6 listed)
- Individuals who are GMFCS or MACS levels V; Inability to follow simple task instructions;
- less than 10 years or over 30 years;
- Individual with photosensitive epilepsy
- Unstable medical condition (in -patient status)
- Learning or behavior difficulties limiting ability to follow instructions or attend a 2 hour workshop/engage with a rehabilitation programme.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-School based VR system trialCommercially available VR games operated Raspberry pi micro computer and Oculus Quest VR headsets provided for 2 weeks at dose and intensity selected by participants. | Other | Home-School based VR trial |
Primary outcome
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.
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.
2 secondary outcomes
Goal Attainment Scaling
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Research and Development Manager study chair
Research Sponsor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-School based VR system trial in people with Virtual Rehabilitation and CP (Cerebral Palsy), run by Royal Free Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User Evaluation Questionnaire Form (time frame: Phase 2: 2-weeks (end of 2-week trial)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.