<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04430673</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS 275096</org_study_id>
    <nct_id>NCT04430673</nct_id>
  </id_info>
  <brief_title>Virtual Rehabilitation Innovations for Motivation</brief_title>
  <acronym>VR4REHAB-MOT</acronym>
  <official_title>VR4REHAB-MOTIVATION for REHABILITATION: Proof of Concept Evaluation of Virtual Reality Innovations for Therapy for Young People With Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Free Hospital NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Interreg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Royal Free Hospital NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Children and young people with movement difficulties such as Cerebral Palsy (CP) and Acquired&#xD;
      Brain Injury (ABI) report that traditional therapies are highly repetitive and labourious.&#xD;
      This influences enjoyment and participation in regular therapy programmes and may result in&#xD;
      reduced adherence to therapy or exercise regimes, limiting effectiveness. This study will&#xD;
      build on the team's previous work to explore the potential use of Virtual-Reality (VR)&#xD;
      technologies in rehabilitation; particularly systems that can be used at home to increase&#xD;
      accessibility and reduce need to attend clinics for therapy. During the co-production events&#xD;
      of the VR4REHAB Inter Regional North West Europe (NWE) funded programme in 2018, young people&#xD;
      desired the use of commercial games for therapeutic purposes. This work has enabled&#xD;
      connections between affordable computer technologies: the Raspberry Pi, VR headsets and&#xD;
      freely available commercial games.&#xD;
&#xD;
      This 2-Phased project is therefore exploring the potential of commercially available virtual&#xD;
      reality (VR) systems consoles and games for use in rehabilitation programmes. The&#xD;
      Investigators hope to gain information on:&#xD;
&#xD;
        1. Whether commercially produced VR games can provide a motivating environment to support&#xD;
           adherence to therapy&#xD;
&#xD;
        2. Whether it is possible to improve reaching and grasp-release hand movements through this&#xD;
           method&#xD;
&#xD;
        3. Gain an understanding of the ages of children and young people most likely to benefit&#xD;
           from home-based VR therapy User evaluation and performance data and therapist&#xD;
           evaluations will be collected and compared to baseline data to provide information on&#xD;
           usability, accessibility, acceptability and adaptability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim: The focus of this Proof-of-Concept feasibility study investigates the potential of&#xD;
      commercially available virtual reality (VR) games and equipment for therapeutic use for upper&#xD;
      limb rehabilitation; considering in particular the role of motivation and engagement when&#xD;
      using the system to support adherence to therapy protocols.&#xD;
&#xD;
      Rationale - Effective rehabilitation requires appropriate dosage and intensity and be&#xD;
      meaningful to daily life, but traditional therapeutic modalities struggle to achieve optimum&#xD;
      input and gains following successful intensive intervention programmes are often not&#xD;
      maintained. Commercial VR products are designed with high level gaming methods to engage&#xD;
      participants in the games. Commercial VR products therefore offer potential as therapeutic&#xD;
      adjuncts to gain appropriate practice of sufficient intensity and duration but may need some&#xD;
      adjustments. Adjustments in this instance refer to changing the speed at which the game plays&#xD;
      and which combinations of devices compliant with European Union standards (CE) can be&#xD;
      connected.&#xD;
&#xD;
      The Investigators will evaluate whether young people with Cerebral Palsy (CP) or Acquired&#xD;
      Brain injury (ABI) can be engaged in VR games for upper-limb movement using VR systems,&#xD;
      potential for therapeutic benefit and also consider clinical feasibility in relation to&#xD;
      utility, particularly in respect to the costs involved (i.e. labour, training, workplace&#xD;
      set-up). The Co-Production Group (C-PG) group identified a 2-Phase study in order to assess&#xD;
      for any modifiable alterations and prepare training manual prior to a short feasibility&#xD;
      trial. This clinical trial is designed as an Action Research study in two Phases:&#xD;
&#xD;
      Phase 1 of the study. Participants will engage in a 2-hour workshop to test out the VR system&#xD;
      and games in order to gather responses to the game speeds and devices (including method of&#xD;
      access). Feedback will contribute to information for instruction leaflets for access and&#xD;
      usability and determine whether further adjustments are required and additional training&#xD;
      information needed for therapists to be able to set up the system to meet individual&#xD;
      requirements. Information gathered during the workshop will also inform on the links and&#xD;
      support required from the computer scientists for backup.&#xD;
&#xD;
      Phase 2 of the study, will test out the feasibility of use within a home/school setting as a&#xD;
      Proof-of-Concept study. Phase 2, will inform on trial design for a larger randomized&#xD;
      controlled trial. The VR system will be provided to each participant for a 2-week home- or&#xD;
      school- based trial. User evaluation and performance data and therapist evaluations will be&#xD;
      collected and compared to baseline data to provide information on usability, accessibility,&#xD;
      acceptability and adaptability.&#xD;
&#xD;
      Evidence from preliminary, albeit small single-subject design studies, suggests that children&#xD;
      and adults with movement impairments may improve upper limb performance (speed, fluency and&#xD;
      accuracy) with some transfer to clinical measures of upper limb and hand skills. It is not&#xD;
      known if children with CP/ABI can improve upper limb movement performance and function nor&#xD;
      whether gains transfer into improved hand skills in daily life although it anticipated that&#xD;
      benefits to function will be achieved for many children. An exploration of this point will be&#xD;
      considered as secondary outcomes to inform on dose and duration for a future definitive&#xD;
      clinical trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 22, 2021</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">May 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Action Research Proof of Concept study in 2-Phases. Phase 1, 2-hour workshop: Phase 2 2-week within subject trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>User Evaluation Questionnaire Form</measure>
    <time_frame>Phase 2: 2-weeks (end of 2-week trial)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant completed engagement diary</measure>
    <time_frame>Phase 2: Daily over 2 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Goal Attainment Scaling</measure>
    <time_frame>Phase 2: Day 1 and at 2-weeks (end of 2-week trial)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Reach Test</measure>
    <time_frame>Phase 2: Day 1 and at 2-weeks (end of 2-week trial)</time_frame>
    <description>Functional Reach test measures extent of forward reach of each arm in centimetres while maintaining balance. Larger distance is better function.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Therapist diary of experiences</measure>
    <time_frame>Phase 2: Daily over 2 weeks</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Therapist diary of time</measure>
    <time_frame>Phase 2: Daily over 2 weeks</time_frame>
    <description>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.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Virtual Rehabilitation</condition>
  <condition>CP (Cerebral Palsy)</condition>
  <condition>Brain Injuries</condition>
  <condition>Young Adult</condition>
  <condition>Children</condition>
  <arm_group>
    <arm_group_label>Home-School based VR trial</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The VR system will be provided to each participant for a 2-week home- or school- based trial. No additional interventions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home-School based VR system trial</intervention_name>
    <description>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.</description>
    <arm_group_label>Home-School based VR trial</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Bilateral and Unilateral CP or ABI with movement difficulties; Gross Motor Function&#xD;
             Classification System (GMFCS) levels I to IV e.g. able to sit, independently operate&#xD;
             electric wheelchair;&#xD;
&#xD;
          2. Manual Ability Classification System (MACS) levels I to IV - able to move arms and&#xD;
             hands and interact with some objects although adaptations may be needed to hold&#xD;
             console/interfacing device such as use of velcro strap;&#xD;
&#xD;
          3. Ability to follow simple task instruction;&#xD;
&#xD;
          4. Aged 10 - 30 years; 5)) Ability to cooperate with assessment instructions.&#xD;
&#xD;
        6) Ability to give informed consent or assent if appropriate, participants having an&#xD;
        acceptable individual capable of giving consent on the participant's behalf (e.g. parent or&#xD;
        guardian of a child under 16 years of age)&#xD;
&#xD;
          -  Typically developed peers will need to meet criteria 3 to 6 and be eligible with&#xD;
             respect to exclusion criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Individuals who are GMFCS or MACS levels V; Inability to follow simple task&#xD;
             instructions;&#xD;
&#xD;
          2. less than 10 years or over 30 years;&#xD;
&#xD;
          3. Individual with photosensitive epilepsy&#xD;
&#xD;
          4. Unstable medical condition (in -patient status)&#xD;
&#xD;
          5. Learning or behavior difficulties limiting ability to follow instructions or attend a&#xD;
             2 hour workshop/engage with a rehabilitation programme.&#xD;
&#xD;
          6. Receiving Motor therapy treatment (eg. Botulinum Toxin Injections/A/Constraint Induced&#xD;
             Movement Therapy or anticipated to receive such treatment during the 6 months of the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Research and Development Manager</last_name>
    <role>Study Chair</role>
    <affiliation>Research Sponsor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Free London NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>April 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>May 10, 2022</last_update_submitted>
  <last_update_submitted_qc>May 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Virtual Rehabilitation</keyword>
  <keyword>Cerebral palsy</keyword>
  <keyword>Acquired brain injury</keyword>
  <keyword>children and young people</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04430673
org study id: IRAS 275096
nct id: NCT04430673
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Action Research Proof of Concept study in 2-Phases. Phase 1, 2-hour workshop: Phase 2 2-week within subject trial.
primary purpose: Treatment
masking: None (Open Label)
measure: User Evaluation Questionnaire Form
time frame: Phase 2: 2-weeks (end of 2-week trial)
description: 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.
measure: Participant completed engagement diary
time frame: Phase 2: Daily over 2 weeks
description: 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.
measure: Goal Attainment Scaling
time frame: Phase 2: Day 1 and at 2-weeks (end of 2-week trial)
description: 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.
measure: Functional Reach Test
time frame: Phase 2: Day 1 and at 2-weeks (end of 2-week trial)
description: Functional Reach test measures extent of forward reach of each arm in centimetres while maintaining balance. Larger distance is better function.
measure: Therapist diary of experiences
time frame: Phase 2: Daily over 2 weeks
description: 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.
measure: Therapist diary of time
time frame: Phase 2: Daily over 2 weeks
description: 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.
arm group label: Home-School based VR trial
arm group type: Experimental
description: The VR system will be provided to each participant for a 2-week home- or school- based trial. No additional interventions.
intervention type: Other
intervention name: Home-School based VR system trial
description: 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.
arm group label: Home-School based VR trial
criteria: 
gender: All
minimum age: 10 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Research and Development Manager
role: Study Chair
affiliation: Research Sponsor
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Cerebral Palsy
sharing ipd: No
ipd 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.