Virtual Rehabilitation Innovations for Motivation

NCT04430673 | Completed

• 1 other identifier: IRAS 275096
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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. 1.Whether commercially produced VR games can provide a motivating environment to support adherence to therapy
2. 2.Whether it is possible to improve reaching and grasp-release hand movements through this method
3. 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.

Conditions

Virtual Rehabilitation; CP (Cerebral Palsy); Brain Injuries; Young Adult; Children

Keywords

Virtual Rehabilitation; Cerebral palsy; Acquired brain injury; children and young people

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Phase 2: Daily over 2 weeks

Secondary Outcomes (2)

• Goal Attainment Scaling

  Phase 2: Day 1 and at 2-weeks (end of 2-week trial)

• Functional Reach Test

  Phase 2: Day 1 and at 2-weeks (end of 2-week trial)

Other Outcomes (2)

• Therapist diary of experiences

  Phase 2: Daily over 2 weeks

• Therapist diary of time

  Phase 2: Daily over 2 weeks

Study Arms (1)

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.

Other: Home-School based VR system trial

Interventions

Home-School based VR system trial OTHER

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.

Home-School based VR trial

Eligibility Criteria

• Age: 10 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• \) 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Free Hospital NHS Foundation Trust: lead
• Interreg: collaborator

Study Sites (1)

Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

Cerebral Palsy; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Research and Development Manager

  Research Sponsor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Action Research Proof of Concept study in 2-Phases. Phase 1, 2-hour workshop: Phase 2 2-week within subject trial.

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: June 12, 2020
• Study Start: February 22, 2021
• Primary Completion: May 30, 2021
• Study Completion: June 30, 2021
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)