Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Brain Injuries
  • Children
  • CP (Cerebral Palsy)
  • Virtual Rehabilitation
  • Young Adult
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention 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)Primary Purpose: Treatment

Participation Requirements

Age
Between 10 years and 30 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT04430673
Collaborators
Interreg
Investigators
Study Chair: Research and Development Manager Research Sponsor