Clinical trial NCT03766711: VR Error Augmentation for Bimanual Task Exercise
Official title: FEATHERS 2.0: Functional Engagement in Assistive Therapy Through Exercise Robotics v2.0
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiparesis
Cerebral Palsy
Acquired Brain Injury
Keywords: Bimanual Task
Motor Adaptation
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Kids Brain Health Network
First posted: 2018-12-06
Enrollment: 5
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This project is a continuing study from the FEATHERS project (NCT02290353) which focuses on developing novel home therapy program for persons with hemiparesis. This study will focus on examining motor behaviour and adaptation in neurodevelopmental hemiparesis (cerebral palsy, acquired brain injury (ABI)). New algorithms for motion control involved in encouraging active movement are developed and will be tested, but the study has the same therapeutic goal and focus as the original FEATHERS project of creating an engaging at-home bimanual upper limb training program. By incorporating existing gaming technology, we hope to discover novel ways to adapt commercial motion tracking controllers and visual feedback into engaging rehabilitative learning tools. This study will focus on a basic science aspect of human bimanual movements that can be incorporated into future applications of the full FEATHERS project devices. We believe that together these approaches will yield interventions that significantly improve functional ability and lead to improved quality of life.

Detailed description: (Main Phase Only - Data Collected with Clinical Population)

The FEATHERS project at the RREACH Lab at The University of British Columbia focuses on developing and evaluating novel physical exercise technologies for kids with motor disabilities. The study team would like to study how immersive virtual reality (VR) technology can be used to benefit upper limb rehabilitation for persons with hemiplegia. The purpose of the experiment is to see how the use of error augmentation (i.e. adding visual or game element feedback to accentuate deviation from the desired exercise motion) might encourage persons with hemiplegia to engage their affected side more effectively by comparing the symmetry between the stronger and weaker limbs. It is also hypothesized that the immersive environment of VR and the ability to provide 1:1 direct visual feedback will increase active engagement to rehabilitative exercises in these populations. The study will address the question of whether error augmentation aids in the rehabilitation of the affected upper limb movement quality in hemiparesis when practicing bilateral reaching tasks. Specifically, can visual amplification of paretic asymmetry in an immersive VR environment improve movement quality in the affected side?

Adolescents and young adults with hemiplegia (i.e. due to ABI, CP, etc.) and their adjoining therapists will be recruited for from the community. We will conduct testing in a single-session setup at the participant chosen location with an easily transportable system including a standard 2-3 sensor Oculus system hardware setup and software developed by the research team. Sessions conducted outside the research lab rooms will require a minimum of a 2m x 1.5m space for calibration. The participants will test all augmentation factors in a randomized order and the sessions are expected to take between 90-120 minutes. A short post-session usability survey will be administered and sample population demographic data will be recorded including age, gender, and handedness. Manual Ability Classification System (MACS) and Bimanual Fine Motor Function (BFMF) scores will be recorded or assessed to classify the upper limb motor ability of the sample set.

Eligibility criteria: Inclusion for adolescents and young adults (ages 13-21 years) :

i. Hemiplegia as a result of a neurological impairment (CP, ABI, paediatric stroke, etc.)

ii. Use both eyes and visually interact using a stereoscopic device that allows a minimum interpupillary distance of 58mm

iii. Comfortably support regular head motion while wearing a 470g head-mounted display

iv. Ability to lift arms against gravity at least some distance away from their body (some shoulder and elbow flexion and extension) as reported by participant, consenting guardian, or adjoining therapist

v. Ability to stand or sit independently for 15 minutes at a time in a chair without arm supports for a total of up to 120 minutes

vi. Ability to follow instructions and verbally communicate in basic English (as determined by referring therapist)

Exclusion Criteria:

i. Upper limb orthopedic surgery in the past six months

ii. Known susceptibility to cybersickness

Primary outcomes:
measure: Change in Error in Forward Reaching Symmetry
timeFrame: Recorded per reach, throughout the session (about 2 hours)
Secondary outcomes:
measure: Distance traveled of each arm from head
timeFrame: Recorded per reach, throughout the session (about 2 hours)
measure: Time to complete task
timeFrame: Recorded per reach, throughout the session (about 2 hours)
measure: Movement Smoothness
timeFrame: Recorded per arm, per reach, throughout the session (about 2 hours)
measure: Change in Error in Forward Reaching Symmetry Over Time
timeFrame: Recorded per reach, throughout the session (about 2 hours)
measure: Compensation Techniques Causing Joint Asymmetry
timeFrame: Recorded throughout the session (about 2 hours)
measure: Trunk Compensation
timeFrame: Recorded throughout the session (about 2 hours)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Physiotherapy, BC Children's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: RREACH Lab, The University of British Columbia
state: British Columbia
Study officials:
affiliation: The University of British Columbia
name: Hendrik FM Van der Loos, PhD, P.Eng
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shum LC, Valdes BA, Hodges NJ, Van der Loos HFM. Error Augmentation in Immersive Virtual Reality for Bimanual Upper-Limb Rehabilitation in Individuals With and Without Hemiplegic Cerebral Palsy. IEEE Trans Neural Syst Rehabil Eng. 2020 Feb;28(2):541-549. doi: 10.1109/TNSRE.2019.2959621. Epub 2019 Dec 13.