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Completed

NCT Number: NCT03766711

VR Error Augmentation for Bimanual Task Exercise

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.

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Key information

Age range

13 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physiotherapy, BC Children's Hospital, Vancouver, British Columbia, Canada

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About this study

(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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Therapy

Other

Repetitive bimanual task training for upper limb motor function recovery.

Primary outcomes

  1. Change in Error in Forward Reaching Symmetry

    Time frame: Recorded per reach, throughout the session (about 2 hours)

    Compared between each condition (in cm, % change from baseline)

Secondary outcomes

  1. Distance traveled of each arm from head

    Time frame: Recorded per reach, throughout the session (about 2 hours)

    Change in position in cm of the participant hands from the start to end of the reach trial

  2. Time to complete task

    Time frame: Recorded per reach, throughout the session (about 2 hours)

    Time in seconds from the start to the end of the reach trial

  3. Movement Smoothness

    Time frame: Recorded per arm, per reach, throughout the session (about 2 hours)

    Deviation from linear path in the lateral direction and number of peaks in forward velocity profile

  4. Change in Error in Forward Reaching Symmetry Over Time

    Time frame: Recorded per reach, throughout the session (about 2 hours)

    Change in error throughout each set during the learning conditions

  5. Compensation Techniques Causing Joint Asymmetry

    Time frame: Recorded throughout the session (about 2 hours)

    Maximum difference in cm in contralateral joint position in the upper body (shoulder y, z)

  6. Trunk Compensation

    Time frame: Recorded throughout the session (about 2 hours)

    Change in forward position in cm of the participant head and trunk (mid-shoulder point) during reaching movement

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Kids Brain Health Network

Registry information

Official study title

FEATHERS 2.0: Functional Engagement in Assistive Therapy Through Exercise Robotics v2.0

Acronym: FEATHERSv2

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 6, 2018
Registry last updated
Nov 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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