VR Error Augmentation for Bimanual Task Exercise (FEATHERSv2)

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Acquired Brain Injury; Hemiparesis
• Intervention / Treatment: Other: Physical Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3V4
      • Physiotherapy, BC Children's Hospital
    • Vancouver, British Columbia, Canada, V6T 1Z4
      • RREACH Lab, The University of British Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Actual - Augmented; Reaching task as a physical therapy intervention. First with 1:1 visual feedback, then with augmented forward symmetry.	Other: Physical Therapy; Repetitive bimanual task training for upper limb motor function recovery.
EXPERIMENTAL: Augmented - Actual; Reaching task as a physical therapy intervention. First with augmented forward symmetry, then with 1:1 visual feedback.	Other: Physical Therapy; Repetitive bimanual task training for upper limb motor function recovery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Error in Forward Reaching Symmetry	Compared between each condition (in cm, % change from baseline)	Recorded per reach, throughout the session (about 2 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance traveled of each arm from head	Change in position in cm of the participant hands from the start to end of the reach trial	Recorded per reach, throughout the session (about 2 hours)
Time to complete task	Time in seconds from the start to the end of the reach trial	Recorded per reach, throughout the session (about 2 hours)
Movement Smoothness	Deviation from linear path in the lateral direction and number of peaks in forward velocity profile	Recorded per arm, per reach, throughout the session (about 2 hours)
Change in Error in Forward Reaching Symmetry Over Time	Change in error throughout each set during the learning conditions	Recorded per reach, throughout the session (about 2 hours)
Compensation Techniques Causing Joint Asymmetry	Maximum difference in cm in contralateral joint position in the upper body (shoulder y, z)	Recorded throughout the session (about 2 hours)
Trunk Compensation	Change in forward position in cm of the participant head and trunk (mid-shoulder point) during reaching movement	Recorded throughout the session (about 2 hours)

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Kids Brain Health Network
• Investigators: Principal Investigator: Hendrik FM Van der Loos, PhD, P.Eng, The University of British Columbia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2018
• Primary Completion (ACTUAL): March 30, 2019
• Study Completion (ACTUAL): September 24, 2019

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (ACTUAL): December 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Bimanual Task; Motor Adaptation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Brain Damage, Chronic; Craniocerebral Trauma; Trauma, Nervous System; Cerebral Palsy; Brain Injuries; Paresis
• Other Study ID Numbers: H17-01126

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No