VR Error Augmentation for Bimanual Task Exercise

Cerebral Palsy Clinical Trial

— FEATHERSv2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03766711
• Other study ID #: H17-01126
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: September 24, 2019

Study information

• Verified date: October 2020
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 24, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Cerebral Palsy
• Hemiparesis
• Paresis

Intervention

Other:
• Physical Therapy
Repetitive bimanual task training for upper limb motor function recovery.

Locations

Country	Name	City	State
Canada	Physiotherapy, BC Children's Hospital	Vancouver	British Columbia
Canada	RREACH Lab, The University of British Columbia	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Kids Brain Health Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)