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VR Error Augmentation for Bimanual Task Exercise (FEATHERSv2)

Primary Purpose

Hemiparesis, Cerebral Palsy, Acquired Brain Injury

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Physical Therapy
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hemiparesis focused on measuring Bimanual Task, Motor Adaptation

Eligibility Criteria

13 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Physiotherapy, BC Children's Hospital
  • RREACH Lab, The University of British Columbia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Actual - Augmented

Augmented - Actual

Arm Description

Reaching task as a physical therapy intervention. First with 1:1 visual feedback, then with augmented forward symmetry.

Reaching task as a physical therapy intervention. First with augmented forward symmetry, then with 1:1 visual feedback.

Outcomes

Primary Outcome Measures

Change in Error in Forward Reaching Symmetry
Compared between each condition (in cm, % change from baseline)

Secondary Outcome Measures

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

Full Information

First Posted
December 5, 2018
Last Updated
October 29, 2020
Sponsor
University of British Columbia
Collaborators
Kids Brain Health Network
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1. Study Identification

Unique Protocol Identification Number
NCT03766711
Brief Title
VR Error Augmentation for Bimanual Task Exercise
Acronym
FEATHERSv2
Official Title
FEATHERS 2.0: Functional Engagement in Assistive Therapy Through Exercise Robotics v2.0
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
September 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Kids Brain Health Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis, Cerebral Palsy, Acquired Brain Injury
Keywords
Bimanual Task, Motor Adaptation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
Participant intervention arm will be randomized and they will not be told which whether the treatment is being applied in the current set. However, they will be instructed of the task goal at the beginning of the session and will be told that we will be modifying visual feedback to help improve reaching symmetry in some manner.
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Actual - Augmented
Arm Type
Experimental
Arm Description
Reaching task as a physical therapy intervention. First with 1:1 visual feedback, then with augmented forward symmetry.
Arm Title
Augmented - Actual
Arm Type
Experimental
Arm Description
Reaching task as a physical therapy intervention. First with augmented forward symmetry, then with 1:1 visual feedback.
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Intervention Description
Repetitive bimanual task training for upper limb motor function recovery.
Primary Outcome Measure Information:
Title
Change in Error in Forward Reaching Symmetry
Description
Compared between each condition (in cm, % change from baseline)
Time Frame
Recorded per reach, throughout the session (about 2 hours)
Secondary Outcome Measure Information:
Title
Distance traveled of each arm from head
Description
Change in position in cm of the participant hands from the start to end of the reach trial
Time Frame
Recorded per reach, throughout the session (about 2 hours)
Title
Time to complete task
Description
Time in seconds from the start to the end of the reach trial
Time Frame
Recorded per reach, throughout the session (about 2 hours)
Title
Movement Smoothness
Description
Deviation from linear path in the lateral direction and number of peaks in forward velocity profile
Time Frame
Recorded per arm, per reach, throughout the session (about 2 hours)
Title
Change in Error in Forward Reaching Symmetry Over Time
Description
Change in error throughout each set during the learning conditions
Time Frame
Recorded per reach, throughout the session (about 2 hours)
Title
Compensation Techniques Causing Joint Asymmetry
Description
Maximum difference in cm in contralateral joint position in the upper body (shoulder y, z)
Time Frame
Recorded throughout the session (about 2 hours)
Title
Trunk Compensation
Description
Change in forward position in cm of the participant head and trunk (mid-shoulder point) during reaching movement
Time Frame
Recorded throughout the session (about 2 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hendrik FM Van der Loos, PhD, P.Eng
Organizational Affiliation
The University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physiotherapy, BC Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
RREACH Lab, The University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
31841417
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.
Results Reference
derived

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VR Error Augmentation for Bimanual Task Exercise

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