NCT03766711

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2019

Completed
Last Updated

November 2, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

December 5, 2018

Last Update Submit

October 29, 2020

Conditions

Keywords

Bimanual TaskMotor Adaptation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Distance traveled of each arm from head

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

  • Time to complete task

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

  • Movement Smoothness

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

  • Change in Error in Forward Reaching Symmetry Over Time

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

  • Compensation Techniques Causing Joint Asymmetry

    Recorded throughout the session (about 2 hours)

  • +1 more secondary outcomes

Study Arms (2)

Actual - Augmented

EXPERIMENTAL

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

Other: Physical Therapy

Augmented - Actual

EXPERIMENTAL

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

Other: Physical Therapy

Interventions

Repetitive bimanual task training for upper limb motor function recovery.

Actual - AugmentedAugmented - Actual

Eligibility Criteria

Age13 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • i. Upper limb orthopedic surgery in the past six months
  • ii. Known susceptibility to cybersickness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Physiotherapy, BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

RREACH Lab, The University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

ParesisCerebral PalsyBrain Injuries

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Hendrik FM Van der Loos, PhD, P.Eng

    The University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Dept. Mechanical Engineering

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 6, 2018

Study Start

January 10, 2018

Primary Completion

March 30, 2019

Study Completion

September 24, 2019

Last Updated

November 2, 2020

Record last verified: 2020-10

Locations