HemiparesisFEATHERSv2NCT03766711
VR Error Augmentation for Bimanual Task Exercise
A study testing Physical Therapy in people with Hemiparesis and Cerebral Palsy, run by University of British Columbia at 2 sites in Canada.
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)). Read more about this study
- Who is it for?
- Ages 13 to 21 years
- Conditions the study is for
- Hemiparesis, Cerebral Palsy, Acquired Brain Injury
- What is being tested?
- Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesCanada
- Study dates
- 10 Jan 2018to 24 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Upper limb orthopedic surgery in the past six months
- Known susceptibility to cybersickness
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Physiotherapy, BC Children's Hospital
Vancouver, British Columbia, V6H 3V4
RREACH Lab, The University of British Columbia
Vancouver, British Columbia, V6T 1Z4
About this study
Official title: 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.
Read the 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.
- Conditions
- Hemiparesis, Cerebral Palsy, Acquired Brain Injury
- Being tested
- Physical Therapy
- Keywords
- Bimanual Task, Motor Adaptation
- Medical subject headings
- Paresis, Cerebral Palsy, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
Repetitive bimanual task training for upper limb motor function recovery.
| Study group | Role | What they receive |
|---|---|---|
| Actual - Augmented | Experimental | Reaching task as a physical therapy intervention. First with 1:1 visual feedback, then with augmented forward symmetry. Receives: Other: Physical Therapy |
| Augmented - Actual | Experimental | Reaching task as a physical therapy intervention. First with augmented forward symmetry, then with 1:1 visual feedback. Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Error in Forward Reaching Symmetry
Compared between each condition (in cm, % change from baseline)
Measured: Recorded per reach, throughout the session (about 2 hours)
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: Recorded throughout the session (about 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start10 Jan 2018
- Primary completion30 Mar 2019
- Study completion24 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemiparesisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Kids Brain Health Network
- Responsible party
- Principal investigator, Hendrik F. Machiel Van der Loos, University of British Columbia
- Investigators
- Hendrik FM Van der Loos, PhD, P.Eng, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766711
- Sponsor's protocol ID
- H17-01126
- Acronym
- FEATHERSv2
- Status last verified
- Oct 2020
- First submitted
- 5 Dec 2018
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31841417
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FEATHERS 2.0: Functional Engagement in Assistive Therapy Through Exercise Robotics v2.0
- ClinicalTrials.gov ID
- NCT03766711
- Acronym / sponsor ID
- FEATHERSv2 / H17-01126
- Conditions
- Hemiparesis, Cerebral Palsy, Acquired Brain Injury
- Keywords
- Bimanual Task, Motor Adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Kids Brain Health Network
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Actual - Augmented | Experimental | Other: Physical TherapyReaching task as a physical therapy intervention. First with 1:1 visual feedback, then with augmented forward symmetry. |
| Augmented - Actual | Experimental | Other: Physical TherapyReaching task as a physical therapy intervention. First with augmented forward symmetry, then with 1:1 visual feedback. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Upper limb orthopedic surgery in the past six months
- Known susceptibility to cybersickness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical TherapyRepetitive bimanual task training for upper limb motor function recovery. | Other | Actual - Augmented, Augmented - Actual |
Primary outcome
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)
6 secondary outcomes
Distance traveled of each arm from head
Time frame: Recorded per reach, throughout the session (about 2 hours)
Time to complete task
Time frame: Recorded per reach, throughout the session (about 2 hours)
Movement Smoothness
Time frame: Recorded per arm, per reach, throughout the session (about 2 hours)
Change in Error in Forward Reaching Symmetry Over Time
Time frame: Recorded per reach, throughout the session (about 2 hours)
Compensation Techniques Causing Joint Asymmetry
Time frame: Recorded throughout the session (about 2 hours)
Trunk Compensation
Time frame: Recorded throughout the session (about 2 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Derived from this study: PubMed 31841417Shum 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hendrik FM Van der Loos, PhD, P.Eng principal investigator
The University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy in people with Hemiparesis and Cerebral Palsy, run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Error in Forward Reaching Symmetry (time frame: Recorded per reach, throughout the session (about 2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03766711, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.