- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07360171
Validity Assessment of Sensors for Movement Tracking With Children/Youth With Diverse Neuromotor Abilities (MOCAP)
The overall goal of this study is to establish the clinical utility and accuracy of markerless motion captures systems for tracking therapy exercises and movement during game play. Specific aims are:
- To evaluate the accuracy of the kinematic metrics tracked by marker-less motion capture systems by comparing them to the gold standard marker-based Motion Analysis system.
- To assess agreement between exercise repetition counts and clinical assessment scores determined from data collected by the markerless motion capture systems compared to the gold standard marker-based Motion Analysis system and a trained clinician.
- To explore the extent to which kinematic metrics collected during gameplay (e.g. smoothness of movement, symmetry index) can discriminate different motor abilities.
- To understand children's perspectives on motion capture video games in the context of rehabilitation.
Participants will:
Perform active range of motion of each joint (3 repetitions, outside of the game environment) and rehabilitative movements within games developed at Holland Bloorview that target anatomical movements (e.g. shoulder abduction/adduction, shoulder flexion/extension, elbow flexion/extension, lateral trunk lean, hip flexion/extension, knee flexion/extension, trunk flexion/extension)
Play each mini game until 10 repetitions are made regarding the game objective or 2-minutes of game play is reached.
Study Overview
Status
Conditions
Detailed Description
Problems in prenatal brain development or brain injury in infancy can cause cerebral palsy (CP), a non-progressive disorder associated with impaired movement, posture, and balance. CP is the most common motor disability in children affecting two to three children for every 1000 births.
Although CP is a permanent disability, occupational and physical therapy can be implemented to help improve motor function or manage the symptoms over time. However, access to these therapies can be limited by financial, time, and geographical constraints. This motivates interest in home-based rehabilitation programs. Several studies have evaluated the possibility of active video games (AVGs) to complement conventional in-person rehabilitation interventions and boost motivation in children. The user interacts with the environment within the AVG via different motion-tracking interfaces ranging in complexity from inertial measurement units (i.e. Wii control stick) to 3D depth sensors (i.e. Microsoft Kinect). From a meta-analysis conducted by Ren et al., AVGs have been found to enhance gross motor function for children with CP.
Given the individual rehabilitation goals and abilities of each child, AVGs are most effective when they can be calibrated to target specific body segments for motor skill development. Ideally, AVGs would adapt to the child's physical performance in the same way that a therapist observes a patient's progress and adjusts the intensity and frequency of the exercise. Data collected from technological systems, such as an optoelectronic motion tracking system, has the potential to follow changes in movement abilities to support progress tracking. Gold standard optoelectronic motion capture (e.g., Vicon, Motion Analysis) are too expensive for the home, but there are low-cost, commercial products that are practical for home use (e.g., Microsoft Kinect, Orbbec Persee). While the movement-tracking capabilities of these devices are sufficient to support game play, it is not known how accurately they track movements (i) during game play and (ii) for children with diverse motor skills and patterns. This information is pertinent to validate the use of low-cost optoelectronic, motion-tracking to (i) provide high quality feedback and support practice of therapy exercises (e.g. to what extent can these systems recognize and provide feedback on exercises in the same way that a therapist would?) and (2) track changes in motor performance (i.e. to what extent can these systems be used to accurately quantify and track changes in motor skills?)
To increase accessibility for a larger population of children with CP, a series of interactive video games have been created at the Possibility Engineering and Research Lab (PEARL), which tracks rehabilitation exercises and integrates these into gameplay. The video games, Bootle Blast (BB) and Bootle Boot Camp (BC), utilize a 3D depth sensor, the Orbbec Persee+. Bootle Blast has been successfully piloted by 4 children with CP over 12 weeks in their homes and used in clinics at Holland Bloorview Kids Rehabilitation Hospital since 2017. To date, body tracking has been used primarily to support children's interactions in the games. Its accuracy for tracking therapy exercises, potential to deliver high quality feedback, and validity for quantifying qualities of movement (e.g., reach envelope, smoothness of movement, movement trajectory) has yet to be established.
The overall goal of this study is to establish the clinical utility and accuracy of markerless motion captures systems (e.g. the Orbbec Persee+/Astra 2, Apple LiDAR, 2D cameras + body tracking software) for tracking therapy exercises and movement during game play.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Selvi Sert, MEng
- Phone Number: 3109 416-425-6220
- Email: ssert@hollandbloorview.ca
Study Contact Backup
- Name: Alexander Hodge, BSc
- Phone Number: 3245 416-425-6220
- Email: ahodge@hollandbloorview.ca
Study Locations
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Ontario
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Toronto, Ontario, Canada, M4G 1R8
- Holland Bloorview Kids Rehabilitation Hospital
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Contact:
- Selvi Sert, MEng
- Phone Number: 3109 416-425-6220
- Email: ssert@hollandbloorview.ca
-
Contact:
- Alexander Hodge, BSc
- Phone Number: 3245 416-425-6220
- Email: ahodge@hollandbloorview.ca
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Principal Investigator:
- Elaine Biddiss, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged 5 to 24 years
- Sufficient motor skills to successfully play the game (i.e., able to lift hand above shoulder)
- Able to see and interact with the monitor - minimal visual or auditory impairments
- Willing to wear reflective stickers on skin and on tight fitting clothing
- Willing to wear athletic tape around arms and/or legs to secure loose clothing
- Mobility similar to GMFCS Levels I-III.
Exclusion Criteria:
- Any injury/disability that would make moderate exercise unsafe.
- History of epilepsy aggravated by screen time. For the latter, the child will be eligible to participate if they safely participated in 1 hour of TV/video games per week as reported by the parent.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Primary Arm
Participants' sociodemographic data is collected prior to the active component of study session.
During the active component, participants will play a collection on movement-based video games that target specific rehabilitation movements.
While playing, participants' movements are captured using different technologies including 2D and 3D cameras and marker-based motion capture systems.
The games will be played in a randomized order, and the motion data will be collected for the full duration.
The participants will be able to rest as needed between each mini game.
The overall active game play will be approximately 30 minutes with approximately 10 minutes of walking (3-8 passes on a 5m track for children who are able) and active range of movement measurements.
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Participants will play active video games by moving their bodies while their movements are tracked by different sensors.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Standardized Clinical Assessment: 30 Second Sit To Stand Test
Time Frame: Baseline
|
A measurement that assesses functional lower extremity strength.
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Baseline
|
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Standardized Clinical Assessment - Five Times Sit to Stand Test
Time Frame: Baseline
|
The Five Times Sit to Stand Test measures one aspect of transfer skill.
The test provides a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements.
|
Baseline
|
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Standardized Clinical Assessment: Paediatric Reach Test
Time Frame: Baseline
|
A modified form of the Functional Reach Test (FRT).
The PRT measures side reaching as well as forward reaching in both sitting and standing positions.
|
Baseline
|
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Standardized Clinical Assessment: Single Leg Stance Test
Time Frame: Baseline
|
Used to assess static postural and balance control
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Baseline
|
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Standardized Clinical Assessment: Timed Up and Go
Time Frame: Baseline
|
Assesses mobility, balance, walking ability, and fall risk
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Baseline
|
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Sensor Movement Tracking Data
Time Frame: Baseline
|
Joint positions in X-Y-Z coordinate space.
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Baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Elaine Biddiss, PhD, Holland Bloorview Kids Rehabilitation Hospital, Bloorview Research Institute
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0551
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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