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Not yet recruiting NCT07360171

Validity Assessment of Sensors for Movement Tracking With Children/Youth With Diverse Neuromotor Abilities

Observational Cerebral Palsy Cerebral Palsy (CP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Validity Assessment of Sensors for Movement Tracking With Children/Youth With Diverse Neuromotor Abilities.
Who it may be relevant to
Registry conditions: Cerebral Palsy, Cerebral Palsy (CP). Basic parameters: 5 years — 24 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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: 1. 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. 2. 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. 3. To explore the extent to which kinematic metrics collected during gameplay (e.g. smoothness of movement, symmetry index) can discriminate different motor abilities. 4. 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.

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.

Interventions

  • Device Validity Assessment of Sensors for Movement Tracking With Children/Youth With Diverse Neuromotor Abilities
    Participants will play active video games by moving their bodies while their movements are tracked by different sensors.

Primary outcome measures

  • Standardized Clinical Assessment: 30 Second Sit To Stand Test [Time frame: Baseline]
  • Standardized Clinical Assessment - Five Times Sit to Stand Test [Time frame: Baseline]
  • Standardized Clinical Assessment: Paediatric Reach Test [Time frame: Baseline]
  • Standardized Clinical Assessment: Single Leg Stance Test [Time frame: Baseline]
  • Standardized Clinical Assessment: Timed Up and Go [Time frame: Baseline]
  • Sensor Movement Tracking Data [Time frame: Baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

Canada · 1 center
  • Holland Bloorview Kids Rehabilitation Hospital — Toronto

Identifiers

NCT: NCT07360171 · 0551

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗