PlayGait: A Dynamic Exoskeleton

Study Overview
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Brief Summary
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PlayGait is an investigational dynamic energy storage and return (ESR) lower-limb exoskeleton for young children with cerebral palsy (CP), that stores energy while the child is in the stance phase of walking and returns that energy in terminal stance and early swing phase of walking. PlayGait assists with the passive dynamics of walking through an exotendon (comprised of a spring in series with a cable). The overall objective of this investigational device is to promote correct walking patterns that encourage proper bone alignment, muscle recruitment, and strengthening during walking practice in young children with CP. The study will evaluate children with CP's activity levels in the community with and without PlayGait. The study will consist of three lab visits and two, 7-day periods at home.

Official Title
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PlayGait: A Dynamic Exoskeleton to Improve Community Ambulation

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Device: PlayGait
* Other: Baseline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 3 - 4 years (at time of informed consent) Hemiplegic cerebral palsy If child uses an ankle-foot orthosis (AFO), parent/caregiver is willing to have the child stop wearing their prescribed AFO during data collections (lab sessions and two 7-day periods at home) Ability to walk at least 10 meters without the use of assistive devices or AFOs Ability to walk at least 1 minute without the use of assistive devices or AFOs Stiff knee gait - less than normal knee flexion during swing phase Hip flexion passive range of motion contracture less than 20 degrees Gross Motor Function Classification System (GMFCS) Levels I-II Modified Ashworth Scale (MAS) <=2 for the gastrocnemius soleus, rectus femoris, and hamstrings Family has resources to attend all study sessions (transportation, schedule) Ability to speak and understand in English Exclusion Criteria: Orthopedic surgery in the last year Foster children or wards of the state Use wheelchair or stroller mobility as their primary method of independent mobility Severe visual impairment such that the visual impairment itself functionally limits mobility Phenol or Botox injections to the legs in the last 3 months Uncontrolled seizure disorder, defined as any seizure in the last 3 months that influenced mobility skills and function (seizures which did not affect mobility are acceptable) Lower limb fracture in the last 3 months Planned surgery or changes to movement disorder medication during the study period Inability to understand directions sufficiently to complete the study assessments Cognitive, behavioral, or any other issues that may not allow for effective study participation Unwilling to complete the study protocol

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PlayGait (Exoskeleton)<br>Experimental lower-limb device. | Device: PlayGait<br>* PlayGait is a dynamic energy storing and returning lower-limb exoskeleton.<br>|
| Active Comparator: Baseline<br>Baseline condition without using any prescribed lower-limb orthoses. | Other: Baseline<br>* Baseline condition with no prescribed or intervention lower-limb devices.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cadence | Low, medium, and high activity rate | 7 days with baseline condition; 7 days with PlayGait condition | 
| Shifts in cadence | Shifts from low to medium cadence and shifts from medium to high cadence | 7 days with baseline condition; 7 days with PlayGait condition | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 minute walk test | The distance walked in one minute | 1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait | 
| 10 meter walk test | The time it takes to walk 10 meters | 1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait | 
| Pediatric Balance Scale | Participant completes 14 activity items that measure pediatric balance | 1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait | 
| Average steps per day | Step count per day | Baseline Condition: 7 days in the community without PlayGait (no lower-limb assistive devices); PlayGait condition: 7 days with PlayGait | 
| Time of PlayGait use | Amount of time each day that PlayGait is worn | PlayGait condition: 7 days in the community with PlayGait | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, orthosis, exoskeleton