PlayGait: A Dynamic Exoskeleton

Not Applicable

Terminated

• Conditions: Cerebral Palsy
• Interventions: Device: PlayGait; Other: Baseline

• Registration Number: NCT05318690
• Lead Sponsor: Orthocare Innovations, LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-11
• Study First Submitted: 2022-03-24
• Study First Submitted QC: 2022-04-01
• Study First Posted: 2022-04-08
• Primary Completion: 2023-01-03
• Study Completion: 2023-01-03
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-06
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PlayGait (Exoskeleton)	PlayGait	Experimental lower-limb device.
Baseline	Baseline	Baseline condition without using any prescribed lower-limb orthoses.

Primary Outcome Measures

Name	Time	Method
Cadence	7 days with baseline condition; 7 days with PlayGait condition	Low, medium, and high activity rate
Shifts in cadence	7 days with baseline condition; 7 days with PlayGait condition	Shifts from low to medium cadence and shifts from medium to high cadence

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Orthocare Innovations, LLC; 🇺🇸 Edmonds, Washington, United States