PlayGait: A Dynamic Exoskeleton

PlayGait: A Dynamic Exoskeleton to Improve Community Ambulation

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.

Study Overview

• Status: Terminated
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: PlayGait; Other: Baseline

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Boone, PhD; Phone Number: 1004 425-771-0797; Email: dboone@orthocareinnovations.com
• Study Contact Backup: Name: Jessica Zistatsis, MSME; Phone Number: 1015 425-771-0797; Email: jzistatsis@orthocareinnovations.com

Study Locations

• United States
  • Washington
    • Edmonds, Washington, United States, 98020
      • Orthocare Innovations, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 4 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Orthocare Innovations, LLC
• Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research
• Investigators: Principal Investigator: Jessica Zistatsis, MSME, Orthocare Innovations

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2022
• Primary Completion (Actual): January 3, 2023
• Study Completion (Actual): January 3, 2023

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: pediatric; exoskeleton; orthosis
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 0047-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No