PlayGait: A Dynamic Exoskeleton

NCT05318690 | Terminated

• 1 other identifier: 0047-01
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

pediatric; orthosis; exoskeleton

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 1 minute walk test

  1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait

• 10 meter walk test

  1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait

• Pediatric Balance Scale

  1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait

• Average steps 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

  PlayGait condition: 7 days in the community with PlayGait

Study Arms (2)

PlayGait (Exoskeleton)

EXPERIMENTAL

Experimental lower-limb device.

Device: PlayGait

Baseline

ACTIVE COMPARATOR

Baseline condition without using any prescribed lower-limb orthoses.

Other: Baseline

Interventions

PlayGait DEVICE

PlayGait is a dynamic energy storing and returning lower-limb exoskeleton.

PlayGait (Exoskeleton)

Baseline OTHER

Baseline condition with no prescribed or intervention lower-limb devices.

Baseline

Eligibility Criteria

• Age: 3 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orthocare Innovations, LLC: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Orthocare Innovations, LLC

Edmonds, Washington, 98020, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

BaseLine dental cement

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jessica Zistatsis, MSME

  Orthocare Innovations

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 8, 2022
• Study Start: March 11, 2022
• Primary Completion: January 3, 2023
• Study Completion: January 3, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

US (1)