PlayGait: A Dynamic Exoskeleton

NCT ID: NCT05318690

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-11
• Study Completion Date: 2023-01-03

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

PlayGait (Exoskeleton)

Experimental lower-limb device.

Group Type: EXPERIMENTAL

PlayGait

Intervention Type: DEVICE

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

Baseline

Baseline condition without using any prescribed lower-limb orthoses.

Group Type: ACTIVE_COMPARATOR

Baseline

Intervention Type: OTHER

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

Interventions

PlayGait

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

Intervention Type: DEVICE

Baseline

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Disability, Independent Living, and Rehabilitation Research

FED

Sponsor Role: collaborator

Orthocare Innovations, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Zistatsis, MSME

Role: PRINCIPAL_INVESTIGATOR

Orthocare Innovations

Locations

Orthocare Innovations, LLC

Edmonds, Washington, United States

Countries

United States

Other Identifiers

0047-01

Identifier Type: -

Identifier Source: org_study_id