PlayGait: A Dynamic Exoskeleton

Cerebral Palsy Clinical Trial

Official title:

PlayGait: A Dynamic Exoskeleton to Improve Community Ambulation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05318690
• Other study ID #: 0047-01
• Status: Terminated
• Phase: N/A
• Start date: March 11, 2022
• Est. completion date: January 3, 2023

Study information

• Verified date: October 2023
• Source: Orthocare Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 3, 2023
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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

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

Locations

Country	Name	City	State
United States	Orthocare Innovations, LLC	Edmonds	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Orthocare Innovations, LLC	National Institute on Disability, Independent Living, and Rehabilitation Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cadence	Low, medium, and high activity rate	7 days with baseline condition; 7 days with PlayGait condition
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time of PlayGait use	Amount of time each day that PlayGait is worn	PlayGait condition: 7 days in the community with PlayGait