PlayGait: A Dynamic Exoskeleton | NCT05318690

Studies
PlayGait: A Dynamic Exoskeleton

NCT05318690

Sponsor

Orthocare Innovations, LLC

Status

Terminated

Last Update Posted

Oct 10, 2023Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Cerebral Palsy

Interventions

PlayGait
Baseline

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty with recruitment

Expanded Access Info

Start Date

Mar 11, 2022Actual

Primary Completion Date

Jan 3, 2023Actual

Completion Date

Jan 3, 2023Actual

First Submitted Date

Mar 24, 2022

First Submission Date that Met QC Criteria

Apr 1, 2022

First Posted Date

Apr 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2023

Last Update Posted Date

Oct 10, 2023Actual

Name	Class
National Institute on Disability, Independent Living, and Rehabilitation Research	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PlayGait (Exoskeleton)	Experimental	Experimental lower-limb device.	Device: PlayGait
Baseline	Active Comparator	Baseline condition without using any prescribed lower-limb orthoses.	Other: Baseline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PlayGait	Device	PlayGait is a dynamic energy storing and returning lower-limb exoskeleton.	PlayGait (Exoskeleton)

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

4 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases