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PlayGait: A Dynamic Exoskeleton

Primary Purpose

Cerebral Palsy

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PlayGait
Baseline
Sponsored by
Orthocare Innovations, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Cerebral Palsy focused on measuring pediatric, orthosis, exoskeleton

Eligibility Criteria

3 Years - 4 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orthocare Innovations, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PlayGait (Exoskeleton)

Baseline

Arm Description

Experimental lower-limb device.

Baseline condition without using any prescribed lower-limb orthoses.

Outcomes

Primary Outcome Measures

Cadence
Low, medium, and high activity rate
Shifts in cadence
Shifts from low to medium cadence and shifts from medium to high cadence

Secondary Outcome Measures

1 minute walk test
The distance walked in one minute
10 meter walk test
The time it takes to walk 10 meters
Pediatric Balance Scale
Participant completes 14 activity items that measure pediatric balance
Average steps per day
Step count per day
Time of PlayGait use
Amount of time each day that PlayGait is worn

Full Information

First Posted
March 24, 2022
Last Updated
October 6, 2023
Sponsor
Orthocare Innovations, LLC
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
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1. Study Identification

Unique Protocol Identification Number
NCT05318690
Brief Title
PlayGait: A Dynamic Exoskeleton
Official Title
PlayGait: A Dynamic Exoskeleton to Improve Community Ambulation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Difficulty with recruitment
Study Start Date
March 11, 2022 (Actual)
Primary Completion Date
January 3, 2023 (Actual)
Study Completion Date
January 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orthocare Innovations, LLC
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
pediatric, orthosis, exoskeleton

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PlayGait (Exoskeleton)
Arm Type
Experimental
Arm Description
Experimental lower-limb device.
Arm Title
Baseline
Arm Type
Active Comparator
Arm Description
Baseline condition without using any prescribed lower-limb orthoses.
Intervention Type
Device
Intervention Name(s)
PlayGait
Intervention Description
PlayGait is a dynamic energy storing and returning lower-limb exoskeleton.
Intervention Type
Other
Intervention Name(s)
Baseline
Intervention Description
Baseline condition with no prescribed or intervention lower-limb devices.
Primary Outcome Measure Information:
Title
Cadence
Description
Low, medium, and high activity rate
Time Frame
7 days with baseline condition; 7 days with PlayGait condition
Title
Shifts in cadence
Description
Shifts from low to medium cadence and shifts from medium to high cadence
Time Frame
7 days with baseline condition; 7 days with PlayGait condition
Secondary Outcome Measure Information:
Title
1 minute walk test
Description
The distance walked in one minute
Time Frame
1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait
Title
10 meter walk test
Description
The time it takes to walk 10 meters
Time Frame
1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait
Title
Pediatric Balance Scale
Description
Participant completes 14 activity items that measure pediatric balance
Time Frame
1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait
Title
Average steps per day
Description
Step count per day
Time Frame
Baseline Condition: 7 days in the community without PlayGait (no lower-limb assistive devices); PlayGait condition: 7 days with PlayGait
Title
Time of PlayGait use
Description
Amount of time each day that PlayGait is worn
Time Frame
PlayGait condition: 7 days in the community with PlayGait

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Zistatsis, MSME
Organizational Affiliation
Orthocare Innovations
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthocare Innovations, LLC
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98020
Country
United States

12. IPD Sharing Statement

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PlayGait: A Dynamic Exoskeleton

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