PlayGait: A Dynamic Exoskeleton

October 6, 2023 updated by: Orthocare Innovations, LLC

PlayGait: A Dynamic Exoskeleton to Improve Community Ambulation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Washington
      • Edmonds, Washington, United States, 98020
        • Orthocare Innovations, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 4 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PlayGait (Exoskeleton)
Experimental lower-limb device.
Device: PlayGait
PlayGait is a dynamic energy storing and returning lower-limb exoskeleton.
Active Comparator: Baseline
Baseline condition without using any prescribed lower-limb orthoses.
Other: Baseline
Baseline condition with no prescribed or intervention lower-limb devices.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cadence
Time Frame: 7 days with baseline condition; 7 days with PlayGait condition
Low, medium, and high activity rate
7 days with baseline condition; 7 days with PlayGait condition
Shifts in cadence
Time Frame: 7 days with baseline condition; 7 days with PlayGait condition
Shifts from low to medium cadence and shifts from medium to high cadence
7 days with baseline condition; 7 days with PlayGait condition

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
1 minute walk test
Time Frame: 1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait
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
Time Frame: 1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait
The time it takes to walk 10 meters
1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait
Pediatric Balance Scale
Time Frame: 1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait
Participant completes 14 activity items that measure pediatric balance
1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait
Average steps per day
Time Frame: Baseline Condition: 7 days in the community without PlayGait (no lower-limb assistive devices); PlayGait condition: 7 days with PlayGait
Step count 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
Time Frame: PlayGait condition: 7 days in the community with PlayGait
Amount of time each day that PlayGait is worn
PlayGait condition: 7 days in the community with PlayGait

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Orthocare Innovations, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Disability, Independent Living, and Rehabilitation Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jessica Zistatsis, MSME, Orthocare Innovations

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 3, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0047-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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