Cerebral PalsyNCT05318690
PlayGait: A Dynamic Exoskeleton
A study testing PlayGait and Baseline in people with Cerebral Palsy, run by Orthocare Innovations, LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 4 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- PlayGait and Baseline
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2022to 3 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Orthocare Innovations, LLC
Edmonds, Washington, 98020
About this study
Official title: 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.
- Conditions
- Cerebral Palsy
- Being tested
- PlayGait, Baseline
- Keywords
- pediatric, orthosis, exoskeleton
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlayGaitDevice
PlayGait is a dynamic energy storing and returning lower-limb exoskeleton.
BaselineOther
Baseline condition with no prescribed or intervention lower-limb devices.
| Study group | Role | What they receive |
|---|---|---|
| PlayGait (Exoskeleton) | Experimental | Experimental lower-limb device. Receives: Device: PlayGait |
| Baseline | Active comparator | Baseline condition without using any prescribed lower-limb orthoses. Receives: Other: Baseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cadence
Low, medium, and high activity rate
Measured: 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
Measured: 7 days with baseline condition; 7 days with PlayGait condition
Secondary outcomes (5)
1 minute walk test
The distance walked in one minute
Measured: 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
Measured: 1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait
Pediatric Balance Scale
Participant completes 14 activity items that measure pediatric balance
Measured: 1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait
Average steps per day
Step count per day
Measured: Baseline Condition: 7 days in the community without PlayGait (no lower-limb assistive devices); PlayGait condition: 7 days with PlayGait
Time of PlayGait use
Amount of time each day that PlayGait is worn
Measured: PlayGait condition: 7 days in the community with PlayGait
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start11 Mar 2022
- Primary completion3 Jan 2023
- Study completion3 Jan 2023
Why it stopped: Difficulty with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthocare Innovations, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Sponsor
- Investigators
- Jessica Zistatsis, MSME, Principal investigator, Orthocare Innovations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318690
- Sponsor's protocol ID
- 0047-01
- Status last verified
- Oct 2023
- First submitted
- 24 Mar 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PlayGait: A Dynamic Exoskeleton to Improve Community Ambulation
- ClinicalTrials.gov ID
- NCT05318690
- Acronym / sponsor ID
- 0047-01
- Conditions
- Cerebral Palsy
- Keywords
- pediatric, orthosis, exoskeleton
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Orthocare Innovations, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PlayGait (Exoskeleton) | Experimental | Device: PlayGaitExperimental lower-limb device. |
| Baseline | Active comparator | Other: BaselineBaseline condition without using any prescribed lower-limb orthoses. |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlayGaitPlayGait is a dynamic energy storing and returning lower-limb exoskeleton. | Device | PlayGait (Exoskeleton) |
| BaselineBaseline condition with no prescribed or intervention lower-limb devices. | Other | Baseline |
Primary outcome
Cadence
Time frame: 7 days with baseline condition; 7 days with PlayGait condition
Low, medium, and high activity rate
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
5 secondary outcomes
1 minute walk test
Time frame: 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
Pediatric Balance Scale
Time frame: 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
Time of PlayGait use
Time frame: PlayGait condition: 7 days in the community with PlayGait
Results and safety
The study was stopped early (reason given: Difficulty with recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Zistatsis, MSME principal investigator
Orthocare Innovations
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PlayGait and Baseline in people with Cerebral Palsy, run by Orthocare Innovations, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty with recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cadence (time frame: 7 days with baseline condition; 7 days with PlayGait condition). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.