Status:
TERMINATED
PlayGait: A Dynamic Exoskeleton
Lead Sponsor:
Orthocare Innovations, LLC
Collaborating Sponsors:
National Institute on Disability, Independent Living, and Rehabilitation Research
Conditions:
Cerebral Palsy
Eligibility:
All Genders
3-4 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2023
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT05318690
Start Date
March 11 2022
End Date
January 3 2023
Last Update
October 10 2023
Active Locations (1)
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1
Orthocare Innovations, LLC
Edmonds, Washington, United States, 98020