Clinical trial NCT05318690: PlayGait: A Dynamic Exoskeleton
Official title: PlayGait: A Dynamic Exoskeleton to Improve Community Ambulation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cerebral Palsy
Keywords: pediatric
orthosis
exoskeleton
Lead sponsor: Orthocare Innovations, LLC
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2022-04-08
Enrollment: 1
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

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.


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

Primary outcomes:
measure: Cadence
timeFrame: 7 days with baseline condition; 7 days with PlayGait condition
measure: Shifts in cadence
timeFrame: 7 days with baseline condition; 7 days with PlayGait condition
Secondary outcomes:
measure: 1 minute walk test
timeFrame: 1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait
measure: 10 meter walk test
timeFrame: 1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait
measure: Pediatric Balance Scale
timeFrame: 1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait
measure: Average steps per day
timeFrame: Baseline Condition: 7 days in the community without PlayGait (no lower-limb assistive devices); PlayGait condition: 7 days with PlayGait
measure: Time of PlayGait use
timeFrame: PlayGait condition: 7 days in the community with PlayGait
Other outcomes:
Locations:
city: Edmonds
country: United States
facility: Orthocare Innovations, LLC
state: Washington
Study officials:
affiliation: Orthocare Innovations
name: Jessica Zistatsis, MSME
role: PRINCIPAL_INVESTIGATOR
References: