Clinical trial NCT04119063: Evaluating Wearable Robotic Assistance on Gait
Official title: Evaluating Wearable Robotic Assistance on Gait Mechanics and Energetics in Individuals With Neurological Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cerebral Palsy
Lead sponsor: Northern Arizona University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-10-08
Enrollment: 6
Sex: ALL
Minimum age (years): 5
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility assessment of powered orthosis assistance and resistance during walking. All participants received high frequency gait training followed by a washout period then low frequency gait training.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The overarching goal of this study is to improve mobility in individuals with movement disorders through advances in wearable assistance (i.e. powered orthoses).

Detailed description: Individuals with cerebral palsy completed high frequency over-ground gait training (4x/week for 1 week) with ankle exoskeleton assistance, and then, after a 1 year washout period, the same participants will complete low frequency over-ground gait training (2x/week for 2 weeks).

Eligibility criteria: Inclusion Criteria:

* Age between 5 and 35 years old, inclusive.
* Either a healthy volunteer or a diagnosis of a neurologically-based walking disorder due to stroke, spinal cord injury, Parkinson's disease, or cerebral palsy.
* Must be able to understand and follow simple directions based on parent report and clinical observation during the history and physical examination.
* Able to provide verbal assent, if appropriate. If the participant is non-verbal, parental interpretation of gesticulation for assent will be used.
* The ability to read and understand English.
* Able to walk at least 30 feet with or without a walking aid (GMFCS Level I-III for individuals with cerebral palsy)

Exclusion Criteria:

• Any neurological, musculoskeletal or cardiorespiratory injury, health condition ( including pregnancy), or diagnosis other than stroke, spinal cord injury, Parkinson's disease or cerebral palsy that would affect the ability to walk as directed for short periods of time.

Primary outcomes:
measure: The Metabolic Energy Required to Walk
timeFrame: Measured at the pre (day 1) and post (day 4) gait training assessments
measure: Change in Walking Speed
timeFrame: Measured at the pre (day 1) and post (day 4) gait training assessments
Secondary outcomes:
measure: Change in Stride Length
timeFrame: Measured at the pre (day 1) and post (day 4) gait training assessments
measure: Change in Cadence
timeFrame: Measured at the pre (day 1) and post (day 4) gait training assessments
measure: Change in Muscle Activity Variance Ratio
timeFrame: Measured at the pre (day 1) and post (day 4) gait training assessments
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: Northern Arizona University
state: Arizona
Study officials:
References:
citation: Orekhov G, Fang Y, Cuddeback CF, Lerner ZF. Usability and performance validation of an ultra-lightweight and versatile untethered robotic ankle exoskeleton. J Neuroeng Rehabil. 2021 Nov 10;18(1):163. doi: 10.1186/s12984-021-00954-9.