Early Phase 1
N=6
Evaluating Wearable Robotic Assistance on Gait
Cerebral Palsy
Bottom Line
View on ClinicalTrials.gov: NCT04119063 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: The Metabolic Energy Required to Walk — 2.42; -2.14 % change pre vs post gait training — p=0.204
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- powered orthosis (Device)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- Northern Arizona University
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Metabolic Energy Required to Walk |
2.42; -2.14 | 0.204 |
| PRIMARY Change in Walking Speed |
25.39; 8.09 | 0.049 sig |
| SECONDARY Change in Stride Length |
16.28; 3.87 | 0.039 sig |
| SECONDARY Change in Cadence |
22.47; 4.04 | 0.242 |
| SECONDARY Change in Muscle Activity Variance Ratio |
-47.24; 18.80 | .014 sig |
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).
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.
Data sourced from ClinicalTrials.gov (NCT04119063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.