N/A
N=10
Powered Hip Exoskeleton Assistance Study
Lower Limb Injury
Bottom Line
View on ClinicalTrials.gov: NCT03924752 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Self-Selected Walking Speed Using Hip Exoskeleton Assistance Across Different Locomotion Modes — 1.14; 1.26; 1.26; 0.61 meters per second — p=0.9547
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Powered hip exoskeleton (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Georgia Institute of Technology
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-Selected Walking Speed Using Hip Exoskeleton Assistance Across Different Locomotion Modes |
1.14; 1.26; 1.26; 0.61; 0.71 | 0.9547 |
Summary
The increased metabolic and biomechanical demands of ambulation limit community mobility in persons with lower limb disability due to neurological damage. There is a critical need for improving the locomotion capabilities of individuals who have walking impairments due to disease to increase their community mobility, independence, and health. Robotic exoskeletons have the potential to assist these individuals by increasing community mobility to improve quality of life. While these devices have incredible potential, current technology does not support dynamic movements common with locomotion such as transitioning between different gaits and supporting a wide variety of walking speeds. One significant challenge in achieving community ambulation with exoskeletons is providing an adaptive control system to accomplish a wide variety of locomotor tasks. Many exoskeletons today are developed without a detailed understanding of the effect of the device on the human musculoskeletal system. This research is interested in studying the question of how the control system affects human biomechanics including kinematic, kinetics and muscle activation patterns. By optimizing exoskeleton controllers based on human biomechanics and adapting control based on task, the biggest benefit to patient populations will be achieved to help advance the state-of-the-art with assistive hip exoskeletons.
Eligibility Criteria
Inclusion Criteria
- Between 18-85 years of age
- Subjects should be capable of walking, ascending/descending stairs and ramps with full capability in lower extremity passive range of motion (knee flexion contracture of >10 degrees, knee flexion ROM 15 degrees).
- Subjects must be able to walk for at least 5 minutes and willing and able to participate over a 1-6 hours experiment with breaks and rest enforced regularly and as needed.
- Subjects must be able to transfer (sit-to-stand and stand-to-sit) with no external support (arm rests OK) and to ambulate over small slopes (3 degrees) and a few steps (6 steps).
Exclusion Criteria
- History of neurological injury, gait pathology, or cardiovascular condition that would limit your ability to ambulate for multiple hours.
Data sourced from ClinicalTrials.gov (NCT03924752). 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.