N/A
N=10
Intent Recognition for Prosthesis Control
Amputation
Bottom Line
View on ClinicalTrials.gov: NCT05537792 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Overground Self-selected Walking Speed — 0.695 Meters per second
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Robotic Knee/Ankle Prosthesis (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Georgia Institute of Technology
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overground Self-selected Walking Speed |
0.695 | — |
| SECONDARY Overground Walking Speed Mean Absolute Error (MAE) |
0.142 | — |
| SECONDARY Treadmill Walking Speed Mean Absolute Error (MAE) |
0.158; 0.155; 0.139; 0.163; 0.138 | 0.579 |
Summary
This work will focus on new algorithms for powered prostheses and testing these in human subject tests. Individuals with above knee amputation will walk with a robotic prosthesis and ambulate over terrain that simulates community ambulation. The investigators will compare the performance of the advanced algorithm with the robotic system that does not use an advanced algorithm.
Eligibility Criteria
Inclusion Criteria
- A unilateral amputation of the lower limb
- Aged between 18 to 75 years, inclusive
- K3 or K4 level ambulators who can perform all locomotor tasks of interest (based on assessment of the physiatrist and/or prosthetist)
- If a prosthesis is used, the participant must use a prosthetic knee and foot in their clinically prescribed prosthesis.
Exclusion Criteria
- Individuals with history of neurological injury, gait pathology, or cardiovascular condition that would limit ability to ambulate for multiple hours
- Individuals who are currently pregnant (based on patient self-report) due to slight risk of falling during experiments
Data sourced from ClinicalTrials.gov (NCT05537792). 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.