N/A
N=10
Biomechanical Assessment of Gait in Lower-Extremity-Amputees
Prosthesis User
Bottom Line
View on ClinicalTrials.gov: NCT01332123 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: Overall Asymmetry Index — 0.064; 0.352; 0.541; 1.481 unit-less index (0 = perfect symmetry)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Alignment perturbations (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Milwaukee
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Asymmetry Index |
0.064; 0.352; 0.541; 1.481; 0.037; 0.111 | — |
| SECONDARY Heart Rate Change |
55.75 | — |
Summary
This study is investigating the influence of several simulated real life conditions on the symmetry of gait with trans-tibial prostheses
Hypotheses: It is hypothesized that the observable differences in gait pattern between amputees can be detected by a combination of forces and moments that are measured internally in the prosthesis, and electromyography data. It is further hypothesized that changing conditions such as uneven walking surface, prosthetic misalignment or user fatigue are characterized by typical values in the measured data or combinations thereof.
Eligibility Criteria
Inclusion Criteria
- Trans tibial amputation
- Able to walk 30 minutes comfortably
- Modular prosthesis
Exclusion Criteria
- Prosthesis does not provide enough space between socket and foot module to fit the mobile measuring unit
- Physically or mentally unable to perform the required tasks
Data sourced from ClinicalTrials.gov (NCT01332123). 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.