N/A
N=3
Assist-Knee: Energy-Harvesting Knee Prosthesis
Transfemoral Amputation · Artificial Limbs
Bottom Line
View on ClinicalTrials.gov: NCT04023045 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Time to Complete Sit-to-Stand — 1.6; 2.2; 1.4 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Assist-Knee (Device); Habitual Prosthesis (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Orthocare Innovations, LLC
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Complete Sit-to-Stand |
3.4; 2.7; 6.4; 3.8; 2.4; 2.9 | — |
| PRIMARY Time to Complete Sit-to-Stand |
3.4; 2.7; 6.4; 3.8; 2.4; 2.9 | — |
| SECONDARY Timed Up and Go (TUG) Test |
12.3; 12.8; 25.0; 22.0; 20.8; 18.8 | — |
| SECONDARY Timed Up and Go (TUG) Test |
12.3; 12.8; 25.0; 22.0; 20.8; 18.8 | — |
| SECONDARY Time to Complete Stand-to-Sit |
4.4; 3.3; 4.9; 4.5; 2.5; 2.7 | — |
| SECONDARY Time to Complete Stand-to-Sit |
4.4; 3.3; 4.9; 4.5; 2.5; 2.7 | — |
| SECONDARY Percentage of Body Weight on Contralateral Limb at 65 Degrees Knee Flexion |
67.7; 82.0; 48.0; 83.5; 23.5; 27.0 | — |
| SECONDARY Percentage of Body Weight on Contralateral Limb at 65 Degrees Knee Flexion |
67.7; 82.0; 48.0; 83.5; 23.5; 27.0 | — |
Summary
The purpose of this research is to validate the Assist-Knee design and function by collecting pilot data during the stand-to-sit-to-stand transition in transfemoral prosthesis users when using the Assist-Knee to harvest energy and return energy .
Eligibility Criteria
Inclusion Criteria
- Unilateral transfemoral limb loss
- At least one year post-amputation and currently successfully using a prosthesis
- Uses modular endoskeletal prosthetic components
- Has bilateral normal range of motion
- Ability to perform the following activities:
- Walking ability or ability to take steps over 10 meters
- Upright standing stability
- Stand-to-sit stability (i.e. go from a standing position to a seated position independently)
- Sit-to-stand stability (i.e. rise from a seated position independently)
- Ability to communicate individual perceptions in the English language
- Ability to provide informed consent
Exclusion Criteria
- Confounding injury or musculoskeletal problem
- Pregnancy
- Lower limb peripheral neuropathy
- Symptomatic cardiovascular disease or chronic obstructive pulmonary disease
- Not able to read and understand English
- Use of assistive devices for sit-to-stand and stand-to-sit (e.g. canes, walkers)
Data sourced from ClinicalTrials.gov (NCT04023045). 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.