N/A
N=6
Basic Mobility and Balance Performance of Low Active Transfemoral Prosthesis Users With a Powered Prosthetic Knee
Prosthesis User · Amputation
Bottom Line
View on ClinicalTrials.gov: NCT04799145 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Timed Up and Go Test (TUG Test) — 13.3; 16.8 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Investigational device (Device); Prescribed device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Össur Iceland ehf
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Timed Up and Go Test (TUG Test) |
13.3; 16.8 | — |
| SECONDARY 2 Minute Walk Test |
108.7; 102.1 | — |
Summary
This was a prospective case series design investigation with 6 prosthesis user subjects. Subjects performed the Timed up and go (TUG) test and the two minute walk test (2MWT) along with some activities of daily living (ADL), on their prescribed knee as well as the investigational device at two separate visits. Performance was compared and statistically analyzed.
Eligibility Criteria
Inclusion Criteria
- 50Kg< body weight < 116Kg
- Cognitive ability to understand all instructions and questionnaires in the study;
- K1-K2 unilateral transfemoral amputees
- Allows for 37mm knee center height to dome of pyramid alignment
- Age ≥ 18 years
- Willing and able to participate in the study and follow the protocol
- Comfortable and stable socket fit (5 or over on the SFCS)
Exclusion Criteria
- Users with cognitive impairment
- Users aged <18y
- Bilateral amputees
- Users with stump pain affecting their functional mobility
- Users with socket problems
- Users with co-morbidities in the contra-lateral limb, which significantly affect their functional mobility
Data sourced from ClinicalTrials.gov (NCT04799145). 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.