18 and older, any sex, with Amputation or Amputation; Traumatic, Leg, Lower. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Daily Step CountPrimary· 1 Month
Prior to each condition, each subject will be fit and aligned on the designated knee by a trained certified prosthetist. An activity monitor (such as the GeneActiv™) will be worn by the subject for each intervention period during the final month of the condition. Similar to prior studies, the investigators will use the activity monitor to track the number of steps the subjects take in each condition per day.
The number of steps per day are averaged over the final month in each condition. A higher value indicates a better outcome.
Group
Value
95% CI
Control (MPK)
5747
± 3212
Power Knee
3162
± 1031
Activities-Specific Balance Confidence Scale (ABC) - Measuring Change From BaselinePrimary· At the end of each 3 month condition
Activities-specific balance confidence (ABC) scale is a structured questionnaire that measures an individual's confidence during ambulatory activities without falling or experiencing a sense of unsteadiness. It consists of 16 questions gauging the individual's confidence while doing activities, from 0 (no confidence) to 4 (complete confidence). Therefore, the total score ranges from 0 to 64, with a higher value indicating a better outcome.
This survey will be given at the end of each study condition (2 conditions, 3 months per condition). This survey will be administered as a part of the mast
Group
Value
95% CI
Control (MPK)
83
± 17
Power Knee
83
± 15
PEQ-Well Being (PEQ-WB) - Measuring Change From BaselinePrimary· At the end of each 3 month condition
The version of the PEQ which will be administered consists of 2 questions in 1 category (well being). For purposes of easier administration, the investigators have adopted the modified 10-point ordinal scale version of the PEQ-WB (scale 1-10, where 1 is the worst and 10 is the best relative to the questions being asked).
This survey will be given at the end of each study condition (2 conditions, 3 months per condition). This survey will be administered as a part of the master questionnaire.
The reported result is the average of the 2 questions in the PEQ-WB. The range of this reported result
Group
Value
95% CI
Control (MPK)
8.3
± 1.6
Power Knee
8.0
± 1.5
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were monitored/collected during each condition. With each condition lasting about 3 months, each participant was monitored for adverse events for about 6 months total. Adverse events were monitored/assessed at least every 2 weeks by phone call, with study staff checking in more frequently if participants reached out with questions. Participants were told to reach out to study staff immediately if adverse events did occur..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The goal of this proposed project is to gather community-based data from the K4-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to maximize the benefit for each patient). The investigators envision that this Level 1 submission will transition into a larger follow-on Level 2 trial that will explore a larger spectrum of patient populations (K2-K4), as well as testing additional Power Knees currently in development that are expected to become commercialized in the near future. The investigators intend to use this Level 2 trial data to guide the implementation of effective prescriptions towards those that can benefit most from a given device and limit prescription to those who would not see benefit in order to ensure the most judicious use of Department of Defense (DoD) and Veteran's Affairs healthcare dollars. The findings will also be shared with the research community to help drive the design of future devices by identifying what features and functions are most beneficial to which patient populations when the devices are used outside of the laboratory. In summary, more community-based data on how powered prosthetic knees compare with MPKs is needed to allow for improved clinical decision making and clinical outcomes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Liberating Technologies, Inc.
Last refreshed: 26 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05267639.