Last reviewed · How we verify
Investigation on a New Power Knee Firmware Update on Gait and Daily Life Activities for Transfemoral Amputees
NA trial testing Power Knee Firmware Update in Amputation in 6 participants. Terminated before completion.
| Lead sponsor | Össur Iceland ehf |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | other |
| Enrollment | 6 |
| Start date | 2 December 2024 |
| Primary completion | 6 December 2024 |
| Estimated completion | 6 December 2024 |
| Sites | 1 location across United States |
Össur Iceland ehf
18 and older, any sex, with Amputation or Transfemoral Amputation. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Each participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware when performing sit to stand activity
| Group | Value | 95% CI |
|---|---|---|
| Combined Crossover Evaluation Group | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Combined Crossover Evaluation Group | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Combined Crossover Evaluation Group | 3 |
Each participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware when performing stand to sit activity
| Group | Value | 95% CI |
|---|---|---|
| Combined Crossover Evaluation Group | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Combined Crossover Evaluation Group | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Combined Crossover Evaluation Group | 1 |
Each participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware when performing level ground walking.
| Group | Value | 95% CI |
|---|---|---|
| Combined Crossover Evaluation Group | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Combined Crossover Evaluation Group | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Combined Crossover Evaluation Group | 2 |
The 2-Minute Walk Test is a clinical assessment used to measure an individual's walking endurance and functional capacity. During the test, the participant is instructed to walk for 2 minutes at their comfortable pace along a marked course. The total distance walked within the 2-minute period is recorded (in meters).
| Group | Value | 95% CI |
|---|---|---|
| Current Marketed Firmware | 173.5 | ± 19.1 |
| New Investigational Firmware | 179.5 | ± 0.7 |
The 10-Meter Walk Test is a commonly used clinical assessment to measure an individual's walking speed over a short distance. During the test, the participant is asked to walk a distance of 10 meters at their fastest possible pace. The time taken to walk the 10 meters is recorded.
| Group | Value | 95% CI |
|---|---|---|
| Current Marketed Firmware | 6.91 | ± 1.14 |
| New Investigational Firmware | 6.61 | ± 1.66 |
The goal of this interventional study is to investigate a new firmware in development for Power Knee on gait and daily life activities in unilateral transfemoral amputees. The main question it aims to answer is: What are the effects of a new firmware on sit-to-stand, level walking and stair ascent ? Researchers will compare both a new and the current marketed firmware to see if there is any changes in performance. Participants will be asked to perform some activities of daily living and some functional tests.
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
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/NCT06620861.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing