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NCT06433648 · ClinicalTrials.gov registry record · NA
Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait
A NA study of Amputation and Amputation, Traumatic, sponsored by Shirley Ryan AbilityLab.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06433648: Recruiting NA study of Amputation and Amputation, Traumatic, sponsored by Shirley Ryan AbilityLab.
NCT06433648 is a NA study of Amputation and Amputation, Traumatic that is actively recruiting participants, run by Shirley Ryan AbilityLab. The registered enrollment target is 20 participants, below the 133-participant average among 65 other Amputation trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06433648, a NA study of Amputation and Amputation, Traumatic, is actively recruiting participants, sponsored by Shirley Ryan AbilityLab.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to understand how providing power at the knee or ankle individually, or providing power at both the knee and ankle, impacts ambulation for K2 level transfemoral amputees. Aim 1: measure functional performance of K2 level ambulators when using a commercially available passive microprocessor knee prosthesis (Ottobock Cleg/Ottobock foot) or a powered knee and ankle prosthesis (SRALab Hybrid Knee and SRAlab Polycentric Powered Ankle. Aim 2: Participants will be evaluated on the contribution of adding power at the knee only or the ankle only. Aim 3: The investigators will evaluate the functional performance after intensive clinical gait training on the powered knee and ankle prosthesis (SRALab Hybrid Knee and SRALab Polycentric Powered Ankle). Our hypothesis is that providing powered componentry will improve function and that intensive training will magnify those improvements.
Primary Outcome
The AMPRO measures the ambulatory potential of lower limb amputees. It is used to assess functional mobility through a standardized sequence of mobility tests while using a prosthesis. Individual tasks are scored and combined, resulting in a total assessment score out of a possible 47; the minimum score is zero. Higher scores indicate better mobility. The AMPPRO is a reliable performance measure that has been validated for those with lower limb loss; it measures several functional mobility task
Conditions Studied
Interventions
- DEVICE Ottobock CLeg4 + Ottobock foot
- DEVICE SRALAB Hybrid Knee + Polycentric Ankle
- DEVICE SRALAB Hybrid Knee + Passive Ankle
- DEVICE Ottobock CLeg 4 + Polycentric Ankle
Study Locations (1)
Illinois
- Shirley Ryan AbilityLab - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-05-01 |
| Est. Completion | 2029-06-30 |
| Phase | NA |
What NCT06433648 shows while recruiting
NCT06433648 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 65 other Amputation trials with a reported enrollment target (85% lower).
The record links to 4 conditions, with Amputation appearing as the primary indexed condition, and to 4 interventions - of which Ottobock CLeg4 + Ottobock foot is the first listed.
NCT06433648 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT06433648 about?
NCT06433648 is a clinical study titled "Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait". The goal of this study is to understand how providing power at the knee or ankle individually, or providing power at both the knee and ankle, impacts ambulation for K2 level transfemoral amputees. Aim 1: measure functional performance of K2 level ambulators when using a commercially available passi...
What is the current status of trial NCT06433648?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2023-05-01. Estimated completion is 2029-06-30.
What conditions does trial NCT06433648 study?
This clinical trial studies the following conditions: Amputation, Amputation, Traumatic, Amputation; Traumatic, Limb, Amputation of Knee.
What interventions are being tested in trial NCT06433648?
The interventions under investigation include: Ottobock CLeg4 + Ottobock foot (DEVICE), SRALAB Hybrid Knee + Polycentric Ankle (DEVICE), SRALAB Hybrid Knee + Passive Ankle (DEVICE), Ottobock CLeg 4 + Polycentric Ankle (DEVICE).
Who is sponsoring clinical trial NCT06433648?
This trial is sponsored by Shirley Ryan AbilityLab, which has 138 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06433648 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06433648's enrollment target sits among peer trials
20 33rd of 65 higher than 25 of 65 other Amputation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amputation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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