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NCT06371209 · ClinicalTrials.gov registry record
Kinematics of Ewing Amputees
A clinical trial, sponsored by Brigham and Women's Hospital.
- Active
- Registry status
- 32
- Enrollment target
NCT06371209: Active study, sponsored by Brigham and Women's Hospital.
NCT06371209 is a clinical trial that is active but no longer recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 32 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06371209 is active but no longer recruiting, sponsored by Brigham and Women's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- 32 participants
- Enrollment target
Study Summary
The agonist-antagonist myoneural interface (AMI) construct, known as the Ewing amputation at the trans-tibial level, has been shown to create a bi-directional neural communication platform as a means of controlling and interpreting proprioceptive feedback from a prosthetic joint. In AMI constructs, agonist-antagonist muscles are mechanically coupled within the residual limb, and volitional contraction of an agonist passively stretches that muscle's antagonist. The natural neural responses from muscle spindles within both muscles are then interpreted by the central nervous system as sensations of joint position and speed, associated with movement of the prosthesis. The aim of this research protocol is to evaluate the electromyographic and kinematic patterns of participants who have undergone unilateral lower extremity Ewing Amputation in order to determine how similar their residual limb data is when compared to their intact limb data. A secondary aim of this research may include comparison of the Ewing participant cohort's biomechanical patterns to a similar cohort of participants who have undergone standard amputation. The investigators hypothesize that the affected limb of patients with the Ewing procedure will demonstrate a pattern of electromyographic activation of their AMI constructs and kinematic data that recapitulates the pattern seen in their intact limb. The investigators secondarily hypothesize that the kinematic assessment of Ewing Amputation patients will demonstrate patterns that are significantly more physiologic than those witnessed in similar assessments of standard amputees.
Primary Outcome
The percentage of the gait cycle during which both the Tibialis Anterior and the Gastrocnemius muscles are active is estimated for the residuum and the contralateral side.
Interventions
- PROCEDURE Modified Amputation
- PROCEDURE Standard Amputation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2022-05-17 |
| Est. Completion | 2026-12-01 |
What the registry record for NCT06371209 still lists
NCT06371209 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 32 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Modified Amputation is the first listed.
NCT06371209 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06371209 about?
NCT06371209 is a clinical study titled "Kinematics of Ewing Amputees". The agonist-antagonist myoneural interface (AMI) construct, known as the Ewing amputation at the trans-tibial level, has been shown to create a bi-directional neural communication platform as a means of controlling and interpreting proprioceptive feedback from a prosthetic joint. In AMI constructs, ...
What is the current status of trial NCT06371209?
This trial is currently active not recruiting. The enrollment target is 32 participants. The study started on 2022-05-17. Estimated completion is 2026-12-01.
What interventions are being tested in trial NCT06371209?
The interventions under investigation include: Modified Amputation (PROCEDURE), Standard Amputation (PROCEDURE).
Who is sponsoring clinical trial NCT06371209?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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