Kinematics of Ewing Amputees
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Brigham and Women's Hospital
- Study ID
- NCT06371209
- Status
- Enrolling By Invitation
Conditions
- Agonist-Antagonist Myoneural Interface
- Lower Extremity Amputation
- Trans-Tibial Amputation
- Traumatic Lower Extremity Amputation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Modified Amputation — PROCEDUREModified amputation procedure
- Standard Amputation — PROCEDUREStandard amputation procedure
Study Details
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.
Key Dates
- Start date
- May 17, 2022
- Status verified
- Feb 2025
- Primary completion
- Jun 29, 2026
- Completion
- Jul 1, 2026
Study Design
- Enrollment
- 32 participants (estimated)
Arms
- Arm: Ewing AmputeesAmputees who have previously undergone Agonist-Antagonist Myoneural Interface construction at the trans-tibial level
- Arm: Standard AmputeesAmputees who have previously undergone trans-tibial level amputations without the construction of Agonist-Antagonist Myoneural Interfaces
Primary Outcome Measure
Duration of co-contraction of the ankle dorsi/plantar-flexor muscles during gait [ Time Frame: Baseline ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mass General Brigham | Boston | Massachusetts | 02129 | - |
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