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 — PROCEDURE
    Modified amputation procedure
  • Standard Amputation — PROCEDURE
    Standard 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 Amputees
    Amputees who have previously undergone Agonist-Antagonist Myoneural Interface construction at the trans-tibial level
  • Arm: Standard Amputees
    Amputees 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)

FacilityCityStateZIPSite coordinators
Mass General BrighamBostonMassachusetts02129-

Find similar trials in Boston, MA

Related Studies