Kinematics of Ewing Amputees

NCT06371209 | Enrolling By Invitation

• 1 other identifier: 2022P000619
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lower Extremity Amputation; Trans-Tibial Amputation; Traumatic Lower Extremity Amputation; Agonist-Antagonist Myoneural Interface

Keywords

Amputation; Kinematics; Gait

Outcome Measures

Primary Outcomes (2)

• Duration of co-contraction of the ankle dorsi/plantar-flexor muscles during gait

  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.

  Baseline

• Symmetry of duration of co-contraction of the ankle dorsi/plantar-flexor muscles during gait

  This is estimated by calculating the difference between the duration of co-contraction for the residuum and for the contralateral limb.

  Baseline

Secondary Outcomes (2)

• Symmetry of ankle power generation

  Baseline

• Symmetry of peak knee flexion during stance

  Baseline

Other Outcomes (1)

• Symmetry of step length

  Baseline

Study Arms (2)

Ewing Amputees

Amputees who have previously undergone Agonist-Antagonist Myoneural Interface construction at the trans-tibial level

Procedure: Modified Amputation

Standard Amputees

Amputees who have previously undergone trans-tibial level amputations without the construction of Agonist-Antagonist Myoneural Interfaces

Procedure: Standard Amputation

Interventions

Modified Amputation PROCEDURE

Modified amputation procedure

Ewing Amputees

Standard Amputation PROCEDURE

Standard amputation procedure

Standard Amputees

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Trans-tibial amputees local to or visiting the Massachusetts area

You may qualify if:

• Unilateral lower extremity amputees
• Greater than 12 months post-amputation procedure
• Possession and use of a working prosthesis as determined by subject's ability to wear it for 8 hours daily
• A stable, well-fitting socket as indicated by no prosthetic modifications within the prior 14 days and no plans to modify it within the following 30 days
• Follow-up visit with their prosthetist within the past 3 months
• The ability to walk independently without an assistive device
• The ability to follow directions and communicate pain or discomfort

You may not qualify if:

• Patients beyond the stated age restrictions will be excluded
• Patients who have any underlying neurologic, orthopedic, or cardiopulmonary impairment that affects their gait as assessed by the study clinician.
• Patients with any medical or functional limitations preventing them from ambulating safely and independently without an assistive device.
• Patients will be excluded who do not have a prosthesis

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Mass General Brigham

Boston, Massachusetts, 02129, United States

Location

Related Publications (7)

• Srinivasan SS, Diaz M, Carty M, Herr HM. Towards functional restoration for persons with limb amputation: A dual-stage implementation of regenerative agonist-antagonist myoneural interfaces. Sci Rep. 2019 Feb 13;9(1):1981. doi: 10.1038/s41598-018-38096-z.

  PMID: 30760764 BACKGROUND

• Clites TR, Carty MJ, Ullauri JB, Carney ME, Mooney LM, Duval JF, Srinivasan SS, Herr HM. Proprioception from a neurally controlled lower-extremity prosthesis. Sci Transl Med. 2018 May 30;10(443):eaap8373. doi: 10.1126/scitranslmed.aap8373.

  PMID: 29848665 BACKGROUND

• Srinivasan SS, Carty MJ, Calvaresi PW, Clites TR, Maimon BE, Taylor CR, Zorzos AN, Herr H. On prosthetic control: A regenerative agonist-antagonist myoneural interface. Sci Robot. 2017 May 31;2(6):eaan2971. doi: 10.1126/scirobotics.aan2971.

  PMID: 33157872 BACKGROUND

• Clites TR, Carty MJ, Srinivasan S, Zorzos AN, Herr HM. A murine model of a novel surgical architecture for proprioceptive muscle feedback and its potential application to control of advanced limb prostheses. J Neural Eng. 2017 Jun;14(3):036002. doi: 10.1088/1741-2552/aa614b. Epub 2017 Feb 17.

  PMID: 28211795 BACKGROUND

• Clites TR, Herr HM, Srinivasan SS, Zorzos AN, Carty MJ. The Ewing Amputation: The First Human Implementation of the Agonist-Antagonist Myoneural Interface. Plast Reconstr Surg Glob Open. 2018 Nov 16;6(11):e1997. doi: 10.1097/GOX.0000000000001997. eCollection 2018 Nov.

  PMID: 30881798 BACKGROUND

• Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.

  PMID: 18295618 BACKGROUND

• Brown BJ, Iorio ML, Klement M, Conti Mica MR, El-Amraoui A, O'Halloran P, Attinger CE. Outcomes after 294 transtibial amputations with the posterior myocutaneous flap. Int J Low Extrem Wounds. 2014 Mar;13(1):33-40. doi: 10.1177/1534734614520706. Epub 2014 Feb 6.

  PMID: 24510319 BACKGROUND

Study Officials

• Matthew Carty, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Lower Extremity Transplant Program, Brigham and Women's Hospital

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: April 17, 2024
• Study Start: May 17, 2022
• Primary Completion (Estimated): June 29, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)