Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID04063592

A Novel Approach to Lower Extremity Residual Limb Revision to Augment Volitional Motor Control, Restore Proprioception and Reverse Limb Atrophy

Led by Brigham and Women's Hospital · Updated on 2025-10-20

26

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

B

Brigham and Women's Hospital

Lead Sponsor

M

Massachusetts Institute of Technology

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating a new surgical method to improve the function and sensation of lower extremity residual limbs in adults who have already had above knee (AK) or below knee (BK) amputations. This approach aims to enhance motor control, restore proprioception (awareness of limb position), reduce phantom limb pain, and regenerate lost muscle mass. The study is designed to develop and test this novel technique and its benefits compared to standard amputation revision methods. The treatment involves a surgical procedure called residual limb revision, which constructs agonist-antagonist myoneural interfaces (AMIs) within the residual limb. This procedure is intended to restore musculotendinous proprioceptive abilities and improve motor and sensory function. Participants will undergo this surgery and serve as their own control to measure changes over time, with a focus on both above and below knee residual limb revisions. The study also aims to establish a new postoperative rehabilitation plan tailored to this surgical approach. Participants will be monitored for up to three years, during which researchers will assess changes in limb shape and muscle volume, motor activation of the AMI muscles, proprioception, sensory perception, general health, and any complications. The study includes various assessments to evaluate the success of the surgery in enhancing limb function and sensation. Participants must be adults aged 18 to 65 who have already had a lower extremity amputation and meet specific health and communication criteria.

CONDITIONS

Brief Title

AMI Construction in Lower Extremity Residual Limbs

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Between the ages of 18-65
  • Has already undergone a standard above knee amputation (AKA) or below knee amputation (BKA) procedure
  • Experiences symptoms such as intractable pain, skin deterioration around the stump, or other stump-related discomfort
  • Has intact inherent wound healing
  • Possesses adequate communication skills
  • Is highly motivated
Not Eligible

You will not qualify if you...

  • Inadequate health to undergo surgery with standard anesthesia (e.g., cardiopulmonary issues)
  • Impaired wound healing
  • Extensive peripheral neuropathies
  • Active smokers
  • History of poor compliance
  • Women who are pregnant or plan to become pregnant before surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgical procedure and acute recovery period

Participants undergo a surgical procedure involving construction of agonist-antagonist myoneural interfaces (AMIs) to modify their residual limbs, followed by immediate post-operative care.

1 surgical visit and immediate post-operative monitoring

Post-operative Follow-up

Duration - Up to 3 years

Participants receive follow-up care to assess motor control, sensory feedback, proprioception, muscle volume changes, and general health over time.

Regular follow-up visits over 3 years

Trial Site Locations

Total: 3 locations

1

Walter Reed National Military Medical Center

Bethesda, Maryland, United States, 20889

Not Yet Recruiting

2

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

3

Massachusetts Institute of Technology

Cambridge, Massachusetts, United States, 02139

Actively Recruiting

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Research Team

M

Matthew J Carty, MD

R

Research Coordinators

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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