Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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