Training Independent Muscle Activation From a Common Source
In this study, the investigators are evaluating a new surgical technique that may allow participants to control their muscles in a new way after their amputation or revision surgery. The investigators are looking for people who have limb amputation or require a revision operation to a previous amputation. Participants must be over 18 and younger than 65, willing to begin participation within two weeks of their surgery, and be willing to travel regularly to Boston.
In this study, participants will have a modified revision procedure on their amputated limb or a modified amputation procedure, followed by a series of follow up visits in clinic and to a gait lab at Harvard. Participants will also use a wearable device on their limb at home to complete daily training tasks and games.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Matthew J Carty, MD
- 전화번호: 617-983-4555
- 이메일: mcarty@bwh.harvard.edu
연구 장소
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02115
- 모병
- Brigham and Women's Hospital
-
연락하다:
- Matthew J Carty, MD
- 전화번호: 617-983-4555
- 이메일: mcarty@bwh.harvard.edu
-
Cambridge, Massachusetts, 미국, 02138
- 아직 모집하지 않음
- Harvard University
-
연락하다:
- Shriya Srinivasan, PhD
- 전화번호: 617-495-3675
- 이메일: shriya_srinivasan@fas.harvard.edu
-
연락하다:
- Jennifer Leestma, PhD
- 이메일: jleestma@seas.harvard.edu
-
수석 연구원:
- Shriya Srinivasan, PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age 18-65
- Fluent in English
- Approved for and scheduled to undergo acute amputation or revision amputation surgery (e.g. above-knee amputation with sciatic nerve ablation) OR sciatic nerve ablation for clinical indications (e.g. persistent pain, symptomatic neuroma, soft tissue breakdown, muscle atrophy, socket-related discomfort).
- Willing and able to initiate participation within 14 days of surgery
- Willing to perform at home studies
- Possess adequate cognitive and communication abilities to describe their sensorimotor recovery during follow-up assessments
- Demonstrate appropriate motivation and reliability to comply with scheduled training and evaluation sessions throughout the postoperative period
- Able to travel to BWH/BWFH and Harvard University for all required visits without lodging support
Exclusion Criteria:
-
• Passive or active metal implants incompatible with EMG
- Pacemakers, deep brain stimulators, or other electronic implantables
- Pregnancy or breastfeeding
- Current seizure disorder or other neurologically limiting conditions
- Cognitive or developmental disorders that limit task comprehension
- Vascular disorders impeding regeneration
- Known impairments in wound healing, including connective tissue disorders or under chronic systemic corticosteroid therapy
- Extensive peripheral neuropathies that may hinder neural regeneration and functional RPNI development
- Active smoker
- Are unable to provide informed consent
- Have a demonstrated history of poor protocol adherence
- Pregnant at the time of screening
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Surgical Intervention - RPNI Construction
Subjects undergoing the proposed operative intervention with associated follow up testing |
amputation or revision procedure in which additional RPNIs (regenerative peripheral nerve interfaces) are created beyond what would be included in a standard care procedure |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Co-Contraction Interference Measure
기간: from operative intervention to 12 months postop
|
Degree of co-contraction interference or crosstalk between RPNIs, modeled by fitting an exponential decay fit to task error over time or repetitions |
from operative intervention to 12 months postop
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Task Performance Measure - Success Rate
기간: from operative intervention to 12 months postop
|
Task success rate, measured by the mean squared error between intended and actual movement paths. |
from operative intervention to 12 months postop
|
|
Task Performance Measure - Speed
기간: immediately post intervention to 12 months postop
|
Task completion speed, measured by the mean squared error between intended and actual movement |
immediately post intervention to 12 months postop
|
|
Task Performance Measure - Participant Controllability
기간: immediately post intervention to 12 months postop
|
Participant controllability over task, measured by the mean squared error between intended and actual movement paths. |
immediately post intervention to 12 months postop
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Matthew J Carty, MD, Brigham and Women's Hospital
- 수석 연구원: Shriya Srinivasan, PhD, Harvard University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025P002165
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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