Determining the Effects of Ischemic Conditioning and Neuromuscular Electrical Stimulation on Overall Function After Lower Limb Amputation
2026년 6월 17일 업데이트: University of Illinois at Chicago
Improving Muscle Strength and Function After Lower Limb Amputation
The goal of this clinical trial is to learn if ischemic conditioning and neuromuscular electrical stimulation improves muscle strength and walking behavior in those with limb loss. The main questions this trial aims to answer are:
Does neuromuscular electrical stimulation improve muscle strength and gait behavior in people who have a leg amputation?
Does neuromuscular electrical stimulation boost the effects of ischemic conditioning on muscle strength and gait behavior in people who have a leg amputation?
Researchers will compare the effects of neuromuscular electrical stimulation to ischemic conditioning to see if there are any significant differences between the impacts of each intervention. Also, researchers will use both interventions together to see if the interventions can boost each other's positive impacts on walking and function in people with leg amputation.
Participants will:
- Do ischemic conditioning OR neuromuscular electrical stimulation OR both interventions at home every other day for 2 weeks
- Visit the laboratory before and after completing interventions for the tests
- Visit the laboratory one week after the post intervention visit for follow-up tests
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (추정된)
등록
24
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Nikou Nikoumanesh
- 전화번호: 857-919-4211
- 이메일: nniko@uic.edu
연구 장소
-
-
Illinois
-
Chicago, Illinois, 미국, 60607
- University of Illinois Chicago
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Older than 18 years old
- History of unilateral transfemoral or transtibial amputation
- Able to ambulate independently without the use of aids (i.e., walking cane)
- Able to walk at least 6 minutes continuously without stopping.
- Has a safe residuum with no open wounds on either the residual or intact limb
- Has a prosthetic limb with materials that are sound and safe to withstand the mobility requirements of the study
Exclusion Criteria:
- Younger than 18 years old
- Inability to give informed consent
- Neurological disorder such as multiple sclerosis that affects gait
- Currently pregnant (or intend to become pregnant while participating in study)
- Blood clots in the leg, or any condition in which compression of the thigh or transient ischemia is contraindicated (e.g. open wounds in the leg)
- History of uncontrolled hypertension
- History of heart failure
- Implanted electrical device such as a pacemaker or defibrillator
- Head injury within the previous 6 months
- Seizure disorder
- History of thrombosis
- History of sickle cell trait
- History of genetic disease that impacts gait (e.g. cerebral palsy, muscular dystrophy).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
3
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
활성 비교기: Ischemic Conditioning
|
A blood pressure cuff will be used for ischemic conditioning, which is a non-invasive intervention that involves episodes of muscle ischemia (restriction of blood flow) followed by reperfusion (restoration of blood flow).
|
|
실험적: Neuromuscular Electrical Stimulation
|
Neuromuscular electrical stimulation delivers intermittent electrical impulses to peripheral nerves, inducing involuntary muscle contractions.
|
|
실험적: Neuromuscular Electrical Stimulation + Ischemic Conditioning
|
A blood pressure cuff will be used for ischemic conditioning, which is a non-invasive intervention that involves episodes of muscle ischemia (restriction of blood flow) followed by reperfusion (restoration of blood flow).
Neuromuscular electrical stimulation delivers intermittent electrical impulses to peripheral nerves, inducing involuntary muscle contractions.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in the self-selected gait speed (m/s) at week 3 and 4
기간: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
Participants will be asked to walk at their self-selected gait speed (m/s) for 6 minutes on a split-belt treadmill at the 1st, 9th, and 10th visits.
The change in gait speed from the first visit will be calculated by SPSS v. 31.0
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
Change from baseline in the hip's isometric muscle strength (N.m/kg) using a handheld dynamometer at the 3rd and 4th weeks.
기간: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
Participants will be positioned supine on a treatment table with a neutral position (legs shoulder-width apart) and will hold their arms by their chest.
The handheld dynamometer will be placed at 20 centimeters distal to the greater trochanter.
For participants with shorter residual limbs, the lever arm will be adjusted, and the handheld dynamometer will be placed on the distal side of the residual limb.
Participants will be asked to perform three maximal contractions for 3 to 5 seconds with a 1-minute rest interval for each limb.
The highest score of the three maximal contractions will be used for analysis.
During all strength measurements, verbal encouragement will be given.
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
Changes from baseline in gait kinematics (angle) through gait motion analysis at 3rd and 4th weeks
기간: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
Participants will be asked to walk at their self-selected gait speed for 6 minutes on a split-belt treadmill during their 1st, 9th, and 10th visits.
The changes in gait kinematics (angle) at the ankle, knee, hip joints, and trunk will be analyzed using waveform analysis from the first visit.
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
Changes from baseline in gait kinetics (N.m) through gait motion analysis at 3rd and 4th weeks
기간: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
Participants will be asked to walk at their self-selected gait speed for 6 minutes on a split-belt treadmill during their 1st, 9th, and 10th visits.
The changes in gait kinetics (N.m) at the ankle, knee, hip joints, and trunk will be analyzed using waveform analysis from the first visit.
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes from baseline in daily mobility tasks (%) using the Prosthetic Limb Users Survey of Mobility short form at the 3rd and 4th weeks
기간: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
-Prosthetic Limb Users Survey of Mobility short form is a validated, patient-reported outcome measure used to assess the mobility of adults with lower limb amputations.
It takes about 2 minutes to complete and is widely.
Responses are converted into a standardized T-score.
A score of 50 represents the average mobility of a prosthetic limb user.
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
Changes from baseline in average number of daily steps using an activity monitor at the 3rd and 4th weeks
기간: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
Participants will wear an activity monitor to assess daily steps.
We will compare the average daily steps before and after receiving the assigned interventions.
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
Changes from baseline in the mean seated systolic and diastolic blood pressure (mmHg) at 3rd and 4th weeks
기간: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
|
Changes from baseline in walking economy (mlO₂ /kg.min) at 3rd and 4th weeks
기간: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
Participants will be asked to walk while wearing a silicone face mask at their self-selected gait speed for 6 minutes on a split-belt treadmill during their 1st, 9th, and 10th visits.
Changes in walking economy (ml O₂/kg/min) will be analyzed by assessing the amount of oxygen used (ml O₂), normalized for both body weight (kg) and walking duration (min).
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
Changes from baseline in the carotid-femoral pulse wave velocity (m/s) at the 3rd and 4th weeks
기간: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
Participants will be asked to lay supine on a treatment table for 15 minutes so that blood pressure and cardiac function are similar to basal resting condition for repeatability and to minimize noise.
Central blood pressure and arterial stiffness will be measured using the SphygmoCor.
Carotid-femoral pulse wave velocity is a measure of the time for the arterial pulse to circulate from the carotid to the femoral artery and is considered the gold standard for arterial stiffness measure.
We will measure waveforms on the same side as the intact limb.
All measurements will be made in duplicate and averaged, or triplicate if the difference between two measures is greater than 0.5m/s.
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
Changes from baseline in socket comfort score (out f 10) at the 3rd and 4th weeks
기간: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
The Prosthetic Socket Fit Comfort Score is a validated, 11-point self-report scale (ranging from 0 to 10) used by individuals with amputations and their prosthetists to measure and track the comfort of an artificial limb.
O represents the most uncomfortable socket fit, and 10 represents the most comfortable socket fit.
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
Changes from baseline in quality of life (%) using Nottingham Health Profile at the 3rd and 4th weeks
기간: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
Nottingham Health Profile is a patient-reported questionnaire designed to measure subjective, health-related quality of life.
It takes about 5 minutes to complete and requires simple "yes" or "no" answers.
Scores are calculated using a weighted algorithm and range from 0 (no distress) to 100 (maximum distress).
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
Changes from baseline in the Activities-specific Balance Confidence Scale (%) at the 3rd and 4th weeks
기간: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
The Activities-specific Balance Confidence Scale: For each of the specified activities, participants will indicate the level of confidence in doing the activity without losing their balance or becoming unsteady by choosing one of the percentage points on the scale from 0% (No Confidence) to 100% (Completely Confident)
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
Changes from baseline in Oswestry Low Back Pain (%) at the 3rd and 4th weeks
기간: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
Oswestry Low Back Pain is widely considered the "gold standard" for measuring how lower back or leg pain impacts a patient's daily functional abilities.
This test consists of 10 sections evaluating different aspects of daily living.
For each category, the participant will select the single statement that best describes their situation.
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
|
Changes from baseline in the average sedentary time (s) using an activity monitor at the 3rd and 4th weeks
기간: From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
Participants will wear an activity monitor to calculate the sedentary time (s) per day.
We will compare the average sedentary time before and after receiving the assigned interventions.
|
From enrollment to the end of treatment (post-testing) and follow-up, at 4 weeks of participation
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 7월 1일
기본 완료 (추정된)
기본 완료
2027년 8월 30일
연구 완료 (추정된)
연구 완료
2027년 12월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 6월 4일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 6월 17일
처음 게시됨 (실제)
처음 게시됨
2026년 6월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 6월 24일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 17일
마지막으로 확인됨
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 2026_0262
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
예
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .