- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07628361
Contralateral Resistance Training During Immobilization in Patients With Acromioclavicular Joint Injury (CROSS-ACD)
Effects of Contralateral Eccentric and Concentric Resistance Training During Immobilization on Neuromuscular Function, Functional Recovery, and Quality of Life in Patients With Acromioclavicular Joint Injury: A Randomized Controlled Trial
This randomized controlled trial aims to compare the effects of contralateral eccentric and concentric resistance training performed during the immobilization period following acromioclavicular joint injury. Immobilization is commonly prescribed after injury but may lead to reductions in muscle mass, neuromuscular function, force production, and upper-limb functionality.
Contralateral resistance training, also known as cross-education training, involves exercising the non-injured limb to induce beneficial adaptations in the immobilized limb through neural mechanisms. While both eccentric and concentric exercise may produce contralateral effects, their relative effectiveness in a clinical population remains unclear.
Participants with acute acromioclavicular joint injury requiring sling immobilization will be randomly assigned to either a contralateral eccentric training group or a contralateral concentric training group. During immobilization, participants will perform supervised resistance training with the non-injured upper limb. Following immobilization, all participants will receive the same standardized rehabilitation program.
Neuromuscular function, muscle morphology, force production, upper-limb function, and quality of life will be assessed before immobilization, after immobilization, and following rehabilitation. The findings may contribute to the development of more effective rehabilitation strategies for patients recovering from upper-limb injuries requiring temporary immobilization.
연구 개요
상태
상세 설명
Acromioclavicular joint injury is one of the most common shoulder injuries in physically active individuals. Temporary immobilization using a sling is frequently prescribed during the acute phase of recovery; however, immobilization can result in rapid declines in muscle strength, muscle mass, neuromuscular function, and upper-limb performance.
Cross-education is a neurophysiological phenomenon whereby unilateral resistance training induces adaptations in the contralateral untrained limb. Previous experimental studies have demonstrated that resistance exercise performed with the non-immobilized limb may attenuate strength loss and neuromuscular impairments in an immobilized limb. However, the relative effectiveness of different muscle contraction modes during cross-education training in clinical populations remains poorly understood.
The purpose of this randomized controlled trial is to compare the effectiveness of contralateral eccentric versus contralateral concentric resistance training performed during the immobilization period in patients with acromioclavicular joint injury. Participants will be randomly allocated to one of two intervention groups: (1) contralateral eccentric resistance training or (2) contralateral concentric resistance training. Both interventions will be performed using the non-injured upper limb during the period of prescribed sling immobilization.
Participants will undergo comprehensive assessments before immobilization, immediately after immobilization, and after completion of a standardized rehabilitation program. Outcomes will include measures of neuromuscular function obtained through peripheral nerve stimulation, transcranial magnetic stimulation, electromyography, and voluntary force assessments. Muscle morphology will be evaluated using ultrasound imaging, while upper-limb function and quality of life will be assessed using validated clinical questionnaires.
Following immobilization, all participants will receive the same rehabilitation program focused on restoring shoulder stability, muscle strength, and functional capacity. The primary objective is to determine whether eccentric or concentric contralateral resistance training more effectively preserves neuromuscular function and facilitates recovery following immobilization.
The results of this study may provide evidence to optimize rehabilitation strategies for patients with acromioclavicular joint injuries and other musculoskeletal conditions requiring temporary upper-limb immobilization.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Omar E Valdés Tapia, PT, MSc, PhD(c)
- 전화번호: +569 74082822
- 이메일: o.valdestapia@uandresbello.edu
연구 장소
-
-
Providencia
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Santiago, Providencia, 칠레
- 모병
- Clínica Indisa
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연락하다:
- Claudio Chamorro Lange, PhD
- 전화번호: +569 94398014
- 이메일: claudio.chamorro@unab.cl
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Men and women aged 18 to 36 years.
- Diagnosis of acute acromioclavicular joint injury confirmed by an orthopedic surgeon.
- Physician-prescribed upper-limb immobilization using a sling for approximately 2 to 4 weeks, with or without surgical repair.
- Ability to understand study procedures and provide written informed consent.
- Medical clearance to participate in the rehabilitation and resistance training program.
Exclusion Criteria:
- Previous surgery or severe musculoskeletal injury affecting either upper limb within the previous 12 months.
- Neurological disorders affecting motor function or neuromuscular performance.
- Contraindications to transcranial magnetic stimulation according to established safety guidelines.
- Current participation in another clinical trial or structured upper-limb rehabilitation program.
- Cognitive impairment or inability to comply with study procedures.
- Pregnancy.
- Any medical condition that, in the opinion of the investigators, may compromise participant safety or study participation.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Contralateral Eccentric Training
Participants will perform supervised contralateral eccentric resistance training with the non-injured upper limb during the period of physician-prescribed sling immobilization following acute acromioclavicular joint injury, with or without surgical repair.
The immobilization period is expected to last approximately 2 to 4 weeks depending on clinical management.
Following immobilization, participants will complete a standardized 4-week rehabilitation program.
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Supervised unilateral eccentric elbow flexor training performed with the non-injured limb during sling immobilization (2-4 weeks).
Training is performed 3 times/week, 5 sets of 8-12 repetitions at 60-90% 1RM, with 4-second contractions and 3-minute rest intervals between sets.
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활성 비교기: Contralateral Concentric Training
Participants will perform supervised contralateral concentric resistance training with the non-injured upper limb during the period of physician-prescribed sling immobilization following acute acromioclavicular joint injury, with or without surgical repair.
The immobilization period is expected to last approximately 2 to 4 weeks depending on clinical management.
Following immobilization, participants will complete the same standardized 4-week rehabilitation program.
|
Supervised unilateral concentric elbow flexor training performed with the non-injured limb during sling immobilization (2-4 weeks).
Training is performed 3 times/week, 5 sets of 8-12 repetitions at 60-90% 1RM, with 4-second contractions and 3-minute rest intervals between sets.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Maximal Voluntary Isometric Contraction
기간: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Maximal voluntary isometric force of the injured upper limb assessed using a calibrated dynamometer.
Force values will be recorded during standardized maximal isometric contractions and used to evaluate changes in muscle performance throughout immobilization and rehabilitation.
Unit: Newtons (N)
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Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Rate of Force Development
기간: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Rate of force development (RFD) of the injured upper limb assessed during maximal voluntary isometric contractions using a calibrated dynamometer.
RFD will be calculated from the force-time curve and used as an indicator of explosive force production and neuromuscular performance.
Unit: N·s-¹ (N/s)
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Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Elbow Flexors Voluntary Activation
기간: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Voluntary activation of the elbow flexors assessed using the interpolated twitch technique during maximal voluntary isometric contractions.
Values will be expressed as a percentage of voluntary neural drive to the muscle.
Unit: %
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Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Biceps Brachii Motor Supramaximal Response Amplitude
기간: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Peak-to-peak amplitude of the motor supramaximal response (MSUP) evoked by peripheral nerve stimulation during submaximal contractions as an indicator of motor pathway excitability.
Unit: mV
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Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Biceps Brachii Motor Evoked Potential Amplitude
기간: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Motor evoked potential (MEP) amplitude elicited by transcranial magnetic stimulation and normalized to peripheral responses to assess corticospinal excitability.
Unit: mV
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Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Biceps Brachii Silent Period Duration
기간: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Duration of the electromyographic silent period following transcranial magnetic stimulation during voluntary contractions as an indicator of cortical inhibition.
Unit: ms
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Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Biceps Brachii Short-Interval Intracortical Inhibition
기간: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Short-interval intracortical inhibition assessed using paired-pulse transcranial magnetic stimulation as an index of intracortical inhibitory function.
Unit: mV
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Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Biceps Brachii Cervicomedullary Motor Evoked Potential Amplitude
기간: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Motor unit discharge characteristics assessed using high-density surface electromyography, including discharge rate, recruitment thresholds, and estimates of intrinsic motoneuron properties.
Unit: mV
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Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Biceps Brachii Motor Unit Behavior
기간: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Motor unit discharge characteristics assessed using high-density surface electromyography, including discharge rate, recruitment thresholds, and estimates of intrinsic motoneuron properties.
Unit: pulses/s (pps)
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Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Biceps Brachii MMAX Amplitude
기간: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Peak-to-peak amplitude of the maximal compound muscle action potential (MMAX) evoked by peripheral nerve stimulation as an indicator of peripheral excitability.
Unit: mV
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Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Biceps Brachii Peripheral Contractile Properties
기간: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Evoked twitch and doublet force responses obtained using peripheral nerve stimulation to assess muscle contractile function.
Unit: N
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Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Biceps Brachii Muscle Thickness
기간: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Muscle thickness assessed by B-mode ultrasonography as an indicator of muscle morphology and preservation during immobilization and rehabilitation.
Unit: mm
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Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Upper Limb Function (QuickDASH)
기간: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Upper-limb disability and functional status assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire.
Unit: 0-100 points
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Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Health-Related Quality of Life (SF-36)
기간: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36).
Unit: 0-100 points
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Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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공동 작업자 및 조사자
수사관
- 연구 책임자: Claudio Chamorro Lange, PhD, Universidad Nacional Andres Bello
- 연구 책임자: Luis Peñailillo Escaráte, PhD, Universidad Nacional Andres Bello
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
키워드
기타 연구 ID 번호
- DI-03-CBC/22
- 21261279 (기타 보조금/기금 번호: ANID/Beca de Doctorado Nacional 2026.Chile)
- DI-07-25/INI (기타 보조금/기금 번호: Concurso de Iniciación a la Investigación UNAB 2025,Chile)
- 24 010884 01 (기타 보조금/기금 번호: Programme Ambition International 2024, La Région Auvergne Rhône Alpes,France)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
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