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Contralateral Resistance Training During Immobilization in Patients With Acromioclavicular Joint Injury (CROSS-ACD)

4 juin 2026 mis à jour par: Omar Esteban Valdés Tapia, Universidad Nacional Andres Bello

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

16

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chili
    • Providencia
      • Santiago, Providencia, Chili
        • Recrutement
        • Clínica Indisa
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: Contralateral Eccentric Resistance Training
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.
Comparateur actif: 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.
Comportemental: Contralateral Concentric Resistance Training
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Maximal Voluntary Isometric Contraction
Délai: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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)
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Rate of Force Development
Délai: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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)
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Elbow Flexors Voluntary Activation
Délai: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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: %
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Biceps Brachii Motor Supramaximal Response Amplitude
Délai: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Biceps Brachii Motor Evoked Potential Amplitude
Délai: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Motor evoked potential (MEP) amplitude elicited by transcranial magnetic stimulation and normalized to peripheral responses to assess corticospinal excitability. Unit: mV
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Biceps Brachii Silent Period Duration
Délai: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Duration of the electromyographic silent period following transcranial magnetic stimulation during voluntary contractions as an indicator of cortical inhibition. Unit: ms
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Biceps Brachii Short-Interval Intracortical Inhibition
Délai: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Short-interval intracortical inhibition assessed using paired-pulse transcranial magnetic stimulation as an index of intracortical inhibitory function. Unit: mV
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Biceps Brachii Cervicomedullary Motor Evoked Potential Amplitude
Délai: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Motor unit discharge characteristics assessed using high-density surface electromyography, including discharge rate, recruitment thresholds, and estimates of intrinsic motoneuron properties. Unit: mV
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Biceps Brachii Motor Unit Behavior
Délai: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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)
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Biceps Brachii MMAX Amplitude
Délai: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Biceps Brachii Peripheral Contractile Properties
Délai: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Evoked twitch and doublet force responses obtained using peripheral nerve stimulation to assess muscle contractile function. Unit: N
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Biceps Brachii Muscle Thickness
Délai: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Muscle thickness assessed by B-mode ultrasonography as an indicator of muscle morphology and preservation during immobilization and rehabilitation. Unit: mm
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Upper Limb Function (QuickDASH)
Délai: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Upper-limb disability and functional status assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. Unit: 0-100 points
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Health-Related Quality of Life (SF-36)
Délai: Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36). Unit: 0-100 points
Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Universidad Nacional Andres Bello

Les enquêteurs

  • Directeur d'études: Claudio Chamorro Lange, PhD, Universidad Nacional Andres Bello
  • Directeur d'études: Luis Peñailillo Escaráte, PhD, Universidad Nacional Andres Bello

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2026

Achèvement primaire (Estimé)

1 juillet 2027

Achèvement de l'étude (Estimé)

1 juillet 2027

Dates d'inscription aux études

Première soumission

29 mai 2026

Première soumission répondant aux critères de contrôle qualité

29 mai 2026

Première publication (Réel)

5 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • DI-03-CBC/22
  • 21261279 (Autre subvention/numéro de financement: ANID/Beca de Doctorado Nacional 2026.Chile)
  • DI-07-25/INI (Autre subvention/numéro de financement: Concurso de Iniciación a la Investigación UNAB 2025,Chile)
  • 24 010884 01 (Autre subvention/numéro de financement: Programme Ambition International 2024, La Région Auvergne Rhône Alpes,France)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

De-identified individual participant data underlying the results reported in publications arising from this study will be made available to qualified researchers upon reasonable request. Shared data may include demographic characteristics, clinical outcomes, force production measurements, neuromuscular assessments, electromyographic recordings, transcranial magnetic stimulation outcomes, peripheral nerve stimulation outcomes, and questionnaire-derived scores. Data will be provided in a de-identified format to protect participant confidentiality.

Délai de partage IPD

Data will become available beginning 6 months following publication of the primary study results and will remain available for a period of 5 years.

Critères d'accès au partage IPD

Researchers who provide a methodologically sound proposal and whose intended use of the data has been approved by the study investigators may access the data. Requests should be directed to the Principal Investigator. Data will be shared through a secure institutional repository or encrypted electronic transfer following execution of an appropriate data-sharing agreement.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • ANALYTIC_CODE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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