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

4 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

16

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Actieve vergelijker: 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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Maximal Voluntary Isometric Contraction
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Elbow Flexors Voluntary Activation
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Universidad Nacional Andres Bello

Onderzoekers

  • Studie directeur: Claudio Chamorro Lange, PhD, Universidad Nacional Andres Bello
  • Studie directeur: Luis Peñailillo Escaráte, PhD, Universidad Nacional Andres Bello

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 januari 2026

Primaire voltooiing (Geschat)

1 juli 2027

Studie voltooiing (Geschat)

1 juli 2027

Studieregistratiedata

Eerst ingediend

29 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 mei 2026

Eerst geplaatst (Werkelijk)

5 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

4 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

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

IPD-toegangscriteria voor delen

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.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ANALYTIC_CODE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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