- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Omar E Valdés Tapia, PT, MSc, PhD(c)
- Telefonní číslo: +569 74082822
- E-mail: o.valdestapia@uandresbello.edu
Studijní místa
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Providencia
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Santiago, Providencia, Chile
- Nábor
- Clínica Indisa
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Kontakt:
- Claudio Chamorro Lange, PhD
- Telefonní číslo: +569 94398014
- E-mail: claudio.chamorro@unab.cl
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Maximal Voluntary Isometric Contraction
Časové okno: 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.
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Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Rate of Force Development
Časové okno: 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.
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Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Elbow Flexors Voluntary Activation
Časové okno: 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.
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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
Časové okno: 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.
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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
Časové okno: 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.
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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
Časové okno: 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.
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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
Časové okno: 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.
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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
Časové okno: 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.
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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
Časové okno: 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.
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Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Biceps Brachii MMAX Amplitude
Časové okno: 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.
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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
Časové okno: 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.
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Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Biceps Brachii Muscle Thickness
Časové okno: 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.
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Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Upper Limb Function (QuickDASH)
Časové okno: 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.
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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)
Časové okno: 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).
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Baseline, post-immobilization (2-4 weeks), and post-rehabilitation (6-8 weeks)
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Claudio Chamorro Lange, PhD, Universidad Nacional Andres Bello
- Ředitel studie: Luis Peñailillo Escaráte, PhD, Universidad Nacional Andres Bello
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
- Rehabilitace
- Fyzikální terapie
- Elektromyografie
- Transkraniální magnetická stimulace
- Svalová síla
- Odporový trénink
- Imobilizace
- Rehabilitace ramen
- Neuromuskulární funkce
- Excentrické cvičení
- Soustředné cvičení
- Křížové vzdělávání
- Funkce horní končetiny
- Contralateral Training
- Acromioclavicular Joint Injury
Další identifikační čísla studie
- DI-03-CBC/22
- 21261279 (Jiné číslo grantu/financování: ANID/Beca de Doctorado Nacional 2026, Chile.)
- DI-07-25/INI (Jiné číslo grantu/financování: Concurso de Iniciación a la Investigación UNAB 2025, Chile.)
- 24 010884 01 (Jiné číslo grantu/financování: Programme Ambition International 2024, La Région Auvergne Rhône Alpes (France)".)
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Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
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