- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07615062
Cross-education of Skill and Strength in Healthy People Subjected to an Upper-limb Disuse Model (IMMO-CROSS)
22 maggio 2026 aggiornato da: Iván Alejandro Cuyul Vásquez, Universidad Catolica de Temuco
Cross-education of Skill and Strength Through Contralateral Manual Dexterity Training in Healthy Young Adults Subjected to an Upper-limb Disuse Model: A Randomized Controlled Trial.
This randomized controlled trial aims to compare manual dexterity and strength between a group undergoing a contralateral manual dexterity training program and a no-intervention control group in healthy, physically inactive individuals subjected to an induced upper-limb disuse model.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Cross-education of skill offers promising opportunities for the rehabilitation of upper-limb musculoskeletal injuries.
An approach based on contralateral manual dexterity training could accelerate functional recovery, reduce motor skill loss during periods of immobilization, and optimize conventional rehabilitation protocols.
However, controlled studies are needed to analyze the efficacy of specific unilateral training protocols designed to maximize cross-education before clinical translation.
To date, no experimental studies have been published on healthy individuals subjected to upper-limb disuse models alongside contralateral skill training involving functional tasks.
This cross-education effect could potentially prevent the loss of manual dexterity and strength that occurs during immobilization.
For this research, a contralateral manual dexterity training protocol was developed based on the functional limitations commonly experienced by individuals with forearm and hand musculoskeletal injuries (e.g., distal radius fractures, wrist sprains, carpal tunnel syndrome, and tendinopathies).
Additionally, the protocol incorporates characteristics from training programs that have demonstrated the greatest cross-education effect.
Tipo di studio
Interventistico
Iscrizione (Stimato)
34
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Iván A. Cuyul-Vásquez, PhD(c)
- Numero di telefono: +56452205205
- Email: icuyul@uct.cl
Luoghi di studio
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Araucania
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Temuco, Araucania, Chile, 4813302
- UCT, Facultad de ciencias de la Salud
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Contatto:
- Iván A. Cuyul-Vásquez, PhD(c)
- Numero di telefono: +56452205205
- Email: icuyul@uct.cl
-
Contatto:
- Cuyul-Vásquez Iván Cuyul-Vásquez, PhD(C)
- Numero di telefono: +56452205205
- Email: icuyul@uct.cl
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Sì
Descrizione
Inclusion Criteria:
- Individuals will be eligible for inclusion if they are right-handed adults aged 18 to 35 years with a body mass index (BMI) between 18.5 and 30 kg/m².
- Individuals must be classified as physically inactive, defined as not meeting the World Health Organization criteria of at least 150 minutes of moderate-intensity physical activity or 75 minutes of vigorous-intensity physical activity per week.
Exclusion Criteria:
- Individuals who have engaged in physical training (e.g., any form of strength or aerobic exercise) or specific manual dexterity training within the past 6 months. - Individuals who regularly participate in artistic, occupational, or sporting activities requiring high levels of manual dexterity (e.g., musicians, gamers, craftspeople).
- Individuals with a history of orthopedic or traumatic injuries affecting either upper extremity. Individuals with pathologies or conditions that preclude safe training (e.g., uncontrolled hypertension, or visual, auditory, or cognitive impairments [for example, dyscalculia]).
- Individuals currently using nutritional supplements or medications that interfere with the regulation of skeletal muscle mass and strength (e.g., whey protein, creatine) or the central nervous system (e.g., antidepressants, anxiolytics, hypnotics).
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Contralateral manual dexterity training
Participants in the experimental group will perform contralateral manual dexterity training focused on moving 0.5, 1.0, or 1.5 kg cylinders using different grips and movements across various planes on a gridded board.
Participants will execute various grips to place the cylinders into the quadrants indicated on a smartphone screen.
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The subjects in the experimental group will perform contralateral manual dexterity training focused on moving cylinders of 0.5, 1 or 1.5 kilos with grips and movements in different planes on a gridded board.
Participants will have to develop different grips and place the cylinders in the quadrants indicated on a smartphone screen.
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Nessun intervento: Control group without intervention
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Fine Manual Dexterity
Lasso di tempo: Baseline and day 7
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Fine manual dexterity will be assessed using the Functional Dexterity test (FDT).
Using a stopwatch, the evaluator records the total time in seconds that the participant takes to complete the task.
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Baseline and day 7
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Force control
Lasso di tempo: Baseline and day 7
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In a seated position with the elbow flexed, participants will perform isometric contractions to reach a target torque guided by real-time visual feedback.
The accuracy of maintaining these contractions in the wrist flexor and extensor muscles will be assessed using a Humac Norm isokinetic dynamometer (Computer Sports Medicine, Inc., Stoughton, MA, USA).
Participants will perform a continuous 60-second isometric contraction exercise.
During this period, participants will adjust their force level to between 10% and 30% of their maximum voluntary contraction (MVC) at 10-second intervals.
Three attempts will be performed per limb.
The Root Mean Square Error (RMSE) will be recorded.
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Baseline and day 7
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Gross Manual Dexterity
Lasso di tempo: Baseline and day 7
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This gross manual dexterity will be assessed using the same task performed during the experimental group's contralateral manual dexterity training.
Specifically, participants will complete 15 trials, moving cylinders of varying weights across a gridded board following a sequence displayed on a smartphone.
The time required to complete these 15 trials will be recorded.
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Baseline and day 7
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Handgrip strength
Lasso di tempo: Baseline and day 7
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Maximum lumbrical and cylindrical grip strength will be assessed using a Jamar Plus+ digital hand dynamometer.
The highest value from three attempts will be recorded for each assessment
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Baseline and day 7
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Joint Position Sense Test
Lasso di tempo: Baseline and day 7
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Proprioception: Wrist flexion-extension joint position sense will be assessed using the Joint Position Sense Test (JPST).
All measurements will be conducted with a Humac Norm isokinetic dynamometer (Computer Sports Medicine, Inc., Stoughton, MA, USA).
Three attempts will be made per limb.
The absolute error (difference in degrees between 30° and the angle achieved during the test) will be recorded.
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Baseline and day 7
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Left/right judgment
Lasso di tempo: Baseline and day 7
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Left/right judgment will be assessed using the Recognise™ application (Noigroup, Adelaide, Australia).
Performance on the laterality judgment task was quantified using the Inverse Efficiency Score (IES), calculated as the average reaction time of correct responses divided by the proportion of correct responses (IES = RT / PC). 3 blocks of 20 images (60 images total).
Maximum exposure time: 5 seconds per image.
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Baseline and day 7
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Physical activity level
Lasso di tempo: Baseline and day 7
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Weekly metabolic equivalents (MET-min/week) will be calculated using the validated Spanish version of the Global physical activity questionnaire (GPAQ).
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Baseline and day 7
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Psychological Distress
Lasso di tempo: Baseline
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Psychological Distress, including symptoms of depression, anxiety, and stress, will be assessed using the 21-item Depression, Anxiety and Stress Scale (DASS-21).
This self-report instrument will be used to quantify the severity of emotional distress across these three domains.
This scale has a minimum score of 0 and a maximum of 126 points (total score calculated by doubling the sum of the 21 items).
Higher scores in DASS-21 indicate greater psychological distress.
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Baseline
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Sleep Quality:
Lasso di tempo: Baseline
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Sleep disturbances and overall sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI).
This scale has a minimum score of 0 and a maximum of 21 points (higher scores indicate worse sleep quality)
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Baseline
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Daily steps
Lasso di tempo: During 7 days of immobilization
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Physical activity will be monitored using a Xiaomi Band 9 smartwatch (number of daily steps), which participants will wear throughout the seven-day mobilization period.
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During 7 days of immobilization
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Sleep time
Lasso di tempo: During 7 days of immobilization
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Sleep time will be measured using a Xiaomi Band 9 smartwatch (hours), which participants will wear throughout the seven-day immobilization period.
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During 7 days of immobilization
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
25 maggio 2026
Completamento primario (Stimato)
1 ottobre 2026
Completamento dello studio (Stimato)
30 gennaio 2027
Date di iscrizione allo studio
Primo inviato
14 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
22 maggio 2026
Primo Inserito (Effettivo)
29 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
29 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
22 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- INMO-CROSS-2026
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .