- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07615062
Cross-education of Skill and Strength in Healthy People Subjected to an Upper-limb Disuse Model (IMMO-CROSS)
22 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
34
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
- Nom: Iván A. Cuyul-Vásquez, PhD(c)
- Numéro de téléphone: +56452205205
- E-mail: icuyul@uct.cl
Lieux d'étude
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Araucania
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Temuco, Araucania, Chili, 4813302
- UCT, Facultad de ciencias de la Salud
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Contact:
- Iván A. Cuyul-Vásquez, PhD(c)
- Numéro de téléphone: +56452205205
- E-mail: icuyul@uct.cl
-
Contact:
- Cuyul-Vásquez Iván Cuyul-Vásquez, PhD(C)
- Numéro de téléphone: +56452205205
- E-mail: icuyul@uct.cl
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-
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
Oui
La description
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).
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: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: Control group without intervention
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Fine Manual Dexterity
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Handgrip strength
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Physical activity level
Délai: 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
Délai: 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:
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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 (Estimé)
25 mai 2026
Achèvement primaire (Estimé)
1 octobre 2026
Achèvement de l'étude (Estimé)
30 janvier 2027
Dates d'inscription aux études
Première soumission
14 mai 2026
Première soumission répondant aux critères de contrôle qualité
22 mai 2026
Première publication (Réel)
29 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
29 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- INMO-CROSS-2026
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
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Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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