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L'essai clinique NCT07254247 pour Amputation est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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A Unique Body-Powered Terminal Device With Enhanced Grasping Capabilities for Individuals With Upper Limb Loss
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L'étude clinique NCT07254247 est un essai interventionnel pour Amputation. Son statut actuel est : en recrutement. L'étude a débuté le 20 novembre 2025 et vise à recruter 8 participants. Dirigé par Little Room Innovations, LLC, l'essai devrait être terminé d'ici le 1 janvier 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 28 novembre 2025.
Résumé succinct
We have developed a novel terminal device for a prosthetic arm that eliminates the functional tradeoffs seen in body-powered voluntary open devices. The primary goal of this study is to validate the performance of the device against the commercial state-of-the-art in upper limb terminal devices.
Titre officiel
A Unique Body-Powered Terminal Device With Enhanced Grasping Capabilities for Individuals With Upper Limb Loss
Conditions
AmputationAutres identifiants de l'essai
Numéro NCT
Date de début (réel)
2025-11-20
Dernière mise à jour publiée
2025-11-28
Date de fin (estimée)
2026-01
Inscription (estimée)
8
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Objectif principal
Recherche fondamentale
Plan d'attribution
Randomisé
Modèle d'intervention
Croisé
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalNovel Prosthetic Hook, then Control Hook (Light Spring), then Control Hook (Heavy Spring) In this arm, participants will first complete the tests with the Novel Prosthetic Hook and then the Control Hook with a light return spring, then the Control Hook with a heavy return spring. | Novel Prosthetic Hook The Novel Prosthetic Hook is the investigational device that is being studied for its performance as an upper limb terminal device. Control Hook (Light Spring) The Control Hook is a standard, commercially available prosthetic hook used as a comparison. In this intervention, it is configured with a light return spring. Control Hook (Heavy Spring) The Control Hook is a standard, commercially available prosthetic hook used as a comparison. In this intervention, it is configured with a heavy return spring. |
ExpérimentalNovel Prosthetic Hook, then Control Hook (Heavy Spring), then Control Hook (Light Spring) In this arm, participants will first complete the tests with the Novel Prosthetic Hook and then the Control Hook with a heavy return spring, then the Control Hook with a light return spring. | Novel Prosthetic Hook The Novel Prosthetic Hook is the investigational device that is being studied for its performance as an upper limb terminal device. Control Hook (Light Spring) The Control Hook is a standard, commercially available prosthetic hook used as a comparison. In this intervention, it is configured with a light return spring. Control Hook (Heavy Spring) The Control Hook is a standard, commercially available prosthetic hook used as a comparison. In this intervention, it is configured with a heavy return spring. |
ExpérimentalControl Hook (Light Spring), then Control Hook (Heavy Spring), then Novel Prosthetic Hook In this arm, participants will first complete the tests with the Control Hook with a light return spring, then the Control Hook with a heavy return spring, and then the Novel Prosthetic Hook. | Novel Prosthetic Hook The Novel Prosthetic Hook is the investigational device that is being studied for its performance as an upper limb terminal device. Control Hook (Light Spring) The Control Hook is a standard, commercially available prosthetic hook used as a comparison. In this intervention, it is configured with a light return spring. Control Hook (Heavy Spring) The Control Hook is a standard, commercially available prosthetic hook used as a comparison. In this intervention, it is configured with a heavy return spring. |
ExpérimentalControl Hook (Heavy Spring), then Control Hook (Light Spring), then Novel Prosthetic Hook In this arm, participants will first complete the tests with the Control Hook with a heavy return spring, then the Control Hook with a light return spring, and then the Novel Prosthetic Hook. | Novel Prosthetic Hook The Novel Prosthetic Hook is the investigational device that is being studied for its performance as an upper limb terminal device. Control Hook (Light Spring) The Control Hook is a standard, commercially available prosthetic hook used as a comparison. In this intervention, it is configured with a light return spring. Control Hook (Heavy Spring) The Control Hook is a standard, commercially available prosthetic hook used as a comparison. In this intervention, it is configured with a heavy return spring. |
ExpérimentalControl Hook (Light Spring), then Novel Prosthetic Hook, then Control Hook (Heavy Spring) In this arm, participants will first complete the tests with the Control Hook with a light return spring, then the Novel Prosthetic Hook, and then the Control Hook with a heavy return spring, | Novel Prosthetic Hook The Novel Prosthetic Hook is the investigational device that is being studied for its performance as an upper limb terminal device. Control Hook (Light Spring) The Control Hook is a standard, commercially available prosthetic hook used as a comparison. In this intervention, it is configured with a light return spring. Control Hook (Heavy Spring) The Control Hook is a standard, commercially available prosthetic hook used as a comparison. In this intervention, it is configured with a heavy return spring. |
ExpérimentalControl Hook (Heavy Spring), then Novel Prosthetic Hook, then Control Hook (Light Spring) In this arm, participants will first complete the tests with the the Control Hook with a heavy return spring, then Novel Prosthetic Hook, and then the Control Hook with a light return spring. | Novel Prosthetic Hook The Novel Prosthetic Hook is the investigational device that is being studied for its performance as an upper limb terminal device. Control Hook (Light Spring) The Control Hook is a standard, commercially available prosthetic hook used as a comparison. In this intervention, it is configured with a light return spring. Control Hook (Heavy Spring) The Control Hook is a standard, commercially available prosthetic hook used as a comparison. In this intervention, it is configured with a heavy return spring. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Modified SHAP Average Completion Time | This is the average task completion time across all tasks performed in a modified version of the Southampton Hand Assessment Protocol (SHAP). The SHAP has been modified in this study to include only the relevant assessments to the prosthetic hooks being tested. A lower average score indicates better performance. | through study completion, an average of 1 day |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Clothespin Relocation Task Average Time | This is a functional hand assessment that measures the time it takes to reposition clothespins of differing stiffnesses. Lower completion times indicate better performance. | through study completion, an average of 1 day |
Borg Rating of Perceived Exertion (RPE) | This is a scale of 0 to 10 with 0 indicated by the participate as a measure of how difficult a task is. | through study completion, an average of 1 day |
NASA Task Load Index | The NASA Task Load Index method assesses work load. The aggregate score reported scales from 0 to 100, where 100 indicates the maximum (hardest) workload. | through study completion, an average of 1 day |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
Are between the ages of 18-80 Are proficient in English Able to demonstrate proper functioning and safety of the terminal device
Have visual or mental impairments Have history of neurological or musculoskeletal disorders
Little Room Innovations, LLCUniversité du Michigan487 essais cliniques actifs à explorerContact central de l'essai
Contact: Brian Lawson, PhD, 317-691-1604, [email protected]
Contact: Harrison Bartlett, PhD, 205-862-0912, [email protected]
1 Centres de l'essai dans 1 pays
Michigan
University of Michigan, Ann Arbor, Michigan, 48109, United States
Deanna Gates, PhD, Contact, 734-647-2698, [email protected]
En recrutement