- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02803255
AAN Robotic Therapy in SCI
Effect of Assist-as-needed Robot Aided Rehabilitation Strategies in Subjects With Incomplete Spinal Cord Injury
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Texas
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Houston, Texas, États-Unis, 77030
- TIRR Memorial Hermann
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Houston, Texas, États-Unis, 77005
- Rice University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Twenty adults with chronic incomplete SCI (according to American Spinal Injury Association (ASIA) Impairment Scale (AIS) C-D level) will be recruited from TIRR and from the Houston area.
Inclusion Criteria:
- Providing written informed consent prior to any study related procedures;
- Age between 18-75 years;
- Diagnosis of chronic complete or incomplete spinal cord injury as defined by the American Spinal Injury Association Impairment scale classification and at least for 6 months;
- Not being involved in any specific exercise program (e.g., NMES, FES) within the previous 3 months;
- No planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
- Eligibility for standard rehabilitation at the time of enrollment (i.e., absence medical comorbidities that would prevent standard rehabilitation);
- No condition (e.g., severe arthritis, extreme shoulder pain) that would interfere with valid administration of the measures or with interpreting motor testing;
Exclusion Criteria: Subjects will be excluded if they have:
- Any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score > than 3 out of 4;
- Subject who cannot provide self-transportation to the study location.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Assist-As-Needed Control
Subjects in this group will interact with a robotic exoskeleton, the MAHI Exo-II, programmed with an "adaptive mode". In this mode, the robot will continuously assist motion along pre-defined trajectories, but will employ an "assist-as-needed" protocol. Here, the amount of assistance provided by the robot will not be always the 100% of that required to complete the task (as in the position control mode), but only a fraction of it. The robot will continuously estimate the residual movement capabilities of the subject, depending on the specific joint addressed in the movement, and will estimate the remaining contribution needed to complete the movement following a predefined trajectory, thus avoiding to over-support motion. |
Autres noms:
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Comparateur actif: Subject-Triggered Control
Subjects in group B will interact with a robotic exoskeleton, the MAHI Exo-II, controlled via the subject-triggered mode, as in a previous clinical trial with the MAHI Exo II robotic system.
In the subject triggered mode, the MAHIExo II is commanded to regulate joints motion following a position-control control scheme, and using as desired trajectories standardized single-joints profiles that require motion of one of the axes of the exoskeleton (i.e.
elbow flexion and extension, forearm pronation and supination, wrist radial and ulnar deviation, wrist flexion and extension).
The switch to position control of the exoskeleton is triggered by the application of sufficient force by the subject, in a previous phase where the robot implements a virtual wall.
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Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Change in ARAT score
Délai: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in Modified Ashworth Scale
Délai: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
|
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Change in Grip Pinch Strength Assessment
Délai: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Change in Graded Redefined Assessment of Strength, Sensibility and Prehension
Délai: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Change in Smoothness metrics
Délai: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Measured via analysis of point-to-point reaching movements performed with the robot.
Extracted measures include the movement-arrest-period-ratio, the spectral arc length, and the normalized average speed
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Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Change in smoothness metrics
Délai: Difference between values measured i) treatment start day and ii) session 10 of the therapy program - 2-4 weeks after treatment start
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Measured via analysis of point-to-point reaching movements performed with the robot.
Extracted measures include the movement-arrest-period-ratio, the spectral arc length, and the normalized average speed
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Difference between values measured i) treatment start day and ii) session 10 of the therapy program - 2-4 weeks after treatment start
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Marcia K. O'Malley, PhD, William Marsh Rice University
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 14-027F
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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