- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01968096
The Reversal of Neuromuscular Adaptation in Human With Spinal Cord Injury II
Following injury to the spinal cord, the spinal circuit undergoes a series of adaptations. In parallel with the spinal circuit adaptation, the muscular properties also adapt. In human and animal studies, histochemical and physiological evidences showed that the paralyzed muscle transferred from slow, fatigue-resistant to fast, fatigable after injury.
Reversal of neuromuscular property for persons with SCI needs to be resolved. Studies using high load electrical stimulations showed a reverse change of muscular properties, such as hypertrophy and reversal of fiber type transformations but failed to show a reversal of spinal circuitry function. Previous studies found that fast continuous passive motion (CPM) altered the H reflex excitability in human. Animal studies found that passive cycling and passive stretching delayed atrophy and influenced the transition of type I and IIa MHC. Theses findings lead to a hypothesis that mechanical stimulation might be able to reverse both spinal circuitry and muscular properties after SCI but it has not been confirmed in human study.
The purpose of this project is to investigate the effect of mechanical stimulation by fast CPM on the reversing adaptation of human paralyzed muscle after SCI.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Taoyuan, Taïwan, 333
- Recrutement
- Chang Gung University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Stage 1 subjects: Spinal cord injury subject
Inclusion Criteria:
- Clinical diagnosis of spinal cord injury < 2 years
Stage 2 subjects: Incomplete spinal cord injury subject
Inclusion Criteria:
- Clinical diagnosis of incomplete spinal cord injury
- ASIA classification:B, C, or D
Stage 3 subjects: Spinal cord injury subjects with high muscle tone
Inclusion Criteria:
- Clinical diagnosis of spinal cord injury.
- ASIA classification: A, B, C, or D
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: SCI subjects
Stage 1 subjects: pilot study:understand post activation depression with spinal cord injury to avoid the influence of the suprasegmental level.
|
|
|
Aucune intervention: Incomplete SCI subjects
Stage 2 subjects: pilot study:The strength of depression will be evaluated in individuals with and without SCI.
|
|
|
Aucune intervention: Health subjects
Stage 2 subjects: pilot study:The strength of depression will be evaluated in individuals with and without SCI.
|
|
|
Expérimental: SCI subjects with high muscle tone (High frequency)
Stage 3 subjects:A rehabilitation program of machine driven passive stretch(High frequency) will be executed .
|
A rehabilitation program of machine driven passive stretch.
|
|
Expérimental: SCI subjects with high muscle tone(low frequency)
Stage 3 subjects:A rehabilitation program of machine driven passive stretch(Low frequency) will be executed.
|
A rehabilitation program of machine driven passive stretch.
|
|
Aucune intervention: SCI subjects with high muscle tone
Stage 3 subjects:Control subjects
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Clinical muscle tone tests & Peripheral nerve Stimulation machine
Délai: Participants will be followed for the duration of invention, an expected average of 24 weeks.
|
Clinical muscle tone test include Modified Ashworth Scale, Pendulum test ,and withdraw reflex,etc.. Normalization of muscle tone, and influence of muscle property will be evaluated. Peripheral nerve Stimulation machine stimulate Soleus and Tibialis anterior. Restoration of post activation will be evaluated. |
Participants will be followed for the duration of invention, an expected average of 24 weeks.
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
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
- 102-1780C
- NSC102-2314-B-182-021-MY2
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 .