- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01947413
New Protocols in the Treatment of Upper Limb Dysfunctions of Patients With Stroke.
New Protocols in the Treatment of Upper Limb Dysfunctions of Patients With Stroke: An Evidence of Clinical and Kinematic Studies.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
The research program aims at studying patients with stroke the immediate and maintaining effects of new upper-extremity (UE) treatment protocols after brain damage and identifying the possible mechanisms underlying treatment-induced changes in patients with stroke. This research will study new treatment approaches that have been formulated based on principles of integrated central modulation (rTMS) and peripheral modification techniques (BoNTA).
- To compare the movement functions and motor control in patients with stroke of different motor severities.
- To investigate the immediate and maintaining effects of different protocols in the treatment of upper limb functions.
To evaluate motor control and clinical outcomes after different treatment approaches applied in the UE training of patients with stroke. The treatment approaches to be studied will include different protocols. We hypothesize that there will be improvements in movement performance after the treatment and the level of post-treatment performance will differ among the treatments through different reorganization patterns.
3.1 To compare the motor control and clinical outcomes after different treatment approaches.
3.2 To identify the optimal treatment protocol for patients with stroke.
- To investigate the possible predictors of treatment outcome associated with motor severity, movement and participation for each type of treatments. The possible predictors will include brain lesions, and severity. We hypothesize that the proposed prognostic factors will predict treatment outcomes.
- To analyze the association between motor reorganization measured by kinematic study and behavioral improvement in motor severity, movement and participation measured by clinical tools.
Treating motor dysfunction in patients with stroke requires an understanding of the mechanism underlying motor control. Recent reports have suggested BoNTA and rTMS improved motor function in patients with various disorders. However, there are few researches in identifying the optimal rTMS protocol in the treatment of upper limb dysfunctions in patients with stroke. There is lack of literatures in verifying the treatment effect by movement control studies. The current research will offer valuable kinematic data that support neural-motor models proposed to account for motor control problems in these patients. More important, we will identify the new protocol in the treatment of upper limb dysfunctions in patients with stroke through integration of clinical and kinematic measures. We will identify clinical predictors influencing the outcome for different treatment approaches, and analyze the association between motor control and clinical measures involving motor severity, movement and participation. We believe the results of this study will refine services and supports for patients with stroke to meet these goals. This study may potentially provide directions in kinematic measures for future studies on patients with stroke.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Taoyuan, Taiwan, 333
- Chang Gung Memorial Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age: 20-80 y/o
- patients with 1st onset cerebral stroke.
Exclusion Criteria:
- Brain stem or cerebellar stroke
- Contraindication to MRI, such as metallic implant
- Contraindication to BoNTA, such as poor controlled epilepsy
- History of psychiatric disease
- Received BoNTA injection or surgery in recent six months
- Severe psychological impairments, such as mental retardation, autism, or severe Communication problems
- Progressive disorders, such as neurodegenerative disease
- Active medical disease, such as infection
Piano di studio
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: gruppo ITBS
Nella stimolazione theta burst intermittente (gruppo iTBS), hanno ricevuto iTBS (80% della soglia motoria attiva) sull'emisfero interessato.
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In intermittent theta burst stimulation pattern (iTBS) will intermittently give a 2 s train of TBS every 10s for a total of 20 times (low pulse: 600 pulses in total)
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Sperimentale: gruppo cTBS
Nella stimolazione theta burst continua (gruppo cTBS), hanno ricevuto cTBS (80% della soglia motoria attiva) sull'emisfero non interessato.
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In continuous burst stimulation pattern (cTBS) will intermittently give a cTBS treatment consists of a continuous train of TBS for 40 seconds(low pulse: 600 pulses in total).
Altri nomi:
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Comparatore fittizio: falso gruppo TBS
Nella finta stimolazione theta burst (gruppo fittizio TBS), hanno ricevuto una finta stimolazione TBS.
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In sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds(almost no pulse: 600 pulses in total).
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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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Change from baseline of Kinematic analysis after 2 weeks treatment and 3 months , 12 months follow up.
Lasso di tempo: baseline, after treatment, 3 months , 6 months
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Kinematic analysis for upper limb analysis.
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baseline, after treatment, 3 months , 6 months
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 100-0012A3
Piano per i dati dei singoli partecipanti (IPD)
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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 .
Prove cliniche su intermittent theta burst stimulation
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University of Sao PauloSconosciutoDisordine depressivo | Disordine bipolare | Episodio depressivoBrasile
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University of Sao PauloAttivo, non reclutante
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University Hospital TuebingenCompletatoGrave depressioneGermania
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Jung-Sun LeeSeoul St. Mary's Hospital, The Catholic University; Seoul National University... e altri collaboratoriNon ancora reclutamentoDisturbo depressivo maggiore (MDD) | Depressione - Disturbo depressivo maggioreCorea del Sud
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Erika ForbesNational Institute of Mental Health (NIMH)Completato
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Università degli Studi di BresciaReclutamentoFTD | FTLD | P.P.A | rTMS | PSP | Sindrome corticale basale (CBS) | bvFTD | Stimolazione a scoppio di ThetaItalia
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Institute of Mental Health NottinghamCompletato
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Nicholas Balderston, PhDReclutamentoConnettività cerebraleStati Uniti
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Centre for Addiction and Mental HealthUniversity Health Network, TorontoCompletatoDisturbi di dismorfismo corporeoCanada
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King's College LondonSouth London and Maudsley NHS Foundation TrustReclutamento