- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03608527
Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis
The Impact of Motor Rehabilitation on the Dynamic Properties of the Brain: Towards the Individual Tailoring of Therapeutic Interventions in Multiple Sclerosis Patients
Motor learning can induce significant changes in the human brain through neural plasticity processes, which play a crucial role in the brain functional reorganization in response to external stimuli and/or to pathological conditions. For example, people with multiple sclerosis present motor deficits often associated with cerebral activity alteration. However, whether these brain activation changes contribute to or protect against motor performance deficits still needs to be determined.
Moreover, rehabilitation protocols could be designed to obtain efficient brain adaptation to preserve patients' outcome, but consistent data on the real efficacy of rehabilitative procedures are lacking, in particular concerning the rehabilitation effect on brain networks.
Therefore, this project focuses on the degree to which imaging measures of functional brain activity can give new hints on the effects of motor rehabilitative protocols in multiple sclerosis patients' performance. Particularly, the investigator's aim is to investigate the effects of upper limb rehabilitation, focused on hand motor function, and the correlation between motor performance and functional magnetic resonance data.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Multiple sclerosis diagnosis according to McDonald criteria
- right handedness as assessed by the Edinburgh Handedness Inventory
- absence of relapses in the last three months
- mild or moderate sensorimotor impairment in one or both upper limbs as evaluated by means of the Medical Research Council scale (grade 3-4)
Exclusion Criteria:
- steroid-use or a worsening of the Expanded Disability Status Scale (EDSS) score in the last three months
- psychiatric disorders
- severe cognitive impairment
- magnetic resonance imaging contraindications
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Active motor treatment (AMT) group
15 people with multiple sclerosis performing a 8 week rehabilitative treatment based on task-oriented voluntary exercises (3 sessions/week).
|
Exercises for neuromuscular control to improve proprioceptive sensibility, muscle strength, stability and coordination of the upper limbs, mainly including task-oriented movements with the goal to improve activities of daily living.
Both proximal and distal muscles are involved, in actions such as grasping wooden cubes of different sizes, pinching, reaching targets displayed in front of the patient, and doing patchwork or paper mandala.
|
|
Comparatore attivo: Passive motor treatment (PMT) group
15 people with multiple sclerosis performing a 8 week passive mobilization delivered by a physical therapist (3 sessions/week).
|
Passive mobilization delivered by a physical therapist of shoulder, elbow, wrist and fingers without detectable muscle activity.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in the time to perform the Nine Hole Peg Test (NHPT)
Lasso di tempo: Baseline and 8 weeks
|
The NHPT is a brief, standardized, quantitative test of upper extremity function, requiring participants to repeatedly place and then remove nine pegs into nine holes, one at a time, as quickly as possible.
|
Baseline and 8 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Score obtained at the Action Research Arm Test (ARAT)
Lasso di tempo: Baseline and 8 weeks
|
The Action Research Arm Test is an observational measure used to assess upper extremity performance (coordination, dexterity and functioning).
The scale ranges from 0 to 57, with higher scores indicating better outcomes.
Items are categorized into four subscales: grasp (score 0-18) , grip (0-12), pinch (0-18) and gross movement (0-9) which are arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task.
|
Baseline and 8 weeks
|
|
Grip and pinch strength
Lasso di tempo: Baseline and 8 weeks
|
Force applied by the hand and the fingers measured by means of specific dynamometers
|
Baseline and 8 weeks
|
|
Brain activity (blood-oxygenation-level dependent signal)
Lasso di tempo: Baseline and 8 weeks
|
Task-related brain activations assessed by means of functional magnetic resonance imaging during a finger-to-thumb opposition sequence
|
Baseline and 8 weeks
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Marco Bove, Prof, University of Genoa
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
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 (Effettivo)
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
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- FISM 2011R8
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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 Sclerosi multipla
-
Sanko UniversityCompletatoMULTIPLE SCLEROSIS | BILANCIO | VALIDITÀ | AFFIDABILITÀTurchia (Türkiye)