- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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.
|
Aktiver Komparator: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in the time to perform the Nine Hole Peg Test (NHPT)
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Score obtained at the Action Research Arm Test (ARAT)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Marco Bove, Prof, University of Genoa
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- FISM 2011R8
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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