To Assess the Prevalence of Spasticity and the Impact on the Quality of Life in Multiple Sclerosis Patients
Observational Study to Assess the Prevalence of Spasticity and the Impact on the Quality of Life in Patients With Multiple Sclerosis in Argentina
This study is observational, non-controlled, multicentric and prospective, without experimental intervention or control. As part of the usual management of the subjects, scales will be used for the assessment of the spasticity and the quality of life (QoL).
The purpose of this observational study is to assess the incidence of spasticity in a group of subjects with Relapsing Remitting Multiple Sclerosis (RRMS) in Argentina and the way it affects the QoL of these subjects.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
One of most frequently observed symptoms in subjects with MS is spasticity. Spasticity is defined as an abnormal velocity-dependent increase in muscle tonic stretch reflexes due to an amplified reactivity of motor segments to sensory input. It is part of one of the components of the superior motoneurone syndrome and it may cause muscle rigidity and disability.
The spasticity, which could be measured in electrophysiological, biomechanical and clinical terms, has a significant prevalence. It is a frequent cause for consultation among subjects with MS and, consequently, has a significant impact on the QoL. Men and those subjects with MS of longer duration are the most affected by spasticity.
The aim of this study is to assess the impact that spasticity has on the QoL of subjects with MS.
The total duration of the study is 24 months. The recruiting period will be 12 months. Once the recruiting time is over, the collection of data will continue during the full 24 months period that was planned.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Rosario, Argentinien
- Fundacion Rosarina de Neurorehabilitacion
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Subjects aged from 21 60 years of age
- Subjects with established diagnosis of RRMS according to the revised McDonald criteria - 2005
- Subjects with a diagnosis of RRMS for more than one year
- The subject who have signed the Informed Consent
Exclusion Criteria:
- Subjects with other causes of spasticity
- Subjects with other clinical forms of MS (different from relapsing-remitting)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Assess the prevalence of spasticity in subjects with RRMS
Zeitfenster: Initial visit (Day 0) to 24 months
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Ashworth Scale (AS) (Spasticity) Expanded Disability status scale (EDSS) SF 36
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Initial visit (Day 0) to 24 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Evaluation of the impact of spasticity on the quality of life of subjects with RRMS
Zeitfenster: Initial visit (Day 0) to 24 months
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Initial visit (Day 0) to 24 months
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Evaluation of the changes in spasticity after 24 months
Zeitfenster: Initial visit (Day 0) to 24 months
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Initial visit (Day 0) to 24 months
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Dr. Jose A. Brizuela, Fundación Rosarina de Neurorehabilitación. Rosario, Argentina.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
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
- EMR200077-507
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