- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00424359
Ambulation Study in Multiple Sclerosis
A Prospective Study of Clinical Indices as Predictors of Ambulatory Effectiveness in Multiple Sclerosis
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
This study includes:
Three study visits to the MS Center at Evergreen; wearing a pedometer for two, one-week periods to record walking during regular daily activities; keeping a diary for any walking problems such as falls and slips.
Subjects must meet the following criteria:
Diagnosis of MS (any form); 18-70 years of age; be on stable MS treatment OR no MS treatment for the last three months; no scheduled hospitalization in the next six months.
Undersøgelsestype
Tilmelding (Forventet)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Subject must have sufficient cognitive ability to maintain a falls diary and follow instructions for wearing the pedometer
- Subject must have clinically definite MS according to McDonald criteria
- Subject must have EDSS between 0-6.5
- Subject must be aged 18-70
- Subjects must be given informed consent
- Subjects must be stable on disease modifying therapy or no therapy for at least three months before entry into study
Exclusion Criteria:
- No MS relapse within the last 30 days
- Subjects must have no scheduled major hospitalizations or surgical procedures during the study time frame. Hospitalization during the study may result in removal from the study
- Medical conditions other than MS that might significantly impact ambulatory activity (such as angina pectoris) in the judgement of the investigators
- History or suspicion of non-compliance in the judgement of the investigators
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Theodore R Brown, MD, MPH, MS Center at Evergreen
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- WIRB 20050607
- Pfizer Inc (Pfizer investigator initiated study)
- Independent Grants 235-14-22
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Kliniske forsøg med Multipel sclerose
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