Status:
COMPLETED
Effect of Motor Rehabilitation Treatment on Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Azienda Unita' Sanitaria Locale Di Modena
Collaborating Sponsors:
University of Modena and Reggio Emilia
Azienda USL Reggio Emilia - IRCCS
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
ErmoSLA is a multicentric, randomized, controlled trial to compare effects of an "intensive" or "standard" motor rehabilitation treatment on motor disability in people with ALS
Detailed Description
The study is a multicentric, randomized, controlled trial to compare effects of standard versus intensive motor rehabilitation treatment for people with ALS. Eligible patients are going to be randoml...
Eligibility Criteria
Inclusion
- Diagnosis of possible, probable or definite ALS according to the Revised El Escorial Criteria
- Time from diagnosis \<18 months at screening.
- Forced vital capacity (FVC)\> 50% at screening
- Written informed consent
- Patients will be required to take the full dose of Riluzole, but not assuming Riluzole do not constitute a criterion for exclusion.
Exclusion
- Enrolment in any other clinical trial in the three months prior to screening
- Tracheostomy or NIV for\> 23h/day for 14 consecutive days at screening.
- Diagnosis of severe neurodegenerative diseases in addition to the ALS
- Diagnosis of severe heart disease, current neoplasia, any unstable medical condition that contraindicates an intensive rehabilitation treatment
- State of pregnancy or breastfeeding
- Residency outside Emilia-Romagna Region
- Lack of multidisciplinary follow-up
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT02306109
Start Date
January 1 2015
End Date
April 1 2018
Last Update
August 7 2018
Active Locations (3)
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1
Department of Neuroscience, S. Anna Hospital
Ferrara, Italy
2
Department of Neuroscience, S.Agostino-Estense Hospital
Modena, Italy
3
Department of Neuroscience, IRCCS Arcispedale Santa Maria Nuova
Reggio Emilia, Italy