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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02306109 |
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Date of registration:
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21/11/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Motor Rehabilitation Treatment on Amyotrophic Lateral Sclerosis (ALS)
ermoSla |
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Scientific title:
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Effects of Motor Rehabilitation Treatment on Disability and Quality of Life in Amyotrophic Lateral Sclerosis (ALS). |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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65 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02306109 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Marco Vinceti, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Public Health Department, University of Modena and Reggio Emilia (IT) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Procedure: Standard motor rehabilitation treatment
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Procedure: Intensive motor rehabilitation treatment
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Primary Outcome(s)
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Change from Baseline in ALSFRS R
[Time Frame: 12 months]
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Secondary Outcome(s)
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Disease symptoms (fatigue) measured with FSS
[Time Frame: 12 months]
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Respiratory function: measured by FVC
[Time Frame: 12 months]
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Depression measured by Beck Inventory Scale
[Time Frame: 12 months]
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Perceived quality of care
[Time Frame: 12 months]
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Quality of Life: measured by McGill and ALSAQ40 scales
[Time Frame: 12 months]
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Rate of complications related to the disease: pressure sores, hospitalizations, infections
[Time Frame: 12 months]
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Time to supporting procedures (NIV and PEG)
[Time Frame: 12 months]
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Tracheostomy free survival
[Time Frame: 12 months]
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Secondary ID(s)
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AUSLMO_0001_SLA
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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