Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
Effects of Motor Rehabilitation Treatment on Disability and Quality of Life in Amyotrophic Lateral Sclerosis (ALS).
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
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 randomly assigned to the Standard or Intensive treatment
(controlling for ALSFRSR rates at enrollment, age and site of onset). Randomization ratio is
1:1.
Standard treatment: 2 sessions/week of motor rehabilitation treatment (45 minutes each one)
for 10 weeks for a total of 20 sessions. The program consists of exercises for aerobic
endurance, reinforcement at low load and stretching. At the end of the 20 sessions patient
and caregiver are going to continue activity with supervision through regular follow up.
Intensive treatment is characterized by an increased volume of the above mentioned exercises:
5 sessions/week (45 minutes each one) for 10 weeks for a total of 50 sessions. At the end of
the 50 sessions patient and caregiver are going to continue activity with supervision through
regular follow up.
Collection and analysis of data
Recruitment: during the first 18 months of the study. Outcome measures: evaluated at
T0-T3-T6-T9-T12-T15-T18-T21-T24. Rating scales will be administered by a neurologist in singe
blind method with respect to the treatment.
Data collection will be done through an ad hoc Case Report Form and entered into a database
on a dedicated website.
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