Effect of Motor Rehabilitation Treatment on Amyotrophic Lateral Sclerosis (ALS)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Motor Rehabilitation Treatment on Disability and Quality of Life in Amyotrophic Lateral Sclerosis (ALS).

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Procedure: Standard motor rehabilitation treatment
* Procedure: Intensive motor rehabilitation treatment


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard motor rehabilitation treatment<br> | Procedure: Standard motor rehabilitation treatment<br>* Standard treatment: 2 sessions/week of motor rehabilitation treatment (45 minutes each one) for 10 weeks for a total of 20 sessions, including exercises for aerobic endurance, reinforcement at low load and stretching. At the end of the 20 sessions, patient and caregiver are going to continue motor activity with therapist supervision through regular follow up<br>|
| Experimental: Intensive motor rehabilitation treatment<br> | Procedure: Intensive motor rehabilitation treatment<br>* Intensive treatment is characterized by an increased exercises volume: 5 sessions/week)(45 minutes each one) for 10 weeks for a total of 50 sessions, including exercises for aerobic endurance, reinforcement at low load and stretching. At the end of the 50 sessions, patient and caregiver are going to continue motor activity with therapist supervision through regular follow up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in ALSFRS R |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complications related to the disease: pressure sores, hospitalizations, infections |  | 12 months | 
| Perceived quality of care |  | 12 months | 
| Tracheostomy free survival |  | 12 months | 
| Time to supporting procedures (NIV and PEG) |  | 12 months | 
| Respiratory function: measured by FVC |  | 12 months | 
| Quality of Life: measured by McGill and ALSAQ40 scales |  | 12 months | 
| Disease symptoms (fatigue) measured with FSS |  | 12 months | 
| Depression measured by Beck Inventory Scale |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motor Rehabilitation Treatment, Intensive versus standard, Motor Disability