Overview

This trial is active, not recruiting.

Condition amyotrophic lateral sclerosis
Treatments standard motor rehabilitation treatment, intensive motor rehabilitation treatment
Sponsor Azienda Unita' Sanitaria Locale Di Modena
Collaborator University of Modena and Reggio Emilia
Start date July 2013
End date July 2016
Trial size 67 participants
Trial identifier NCT02306109, AUSLMO_0001_SLA

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Active Comparator)
standard motor rehabilitation treatment
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
(Experimental)
intensive motor rehabilitation treatment
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

Primary Outcomes

Measure
Change from Baseline in ALSFRS R
time frame: 12 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Effects of Motor Rehabilitation Treatment on Disability and Quality of Life in Amyotrophic Lateral Sclerosis (ALS).
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Azienda Unita' Sanitaria Locale Di Modena.