Amyotrophic Lateral Sclerosis
Conditions
Keywords
Motor Rehabilitation Treatment, Intensive versus standard, Motor Disability
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 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.
Interventions
PROCEDUREStandard 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
PROCEDUREIntensive 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
Sponsors
University of Modena and Reggio Emilia
Azienda USL Reggio Emilia - IRCCS
S. Anna Hospital
Azienda Unità Sanitaria Locale Ferrara
Azienda Unita' Sanitaria Locale Di Modena
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in ALSFRS R | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Perceived quality of care | 12 months |
| Tracheostomy free survival | 12 months |
| Time to supporting procedures (NIV and PEG) | 12 months |
| Rate of complications related to the disease: pressure sores, hospitalizations, infections | 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 |
| Respiratory function: measured by FVC | 12 months |
Countries
Italy
Outcome results
None listed