An interventional study of Standard motor rehabilitation treatment and Intensive motor rehabilitation treatment in Amyotrophic Lateral Sclerosis, sponsored by Azienda Unita' Sanitaria Locale Di Modena. Completed at 3 sites in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-08-07.
Sponsored by Azienda Unita' Sanitaria Locale Di Modena · Not applicable, Interventional, and Treatment
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.
717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.
This study's enrollment of 65 is above the median of 35 across 461 interventional studies indexed under Motor Neuron Disease.
Browse Motor Neuron Disease studies →Azienda Unita' Sanitaria Locale Di Modena is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be required to take the full dose of Riluzole, but not assuming Riluzole do not constitute a criterion for exclusion.
Exclusion Criteria:
Procedure: Standard motor rehabilitation treatment
Procedure: Intensive 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
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
Change from Baseline in ALSFRS R
Time frame: 12 months
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
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Azienda Unita' Sanitaria Locale Di Modena