Clinical trial NCT02306109: Effect of Motor Rehabilitation Treatment on Amyotrophic Lateral Sclerosis (ALS)
Official title: Effects of Motor Rehabilitation Treatment on Disability and Quality of Life in Amyotrophic Lateral Sclerosis (ALS).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Motor Rehabilitation Treatment
Intensive versus standard
Motor Disability
Lead sponsor: Azienda Unita' Sanitaria Locale Di Modena
Sponsor class: OTHER
Collaborators: name: University of Modena and Reggio Emilia
name: Azienda USL Reggio Emilia - IRCCS
name: S. Anna Hospital
name: Azienda Unità Sanitaria Locale Ferrara
First posted: 2014-12-03
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in ALSFRS R
timeFrame: 12 months
Secondary outcomes:
measure: Rate of complications related to the disease: pressure sores, hospitalizations, infections
timeFrame: 12 months
measure: Perceived quality of care
timeFrame: 12 months
measure: Tracheostomy free survival
timeFrame: 12 months
measure: Time to supporting procedures (NIV and PEG)
timeFrame: 12 months
measure: Respiratory function: measured by FVC
timeFrame: 12 months
measure: Quality of Life: measured by McGill and ALSAQ40 scales
timeFrame: 12 months
measure: Disease symptoms (fatigue) measured with FSS
timeFrame: 12 months
measure: Depression measured by Beck Inventory Scale
timeFrame: 12 months
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Department of Neuroscience, S. Anna Hospital
city: Modena
country: Italy
facility: Department of Neuroscience, S.Agostino-Estense Hospital
city: Reggio Emilia
country: Italy
facility: Department of Neuroscience, IRCCS Arcispedale Santa Maria Nuova
Study officials:
affiliation: Public Health Department, University of Modena and Reggio Emilia (IT)
name: Marco Vinceti, MD
role: STUDY_CHAIR
References: