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

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

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

Study Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Procedure: Standard motor rehabilitation treatment; Procedure: Intensive motor rehabilitation treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Ferrara, Italy
    • Department of Neuroscience, S. Anna Hospital
  • Modena, Italy
    • Department of Neuroscience, S.Agostino-Estense Hospital
  • Reggio Emilia, Italy
    • Department of Neuroscience, IRCCS Arcispedale Santa Maria Nuova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard motor rehabilitation treatment	Procedure: 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	Procedure: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Azienda Unita' Sanitaria Locale Di Modena
• Collaborators: Azienda Unità Sanitaria Locale Reggio Emilia; University of Modena and Reggio Emilia; Arcispedale Santa Maria Nuova-IRCCS; S. Anna Hospital; Azienda Unità Sanitaria Locale Ferrara
• Investigators: Study Chair: Marco Vinceti, MD, Public Health Department, University of Modena and Reggio Emilia (IT)

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: November 21, 2014
• First Submitted That Met QC Criteria: November 30, 2014
• First Posted (Estimate): December 3, 2014

Study Record Updates

• Last Update Posted (Actual): August 7, 2018
• Last Update Submitted That Met QC Criteria: August 5, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Motor Rehabilitation Treatment; Intensive versus standard; Motor Disability
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: AUSLMO_0001_SLA