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

Azienda Unita' Sanitaria Locale Di Modena

Status

Completed

Conditions

Amyotrophic Lateral Sclerosis

Treatments

Procedure: Standard motor rehabilitation treatment

Procedure: Intensive motor rehabilitation treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT02306109

AUSLMO_0001_SLA

Details and patient eligibility

About

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

Full 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.

Enrollment

65 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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