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

Amyotrophic Lateral Sclerosis Clinical Trial

— ermoSla  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02306109
• Other study ID #: AUSLMO_0001_SLA
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: April 2018

Study information

• Verified date: August 2018
• Source: Azienda Unita' Sanitaria Locale Di Modena
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

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
• 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

Locations

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

Sponsors (6)

Lead Sponsor	Collaborator
Azienda Unita' Sanitaria Locale Di Modena	Arcispedale Santa Maria Nuova-IRCCS, Azienda Unità Sanitaria Locale Ferrara, Azienda Unità Sanitaria Locale Reggio Emilia, S. Anna Hospital, University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in ALSFRS R		12 months
Secondary	Rate of complications related to the disease: pressure sores, hospitalizations, infections		12 months
Secondary	Perceived quality of care		12 months
Secondary	Tracheostomy free survival		12 months
Secondary	Time to supporting procedures (NIV and PEG)		12 months
Secondary	Respiratory function: measured by FVC		12 months
Secondary	Quality of Life: measured by McGill and ALSAQ40 scales		12 months
Secondary	Disease symptoms (fatigue) measured with FSS		12 months
Secondary	Depression measured by Beck Inventory Scale		12 months