Effect of Motor Rehabilitation Treatment on Amyotrophic L... | NCT02306109

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

NCT02306109

Sponsor

Azienda Unita' Sanitaria Locale Di Modena

Status

Completed

Last Update Posted

Aug 7, 2018Actual

Enrollment

65Actual

Phase

Not Applicable

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Standard motor rehabilitation treatment
Intensive motor rehabilitation treatment

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015Actual

Primary Completion Date

Dec 2017Actual

Completion Date

Apr 2018Actual

First Submitted Date

Nov 21, 2014

First Submission Date that Met QC Criteria

Nov 30, 2014

First Posted Date

Dec 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2018

Last Update Posted Date

Aug 7, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jessica Mandrioli, MD, Department of Neuroscience, St. Agostino-Estense Hospital, Modena (IT), Azienda Unita' Sanitaria Locale Di ModenaPrincipal Investigator

Lead Sponsor

Azienda Unita' Sanitaria Locale Di ModenaOTHER

Collaborators

Name	Class
University of Modena and Reggio Emilia	OTHER
Azienda USL Reggio Emilia - IRCCS	OTHER_GOV
S. Anna Hospital	OTHER
Azienda Unità Sanitaria Locale Ferrara

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard motor rehabilitation treatment	Active Comparator		Procedure: Standard motor rehabilitation treatment
Intensive motor rehabilitation treatment	Experimental		Procedure: Intensive motor rehabilitation treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard motor rehabilitation treatment	Procedure	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Rate of complications related to the disease: pressure sores, hospitalizations, infections		12 months
Perceived quality of care		12 months
Tracheostomy free survival

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marco Vinceti, MD	Public Health Department, University of Modena and Reggio Emilia (IT)	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neuroscience, S. Anna Hospital		Ferrara			Italy
Department of Neuroscience, S.Agostino-Estense Hospital

Condition Browse Module

MeSH Terms

ID	Term
D000690	Amyotrophic Lateral Sclerosis

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D016472	Motor Neuron Disease

Browse Leaves

Not provided

Browse Branches

Not provided