NCT02306109

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

2.9 years

First QC Date

November 21, 2014

Last Update Submit

August 5, 2018

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Motor Rehabilitation TreatmentIntensive versus standardMotor Disability

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in ALSFRS R

    12 months

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Standard motor rehabilitation treatment

ACTIVE COMPARATOR
Procedure: Standard motor rehabilitation treatment

Intensive motor rehabilitation treatment

EXPERIMENTAL
Procedure: Intensive motor rehabilitation treatment

Interventions

Standard motor rehabilitation treatmentPROCEDURE

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

Standard motor rehabilitation treatment
Intensive motor rehabilitation treatmentPROCEDURE

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

Intensive motor rehabilitation treatment

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Neuroscience, S. Anna Hospital

Ferrara, Italy

Location

Department of Neuroscience, S.Agostino-Estense Hospital

Modena, Italy

Location

Department of Neuroscience, IRCCS Arcispedale Santa Maria Nuova

Reggio Emilia, Italy

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Marco Vinceti, MD

    Public Health Department, University of Modena and Reggio Emilia (IT)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Department of Neuroscience, St. Agostino-Estense Hospital, Modena (IT)

Study Record Dates

First Submitted

November 21, 2014

First Posted

December 3, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2017

Study Completion

April 1, 2018

Last Updated

August 7, 2018

Record last verified: 2018-08

Locations

IT(3)