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

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ClinicalTrials.gov Identifier: NCT02306109
Recruitment Status : Completed
First Posted : December 3, 2014
Last Update Posted : August 7, 2018
Sponsor:
Collaborators:
University of Modena and Reggio Emilia
Arcispedale Santa Maria Nuova-IRCCS
S. Anna Hospital
Azienda Unità Sanitaria Locale Reggio Emilia
Azienda Unità Sanitaria Locale Ferrara
Information provided by (Responsible Party):
Jessica Mandrioli, Azienda Unita' Sanitaria Locale Di Modena

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

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Procedure: Standard motor rehabilitation treatment Procedure: Intensive motor rehabilitation treatment Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Motor Rehabilitation Treatment on Disability and Quality of Life in Amyotrophic Lateral Sclerosis (ALS).
Actual Study Start Date : January 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : April 2018


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




Primary Outcome Measures :
  1. Change from Baseline in ALSFRS R [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Rate of complications related to the disease: pressure sores, hospitalizations, infections [ Time Frame: 12 months ]
  2. Perceived quality of care [ Time Frame: 12 months ]
  3. Tracheostomy free survival [ Time Frame: 12 months ]
  4. Time to supporting procedures (NIV and PEG) [ Time Frame: 12 months ]
  5. Respiratory function: measured by FVC [ Time Frame: 12 months ]
  6. Quality of Life: measured by McGill and ALSAQ40 scales [ Time Frame: 12 months ]
  7. Disease symptoms (fatigue) measured with FSS [ Time Frame: 12 months ]
  8. Depression measured by Beck Inventory Scale [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02306109


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

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Responsible Party: Jessica Mandrioli, MD, Department of Neuroscience, St. Agostino-Estense Hospital, Modena (IT), Azienda Unita' Sanitaria Locale Di Modena
ClinicalTrials.gov Identifier: NCT02306109     History of Changes
Other Study ID Numbers: AUSLMO_0001_SLA
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018

Keywords provided by Jessica Mandrioli, Azienda Unita' Sanitaria Locale Di Modena:
Motor Rehabilitation Treatment
Intensive versus standard
Motor Disability

Additional relevant MeSH terms:
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Sclerosis
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases