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Trial record 66 of 521 for:    ALS (Amyotrophic Lateral Sclerosis)

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 21, 2014
First Posted Date  ICMJE December 3, 2014
Last Update Posted Date August 7, 2018
Actual Study Start Date  ICMJE January 2015
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2014)
Change from Baseline in ALSFRS R [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02306109 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2014)
  • Rate of complications related to the disease: pressure sores, hospitalizations, infections [ Time Frame: 12 months ]
  • Perceived quality of care [ Time Frame: 12 months ]
  • Tracheostomy free survival [ Time Frame: 12 months ]
  • Time to supporting procedures (NIV and PEG) [ Time Frame: 12 months ]
  • Respiratory function: measured by FVC [ Time Frame: 12 months ]
  • Quality of Life: measured by McGill and ALSAQ40 scales [ Time Frame: 12 months ]
  • Disease symptoms (fatigue) measured with FSS [ Time Frame: 12 months ]
  • Depression measured by Beck Inventory Scale [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Motor Rehabilitation Treatment on Amyotrophic Lateral Sclerosis (ALS)
Official Title  ICMJE Effects of Motor Rehabilitation Treatment on Disability and Quality of Life in Amyotrophic Lateral Sclerosis (ALS).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Standard motor rehabilitation treatment
    Intervention: Procedure: Standard motor rehabilitation treatment
  • Experimental: Intensive motor rehabilitation treatment
    Intervention: Procedure: Intensive motor rehabilitation treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2018)
65
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2014)
80
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02306109
Other Study ID Numbers  ICMJE AUSLMO_0001_SLA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jessica Mandrioli, Azienda Unita' Sanitaria Locale Di Modena
Study Sponsor  ICMJE Azienda Unita' Sanitaria Locale Di Modena
Collaborators  ICMJE
  • 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  ICMJE
Study Chair: Marco Vinceti, MD Public Health Department, University of Modena and Reggio Emilia (IT)
PRS Account Azienda Unita' Sanitaria Locale Di Modena
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP