Amyotrophic Lateral SclerosisermoSlaNCT02306109
Effect of Motor Rehabilitation Treatment on Amyotrophic Lateral Sclerosis (ALS)
A study testing Standard motor rehabilitation treatment and Intensive motor rehabilitation treatment in people with Amyotrophic Lateral Sclerosis, run by Azienda Unita' Sanitaria Locale Di Modena at 3 sites in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Standard motor rehabilitation treatment and Intensive motor rehabilitation treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 3 sitesItaly
- Study dates
- Jan 2015to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Department of Neuroscience, S. Anna Hospital
Ferrara
Department of Neuroscience, S.Agostino-Estense Hospital
Modena
Department of Neuroscience, IRCCS Arcispedale Santa Maria Nuova
Reggio Emilia
About this study
Official title: Effects of Motor Rehabilitation Treatment on Disability and Quality of Life in Amyotrophic Lateral Sclerosis (ALS).
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
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Standard motor rehabilitation treatment, Intensive motor rehabilitation treatment
- Keywords
- Motor Rehabilitation Treatment, Intensive versus standard, Motor Disability
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard motor rehabilitation treatmentProcedure or surgery
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 treatmentProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Standard motor rehabilitation treatment | Active comparator | Not described Receives: Procedure: Standard motor rehabilitation treatment |
| Intensive motor rehabilitation treatment | Experimental | Not described Receives: Procedure: Intensive motor rehabilitation treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in ALSFRS R
Measured: 12 months
Secondary outcomes (8)
Rate of complications related to the disease: pressure sores, hospitalizations, infections
Measured: 12 months
Perceived quality of care
Measured: 12 months
Tracheostomy free survival
Measured: 12 months
Time to supporting procedures (NIV and PEG)
Measured: 12 months
Respiratory function: measured by FVC
Measured: 12 months
Quality of Life: measured by McGill and ALSAQ40 scales
Measured: 12 months
Disease symptoms (fatigue) measured with FSS
Measured: 12 months
Depression measured by Beck Inventory Scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Unita' Sanitaria Locale Di Modena
- Sponsor type
- University, hospital or other
- Collaborators
- University of Modena and Reggio Emilia, Azienda USL Reggio Emilia - IRCCS, S. Anna Hospital, Azienda Unità Sanitaria Locale Ferrara
- Responsible party
- Principal investigator, Jessica Mandrioli, Azienda Unita' Sanitaria Locale Di Modena
- Investigators
- Marco Vinceti, MD, Study chair, Public Health Department, University of Modena and Reggio Emilia (IT)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306109
- Sponsor's protocol ID
- AUSLMO_0001_SLA
- Acronym
- ermoSla
- Status last verified
- Aug 2018
- First submitted
- 21 Nov 2014
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Motor Rehabilitation Treatment on Disability and Quality of Life in Amyotrophic Lateral Sclerosis (ALS).
- ClinicalTrials.gov ID
- NCT02306109
- Acronym / sponsor ID
- ermoSla / AUSLMO_0001_SLA
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Motor Rehabilitation Treatment, Intensive versus standard, Motor Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Azienda Unita' Sanitaria Locale Di ModenaUniversity, hospital or other
- Collaborators
- University of Modena and Reggio Emilia, Azienda USL Reggio Emilia - IRCCS, S. Anna Hospital, Azienda Unità Sanitaria Locale Ferrara
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard motor rehabilitation treatment | Active comparator | Procedure: Standard motor rehabilitation treatment |
| Intensive motor rehabilitation treatment | Experimental | Procedure: Intensive motor rehabilitation treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard motor rehabilitation treatmentStandard 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 or surgery | Standard motor rehabilitation treatment |
| Intensive motor rehabilitation treatmentIntensive 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 | Procedure or surgery | Intensive motor rehabilitation treatment |
Primary outcome
Change from Baseline in ALSFRS R
Time frame: 12 months
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Vinceti, MD study chair
Public Health Department, University of Modena and Reggio Emilia (IT)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard motor rehabilitation treatment and Intensive motor rehabilitation treatment in people with Amyotrophic Lateral Sclerosis, run by Azienda Unita' Sanitaria Locale Di Modena at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in ALSFRS R (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.