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Taxonomy of Neurorehabilitation Treatments and Outcome Measures: a Multicentre Italian Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04386863
Recruitment Status : Recruiting
First Posted : May 13, 2020
Last Update Posted : May 13, 2020
Sponsor:
Collaborators:
IRCCS San Camillo, Venezia, Italy
Universita degli Studi di Genova
AIAS di Milano Onlus
Ospedale San Carlo Borromeo
Università degli studi di Trieste
Ospedale San Giovanni Battista ACISMOM
Presidio Ospedaliero San Camillo di Torino
Istituto di Riabilitazione Santo Stefano, Macerata, Italy
Ospedali Riuniti Ancona
Foligno Hospital
Information provided by (Responsible Party):
Davide Cattaneo, Fondazione Don Carlo Gnocchi Onlus

Brief Summary:
The main aims of the observational study are to taxonomize the contents of rehabilitation understanding goals and treatments provided to people with Parkinson Disease(PD) and Multiple Sclerosis(MS) and Stroke and their impact on the outcomes

Condition or disease
Multiple Sclerosis Stroke Parkinson Disease

Detailed Description:
In recent years, neurological rehabilitation focused on evaluating patient's problems, with no rationalization of therapeutic interventions. Few researches investigated the contribution of the components of a neurorehabilitation program to the clinical outcome in everyday clinical practice. Moreover, there is no a standard method to categorize rehabilitative interventions, making difficult to explain why subjects improve and which of the various treatments is more effective. Thus, it was decided to build a multicentre network to collect data using a taxonomy tool developed to provide information on the goals of rehabilitation and to categorize rehabilitation interventions

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Taxonomy of Neurorehabilitation Treatments and Outcome Measures: a Multicentre Italian Study
Actual Study Start Date : June 22, 2018
Estimated Primary Completion Date : July 7, 2020
Estimated Study Completion Date : July 22, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in Two minute walking test [ Time Frame: Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks ]
    The Two minute walking test is a test used to evaluate functional exercise capacity. Subjects are instructed to walk as fast as possible in 2 minutes, along a 30-m hallway. Total distance walked is recorded

  2. Change in Box and Blocks test [ Time Frame: Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks ]
    The Box and Block Test measures unilateral gross manual dexterity. The test consists of a box with a partition in the middle and is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial.


Secondary Outcome Measures :
  1. Change in Reaching Performance Scale [ Time Frame: Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks ]
    The Reaching Performance Scale is a visual scale used in clinics to provide assessment of motor capabilities during reaching movements. It was designed to investigate reaching movements at low height in the workspace of the limb, at increasing distance. Higher scores indicate better performances.

  2. Change in Activities-specific Balance Confidence scale [ Time Frame: Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks ]
    The Activities-specific Balance Confidence scale asks individuals to self-report their balance confidence in successfully performing 16 specific movement activities of varied balance difficulty. Higher scores indicate better balance confidence.

  3. Change in Cognitive dual-task Timed-Up-and-Go test [ Time Frame: Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks ]
    Patients will be first asked to stand from a seated position, walk 3 m at their usual pace, turn around, walk back to the chair, and sit down (the Timed Up and Go test). Walking aids were allowed. After a recovery phase, patients will be asked to perform the same exercise while performing a cognitive dual task (continuously subtracting 2, starting from 100; the Cognitive dual-task Timed Up and Go test). Lower times indicate better performances.

  4. Change in Manual Ability Measurement [ Time Frame: Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks ]
    The Manual Ability Measurement is a questionnaire on perceived ease or difficulty that a persons may experience when performing unilateral and bilateral ADL tasks. Higher scores indicate less difficulty in ADL tasks.

  5. Change in modified Dynamic Gait Index [ Time Frame: Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks ]
    The modified Dynamic Gait Index is a clinical outcome measure to assess the ability to modify and adapt gait and balance during complex walking tasks. Higher scores indicate better performances.

  6. Modified Barthel Index [ Time Frame: Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks ]
    Measure of physical disability used widely to assess behaviour relating to activities of daily living for patients with disabling conditions. It measures what patients do in practice. Higher scores indicate low level of disability.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants will be recruited in all the centers involved in the study, including both inpatients and outpatients.
Criteria

Inclusion Criteria:

  • Diagnosis of Multiple Sclerosis
  • Diagnosis of Parkinson Disease
  • Diagnosis of Stroke
  • Participants' rehabilitation program must include at least 10 sessions of physical therapy.

Exclusion Criteria:

- Unable to understand the aim of the study or unable to sign the informed consent form;


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): NCT04386863


Contacts
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Contact: Davide Cattaneo, PhD +39-0240308814 dcattaneo@dongnocchi.it
Contact: Fabiola G Mestanza Mattos, MSc +390240308814 fmestanza@dongnocchi.it

Locations
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Italy
Universita degli Studi di Genova Recruiting
Genova, Italy, 16126
Contact: Elisa Pelosin       elisapelosin@yahoo.it   
Fondazione Don Gnocchi ONLUS Recruiting
Milan, Italy, 20148
Contact: Davide Cattaneo, PhD         
Principal Investigator: Davide Cattaneo, PhD         
Ospedale San Carlo Borromeo Recruiting
Milan, Italy, 20153
Contact: Rita Russo       Russo.Rita@sancarlo.mi.it   
AIAS di Milano Onlus Recruiting
Milan, Italy, 20156
Contact: Francesca Marazzini       marazzini@aiasmilano.it   
Ospedale San Giovanni Battista ACISMOM Not yet recruiting
Roma, Italy, 00148
Contact: Franca Tirinelli       franca1965@alice.it   
Università degli studi di Trieste Recruiting
Trieste, Italy, 34127
Contact: Susanna Mezzarobba       mezzarob@units.it   
IRCCS San Camillo Recruiting
Venice, Italy, 30126
Contact: Michela Agostini       michela.agostini@ospedalesancamillo.net   
Sponsors and Collaborators
Fondazione Don Carlo Gnocchi Onlus
IRCCS San Camillo, Venezia, Italy
Universita degli Studi di Genova
AIAS di Milano Onlus
Ospedale San Carlo Borromeo
Università degli studi di Trieste
Ospedale San Giovanni Battista ACISMOM
Presidio Ospedaliero San Camillo di Torino
Istituto di Riabilitazione Santo Stefano, Macerata, Italy
Ospedali Riuniti Ancona
Foligno Hospital
Investigators
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Principal Investigator: Davide Cattaneo, PhD Fondazione Don Carlo Gnocchi Onlus
Publications:
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Responsible Party: Davide Cattaneo, Principal Investigator, Fondazione Don Carlo Gnocchi Onlus
ClinicalTrials.gov Identifier: NCT04386863    
Other Study ID Numbers: Taxonomy
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Davide Cattaneo, Fondazione Don Carlo Gnocchi Onlus:
Multiple Sclerosis
Stroke
Parkinson
Taxonomy
Rehabilitation
Outcome measures
Additional relevant MeSH terms:
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Parkinson Disease
Multiple Sclerosis
Sclerosis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Neurodegenerative Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases