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

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ClinicalTrials.gov Identifier: NCT04386863
Recruitment Status : Recruiting
First Posted : May 13, 2020
Last Update Posted : February 26, 2021
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

Tracking Information
First Submitted Date December 9, 2019
First Posted Date May 13, 2020
Last Update Posted Date February 26, 2021
Actual Study Start Date June 22, 2018
Estimated Primary Completion Date July 7, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 12, 2020)
  • 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
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 12, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Taxonomy of Neurorehabilitation Treatments and Outcome Measures: a Multicentre Italian Study
Official Title Taxonomy of Neurorehabilitation Treatments and Outcome Measures: a Multicentre Italian Study
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
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
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participants will be recruited in all the centers involved in the study, including both inpatients and outpatients.
Condition
  • Multiple Sclerosis
  • Stroke
  • Parkinson Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 12, 2020)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 22, 2022
Estimated Primary Completion Date July 7, 2022   (Final data collection date for primary outcome measure)
Eligibility 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;

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Davide Cattaneo, PhD +39-0240308814 dcattaneo@dongnocchi.it
Contact: Fabiola G Mestanza Mattos, MSc +390240308814 fmestanza@dongnocchi.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04386863
Other Study ID Numbers Taxonomy
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Davide Cattaneo, Fondazione Don Carlo Gnocchi Onlus
Study Sponsor Fondazione Don Carlo Gnocchi Onlus
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
Investigators
Principal Investigator: Davide Cattaneo, PhD Fondazione Don Carlo Gnocchi Onlus
PRS Account Fondazione Don Carlo Gnocchi Onlus
Verification Date February 2021