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
|Condition or disease|
|Multiple Sclerosis Stroke Parkinson Disease|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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|
- 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.
- 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.
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
|Contact: Davide Cattaneo, PhDfirstname.lastname@example.org|
|Contact: Fabiola G Mestanza Mattos, MScemail@example.com|
|Universita degli Studi di Genova||Recruiting|
|Genova, Italy, 16126|
|Contact: Elisa Pelosin firstname.lastname@example.org|
|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 email@example.com|
|Ospedale San Giovanni Battista ACISMOM||Not yet recruiting|
|Roma, Italy, 00148|
|Contact: Franca Tirinelli firstname.lastname@example.org|
|Università degli studi di Trieste||Recruiting|
|Trieste, Italy, 34127|
|Contact: Susanna Mezzarobba email@example.com|
|IRCCS San Camillo||Recruiting|
|Venice, Italy, 30126|
|Contact: Michela Agostini firstname.lastname@example.org|
|Principal Investigator:||Davide Cattaneo, PhD||Fondazione Don Carlo Gnocchi Onlus|