Clinical trial NCT04386863: Taxonomy of Neurorehabilitation Treatments and Outcome Measures: a Multicentre Italian Study
Official title: Taxonomy of Neurorehabilitation Treatments and Outcome Measures: a Multicentre Italian Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Stroke
Parkinson Disease
Keywords: Multiple Sclerosis
Stroke
Parkinson
Taxonomy
Rehabilitation
Outcome measures
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: IRCCS San Camillo, Venezia, Italy
name: Universita degli Studi di Genova
name: AIAS di Milano Onlus
name: Ospedale San Carlo Borromeo
name: Azienda Universitaria Integrata Giuliano Isontina, Trieste, Italy
name: Presidio Ospedaliero San Camillo di Torino
name: Ospedali Riuniti Ancona
name: Istituto Don Orione, Pescara, Italy
First posted: 2020-05-13
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited in all the centers involved in the study, including both inpatients and outpatients.

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

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;

Primary outcomes:
measure: Change in Two minute walking test
timeFrame: Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks
measure: Change in Box and Blocks test
timeFrame: Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks
Secondary outcomes:
measure: Change in Reaching Performance Scale
timeFrame: Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks
measure: Change in Activities-specific Balance Confidence scale
timeFrame: Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks
measure: Change in Cognitive dual-task Timed-Up-and-Go test
timeFrame: Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks
measure: Change in Manual Ability Measurement
timeFrame: Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks
measure: Change in modified Dynamic Gait Index
timeFrame: Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks
measure: Modified Barthel Index
timeFrame: Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Universita degli Studi di Genova
city: Milan
country: Italy
facility: Fondazione Don Gnocchi ONLUS
city: Milan
country: Italy
facility: Ospedale San Carlo Borromeo
city: Milan
country: Italy
facility: AIAS di Milano Onlus
city: Roma
country: Italy
facility: Ospedale San Giovanni Battista ACISMOM
city: Trieste
country: Italy
facility: Università degli studi di Trieste
city: Venice
country: Italy
facility: IRCCS San Camillo
Study officials:
affiliation: Fondazione Don Carlo Gnocchi Onlus
name: Davide Cattaneo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dijkers MP, Hart T, Tsaousides T, Whyte J, Zanca JM. Treatment taxonomy for rehabilitation: past, present, and prospects. Arch Phys Med Rehabil. 2014 Jan;95(1 Suppl):S6-16. doi: 10.1016/j.apmr.2013.03.032.
citation: Rasova K, Freeman J, Martinkova P, Pavlikova M, Cattaneo D, Jonsdottir J, Henze T, Baert I, Van Asch P, Santoyo C, Smedal T, Beiske AG, Stachowiak M, Kovalewski M, Nedeljkovic U, Bakalidou D, Guerreiro JM, Nilsagard Y, Dimitrova EN, Habek M, Armutlu K, Donze C, Ross E, Ilie AM, Martic A, Romberg A, Feys P. The organisation of physiotherapy for people with multiple sclerosis across Europe: a multicentre questionnaire survey. BMC Health Serv Res. 2016 Oct 6;16(1):552. doi: 10.1186/s12913-016-1750-6.
citation: Dejong G, Horn SD, Gassaway JA, Slavin MD, Dijkers MP. Toward a taxonomy of rehabilitation interventions: Using an inductive approach to examine the "black box" of rehabilitation. Arch Phys Med Rehabil. 2004 Apr;85(4):678-86. doi: 10.1016/j.apmr.2003.06.033.