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

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

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 *

• 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. Review.
• 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, Nilsagård Y, Dimitrova EN, Habek M, Armutlu K, Donzé C, Ross E, Ilie AM, Martić 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.
• 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.

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

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