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

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

Study Overview

• Status: Completed
• Conditions: Stroke; Multiple Sclerosis; 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

• Study Type: Observational
• Enrollment (Actual): 204

Contacts and Locations

Study Locations

• Italy
  • Genova, Italy, 16126
    • Università degli Studi di Genova
  • Milan, Italy, 20148
    • Fondazione Don Gnocchi ONLUS
  • Milan, Italy, 20153
    • Ospedale San Carlo Borromeo
  • Milan, Italy, 20156
    • AIAS di Milano Onlus
  • Roma, Italy, 00148
    • Ospedale San Giovanni Battista ACISMOM
  • Trieste, Italy, 34127
    • Università degli Studi di Trieste
  • Venice, Italy, 30126
    • IRCCS San Camillo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants will be recruited in all the centers involved in the study, including both inpatients and outpatients.

Description

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;

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Two minute walking test	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	Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks
Change in Box and Blocks test	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.	Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Reaching Performance Scale	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.	Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks
Change in Activities-specific Balance Confidence scale	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.	Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks
Change in Cognitive dual-task Timed-Up-and-Go test	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.	Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks
Change in Manual Ability Measurement	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.	Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks
Change in modified Dynamic Gait Index	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.	Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks
Modified Barthel Index	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.	Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus
• Collaborators: IRCCS San Camillo, Venezia, Italy; Universita degli Studi di Genova; Ospedale San Carlo Borromeo; Ospedali Riuniti Ancona; AIAS di Milano Onlus; Azienda Universitaria Integrata Giuliano Isontina, Trieste, Italy; Presidio Ospedaliero San Camillo di Torino; Istituto Don Orione, Pescara, Italy
• Investigators: Principal Investigator: Davide Cattaneo, PhD, Fondazione Don Carlo Gnocchi Onlus

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2018
• Primary Completion (Actual): July 7, 2022
• Study Completion (Actual): July 22, 2022

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Multiple Sclerosis; Stroke; Parkinson; Outcome measures; Taxonomy
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Multiple Sclerosis; Sclerosis; Parkinson Disease
• Other Study ID Numbers: Taxonomy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No