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

NCT04386863 | Completed

• 1 other identifier: Taxonomy
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 7

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

Conditions

Multiple Sclerosis; Stroke; Parkinson Disease

Keywords

Multiple Sclerosis; Stroke; Parkinson; Taxonomy; Rehabilitation; Outcome measures

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change in Reaching Performance Scale

  Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks

• Change in Activities-specific Balance Confidence scale

  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

  Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks

• Change in Manual Ability Measurement

  Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks

• Change in modified Dynamic Gait Index

  Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Diagnosis of Multiple Sclerosis
• Diagnosis of Parkinson Disease
• Diagnosis of Stroke
• Participants' rehabilitation program must include at least 10 sessions of physical therapy.

You may not qualify if:

• \- Unable to understand the aim of the study or unable to sign the informed consent form;

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• IRCCS San Camillo, Venezia, Italy: collaborator
• Universita degli Studi di Genova: collaborator
• AIAS di Milano Onlus: collaborator
• Ospedale San Carlo Borromeo: collaborator
• Azienda Universitaria Integrata Giuliano Isontina, Trieste, Italy: collaborator
• Presidio Ospedaliero San Camillo di Torino: collaborator
• Ospedali Riuniti Ancona: collaborator
• Istituto Don Orione, Pescara, Italy: collaborator

Study Sites (7)

Universita degli Studi di Genova

Genova, 16126, Italy

Location

Fondazione Don Gnocchi ONLUS

Milan, 20148, Italy

Location

Ospedale San Carlo Borromeo

Milan, 20153, Italy

Location

AIAS di Milano Onlus

Milan, 20156, Italy

Location

Ospedale San Giovanni Battista ACISMOM

Roma, 00148, Italy

Location

Università degli studi di Trieste

Trieste, 34127, Italy

Location

IRCCS San Camillo

Venice, 30126, Italy

Location

Related Publications (3)

• 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.

  PMID: 24370326 BACKGROUND

• 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.

  PMID: 27716390 BACKGROUND

• 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.

  PMID: 15083447 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Stroke; Parkinson Disease

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Davide Cattaneo, PhD

  Fondazione Don Carlo Gnocchi Onlus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: May 13, 2020
• Study Start: June 22, 2018
• Primary Completion: July 7, 2022
• Study Completion: July 22, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-06

Locations

IT (7)