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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04386863
• Other study ID #: Taxonomy
• Status: Completed
• Start date: June 22, 2018
• Est. completion date: July 22, 2022

Study information

• Verified date: June 2022
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: July 22, 2022
• Est. primary completion date: July 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Multiple Sclerosis
• Parkinson Disease
• Sclerosis
• Stroke

Locations

Country	Name	City	State
Italy	Universita degli Studi di Genova	Genova
Italy	AIAS di Milano Onlus	Milan
Italy	Fondazione Don Gnocchi ONLUS	Milan
Italy	Ospedale San Carlo Borromeo	Milan
Italy	Ospedale San Giovanni Battista ACISMOM	Roma
Italy	Università degli studi di Trieste	Trieste
Italy	IRCCS San Camillo	Venice

Sponsors (9)

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

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. Review. — View 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, Nilsagård Y, Dimitrova EN, Habek M, Armutlu K, Donzé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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