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

Sponsor

Fondazione Don Carlo Gnocchi Onlus (Other)

Overall Status

Recruiting

CT.gov ID

NCT04386863

Collaborator

IRCCS San Camillo, Venezia, Italy (Other), Universita degli Studi di Genova (Other), AIAS di Milano Onlus (Other), Ospedale San Carlo Borromeo (Other), Università degli studi di Trieste (Other), Ospedale San Giovanni Battista ACISMOM (Other), Presidio Ospedaliero San Camillo di Torino (Other), Istituto di Riabilitazione Santo Stefano, Macerata, Italy (Other), Ospedali Riuniti Ancona (Other), Foligno Hospital (Other)

200

Enrollment

Locations

Anticipated Duration (Months)

28.6

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis Stroke 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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 22, 2018

Anticipated Primary Completion Date :

Jul 7, 2022

Anticipated Study Completion Date :

Jul 22, 2022

Outcome Measures

Primary Outcome Measures

Change in Two minute walking test [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 [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.

Secondary Outcome Measures

Change in Reaching Performance Scale [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Universita degli Studi di Genova	Genova	Italy	16126
2	Fondazione Don Gnocchi ONLUS	Milan	Italy	20148
3	Ospedale San Carlo Borromeo	Milan	Italy	20153
4	AIAS di Milano Onlus	Milan	Italy	20156
5	Ospedale San Giovanni Battista ACISMOM	Roma	Italy	00148
6	Università degli studi di Trieste	Trieste	Italy	34127
7	IRCCS San Camillo	Venice	Italy	30126