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

Completed

• Conditions: Stroke; Multiple Sclerosis; Parkinson Disease

• Registration Number: NCT04386863
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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 Timeline

• Study Start: 2018-06-22
• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-13
• Status Verified: 2022-06
• Primary Completion: 2022-07-07
• Study Completion: 2022-07-22
• Last Update Submitted: 2022-11-10
• Last Update Posted: 2022-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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.
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.
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.

Trial Locations

Locations (7)

AIAS di Milano Onlus; 🇮🇹 Milan, Italy

IRCCS San Camillo; 🇮🇹 Venice, Italy

Universita degli Studi di Genova; 🇮🇹 Genova, Italy

Ospedale San Carlo Borromeo; 🇮🇹 Milan, Italy

Università degli studi di Trieste; 🇮🇹 Trieste, Italy

Fondazione Don Gnocchi ONLUS; 🇮🇹 Milan, Italy

Ospedale San Giovanni Battista ACISMOM; 🇮🇹 Roma, Italy