AzTrials
AzTrials

Multiple SclerosisNCT04386863

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

An observational study of Multiple Sclerosis and Stroke, run by Fondazione Don Carlo Gnocchi ETS at 7 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis, Stroke, Parkinson Disease
How many people
204 participants
Where
7 sitesItaly
Study dates
22 Jun 2018to 22 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Italy7 sites

  • Universita degli Studi di Genova

    Genova, 16126

  • Fondazione Don Gnocchi ONLUS

    Milan, 20148

  • Ospedale San Carlo Borromeo

    Milan, 20153

  • AIAS di Milano Onlus

    Milan, 20156

  • Ospedale San Giovanni Battista ACISMOM

    Roma, 00148

  • Università degli studi di Trieste

    Trieste, 34127

  • IRCCS San Camillo

    Venice, 30126

Other trials in Italy

About this 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

Read the 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

Keywords
Multiple Sclerosis, Stroke, Parkinson, Taxonomy, Rehabilitation, Outcome measures
Medical subject headings
Multiple Sclerosis, Stroke, Parkinson Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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.

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

Secondary outcomes (6)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2020
  2. Study start22 Jun 2018
  3. Primary completion7 Jul 2022
  4. Study completion22 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04386863
Sponsor's protocol ID
Taxonomy
Status last verified
Jun 2022
First submitted
9 Dec 2019
Last updated
15 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 24370326

  • 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.

    PubMed 27716390

  • 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.

    PubMed 15083447

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis and Stroke, run by Fondazione Don Carlo Gnocchi ETS at 7 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Two minute walking test (time frame: Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04386863, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in