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Completed

NCT Number: NCT04386863

Taxonomy of Neurorehabilitation Treatments and Outcome Measures: a Multicentre Italian 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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Stroke Synucleinopathies Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universita degli Studi di Genova, Genova, Italy

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Primary outcomes

  1. Change in Two minute walking test

    Time frame: 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

  2. Change in Box and Blocks test

    Time frame: 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 outcomes

  1. Change in Reaching Performance Scale

    Time frame: 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.

  2. Change in Activities-specific Balance Confidence scale

    Time frame: 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.

  3. Change in Cognitive dual-task Timed-Up-and-Go test

    Time frame: 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.

  4. Change in Manual Ability Measurement

    Time frame: 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.

  5. Change in modified Dynamic Gait Index

    Time frame: 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.

  6. Modified Barthel Index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Collaborators

  • 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

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 13, 2020
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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