Rehabilitative Protocols in Progressive Multiple Sclerosis Treated with Anti CD20 Monoclonal Antibodies

NCT06894940 | Completed Phase 2

• 1 other identifier: RF-2019-12370447
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Progressive multiple sclerosis (MS) patients have usually a worsening clinical course and it remains unclear if rehabilitation can indeed slow down the progression of the disease. Recently, clinical studies demonstrated that a treatment with monoclonal antibodies against B lymphocytes can have a positive effect on the progression of disability. Therefore now the investigators have, in this phase of the disease, a treatment that can impact the clinical course, even if the effect is not complete. The present study project has the aim to verify if, in progressive MS treated with monoclonal antibodies, a high technology rehabilitative protocol added to an intensive rehabilitation program is more effective on the motor recovery, in particular of the upper limb, as compared to an intensive traditional scheme of rehabilitation and to a passive treatment therapy, Moreover, the MRI functional reorganization of the central nervous system will be evaluated as well as the duration of the rehabilitative effect.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• The Primary endpoint is the improvement in the distal motility of the upper limb evaluated with the Nine Hole Peg test.

  It explores distal upper limb motility and is evaluated in seconds, with higher values corresponding to worse perfomance

  baseline and after 2 and 5 months

Secondary Outcomes (1)

• Patients will be evaluated at baseline, at the end of the treatment period and after 3 months with the the action research arm test (ARAT).

  at baseline, after 2 and 5 months

Study Arms (3)

Task oriented rehabilitation with virtual reality

EXPERIMENTAL

The intensive task oriented physiotherapy consists of focused single tasks (reaching a glass on the table) and occupational therapy on activities (tasks). The VR BTS NIRVANA system allows the patient to interact with virtual reality scenarios associated with daily activity tasks with increasing levels of complexity. NIRVANA is a system that projects on the wall or on the floor a large scenario where an interactive series of exercises is reproduced.In this project, the categories of exercise are 1.Sprites: patient is required to reach, touching or grabbing a series of objects. 2.Follow me: patient is required to control movement. 3.Motion: patient is required to focus on the quality of movement. 4.Hunt: patient is required to reach objects 5.Games: includes a list of effects that can be used by the therapist to define new personalized exercises.

Behavioral: Experimental

Task oriented rehabilitation

ACTIVE COMPARATOR

ntensive task oriented physiotherapy and occupational therapy of the upper limb, once every day, 3 hours a day for 4 weeks.

Behavioral: Active Comparator #1

Passive mobilization

PLACEBO COMPARATOR

The passive mobilization protocol consists of passive movements of the proximal and distal parts of the upper limbs

Behavioral: Placebo

Interventions

Active Comparator #1 BEHAVIORAL

task oriented rehabilitation

Also known as: task oriented rehabilitation

Task oriented rehabilitation

Placebo BEHAVIORAL

passive rehabilitation

Also known as: passive rehabilitation

Passive mobilization

Experimental BEHAVIORAL

rehabilitation with virtual reality

Also known as: rehabilitation with virtual reality

Task oriented rehabilitation with virtual reality

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 25-65 years;
• right-handed
• progressive active form of MS treated with anti B monoclonal antibodies, Ocrelizumab or Rituximab since at least 6 months.
• EDSS 3-7.
• absence of relevant cognitive deficiency, as evaluated with Brief International Cognitive Assessment for MS (Bicams) °absence of visual or audio deficit disorders.

You may not qualify if:

• history of a cardiovascular disorder or any other disease that can hamper the active participation to the research project.
• Contraindication to perform MRI exams

Sponsors & Collaborators

• University of Pavia: lead
• University of Genova: collaborator
• Consorzio per Valutazioni Biologiche e Farmacologiche: collaborator
• A.O.U. Città della Salute e della Scienza: collaborator

Study Sites (1)

ICS Salvatore Maugeri, Pavia

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• antonio nardone, prof

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 25, 2025
• Study Start: June 1, 2021
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)