Reup
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Experimental
Compared with
- Active Comparator #1
Placebo or sham
- Placebo
What it measured
Main measures
The Primary endpoint is the improvement in the distal motility of the upper limb evaluated with the Nine Hole Peg test.
baseline and after 2 and 5 months
Arm and hand function
Other measures (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
Arm and hand function
Who could take part
Progressive MS · 25 to 65
Inclusion criteria: * 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. Exclusion criteria: * history of a cardiovascular disorder or any other disease that can hamper the active participation to the research project. * Contraindication to perform MRI exams
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Jun 2021
Main results due
Nov 2024
Finished
Nov 2024
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