Strategies and Techniques for the Rehabilitation of Memory Deficits in Patients With Multiple Sclerosis

CompletedNot a drug-phase studyRelapsing and progressiveNCT05462678

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Cognitive Rehabilitation
  • Combined Rehabilitation
  • Motor Rehabilitation

What it measured

Main measures

  • Pre- and Post treatment and long term cognitive efficiency

    9-months

    Thinking and memory

Other measures (1)

  • Pre- and Post-treatment and long term motor efficiency

    9-months

    Walking and mobility

Who could take part

Relapsing and progressive · 18 to 65

Show the full criteria

Inclusion criteria

* Diagnosis of MS defined according to McDonald's diagnostic criteria revised in 2011. * RRMS or SPMS phenotype. * Language Italian mother tongue. * EDSS score \<6.0

Exclusion criteria

* Neurological or psychiatric pathologies other than MS that can interfere with cognitive functioning * Clinical relapses in the three months prior to enrollment * Severe mental illness * Psychiatric disorders severe enough to interfere with cognitive functioning * Medications Steroid therapy in the 3 months prior to enrollment * Motor limitations Upper limb dysfunction (paralysis or tremor) that does not allow to hold the PC mouse * Sensory limitations Visual acuity impaired enough to not allow reading of the instructions to the various tests

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The clinical characteristics of MS are extremely variable from one patient to another. In about 60% of cases, motor disabilities are associated with cognitive deficits. The present study aims to compare three forms of cognitive / motor rehabilitation in three groups of patients with MS: rehabilitation of verbal memory with the Rehacom program; combined rehabilitation, associating a motor rehabilitation path with the Rehacom program; only motor rehabilitation course. Aims of the study will be: to verify whether the combined cognitive / motor rehabilitation can induce a significantly greater improvement in the memory performance of patients with MS compared to rehabilitation alone; check whether any improvement is objectively verifiable by patients and the impact it may have on patients' quality of life; monitor these effects after 6 months. For these purposes, three homogeneous groups of 20 patients each will be enrolled, diagnosed with MS according to Mc Donald's criteria revisited by Polman (2011). The study will be divided into an initial clinical, cognitive, emotional, quality of life and functional self-perception (T0) assessment. Subsequently, the patients assigned to the three conditions will be provided with the pre-established rehabilitation treatments for a total duration of 12 weeks; at the end, each patient will undergo an overall re-evaluation (T1). Finally, a further overall reassessment will be carried out after 6 months, aimed at follow-up monitoring (T2). Statistical analyzes will be of two types: Within Group (aimed at assessing any improvement in the cognitive performance of each group of patients by comparing the assessments at T0 with those at T1 and T2); Between Group (aimed at comparing the results obtained by each group with those of the other 2 groups at T0, T1, and T2).

Papers

Loading reviews and guidelines…

History

    1. Started

      Sept 2018

    2. Main results due

      Apr 2021

    3. Finished

      Nov 2021

    Assembled by software from public sources.