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Memory Rehabilitation Strategies in Patients With Multiple Sclerosis

NCT05462678 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-07-18

No results posted yet for this study

Summary

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).

Conditions

Interventions

BEHAVIORAL

Cognitive Rehabilitation

Each patient performed two weekly sessions of 45 minutes each, for 12 weeks

BEHAVIORAL

Combined Rehabilitation

Each patient performed one session per week (45 minutes) of CR and one session per week of traditional MR training for 12 weeks.

BEHAVIORAL

Motor Rehabilitation

Each patient performed two weekly sessions45 minutes each, for a total of 12 weeks.

Sponsors & Collaborators

  • I.R.C.C.S. Fondazione Santa Lucia

    lead OTHER

Principal Investigators

  • Ugo Nocentini, MD · I.R.C.C.S. "Santa Lucia" Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2021-04-20
Completion
2021-11-20

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05462678 on ClinicalTrials.gov