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临床试验/NCT05462678
NCT05462678已完成不适用

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

I.R.C.C.S. Fondazione Santa Lucia2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Pre- and Post treatment and long term cognitive efficiency

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

Cognitive Rehabilitation

Experimental

the first group carried out a training of CR by three memory modules of the Rehacom program (http://www.emsmedical.net).

干预措施: Cognitive Rehabilitation (Behavioral)

Combined Training

Experimental

the second group followed a mixed training program with the use of the version of the verbal memory module of the Rehacom program combined with the MR training.

干预措施: Combined Rehabilitation (Behavioral)

Motor Rehabilitation

Experimental

the third group carried out a traditional MR training.

干预措施: Motor Rehabilitation (Behavioral)

结局指标

主要结局

Pre- and Post treatment and long term cognitive efficiency

时间窗: 9-months

The primary outcome of this study is the scores on the cognitive tasks (Minimal Assessment of Cognitive Functioning in Multiple Sclerosis -MACFIMS). For MACFIMS score ranges from 1 to 3 with higher scores corresponding to higher cognitive impairment.

次要结局

  • Pre- and Post-treatment and long term motor efficiency(9-months)

研究者

发起方
I.R.C.C.S. Fondazione Santa Lucia
申办方类型
Other
责任方
Sponsor

研究点 (2)

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