Neuropsychological Changes After Cognitive-motor Dual Task Training in Patients With Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT04619953

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

  • Dynamic Postural Stability Training
  • Cognitive-Motor Training
  • Conventional Therapy

What it measured

Main measures

  • Balance Evaluation System Test (Mini-BESTest)

    Baseline, after 4 weeks of training, and 2 months after the end of training

    Walking and mobility

Other measures (6)

  • Modified Barthel Index (MBI)

    Baseline, after 4 weeks of training, and 2 months after the end of training

  • Tinetti Balance and Gait Scale (TBG)

    Baseline, after 4 weeks of training, and 2 months after the end of training

    Walking and mobility
  • 10 Meter Walk Test (10MWT)

    Baseline, after 4 weeks of training, and 2 months after the end of training

    Walking and mobility
  • Inertial sensors-based assessment

    Baseline, after 4 weeks of training, and 2 months after the end of training

    Walking and mobility
  • 2 Minute Walking Test (2MWT)

    Baseline, after 4 weeks of training, and 2 months after the end of training

    Walking and mobility
  • 2 Minute Walking Test (2MWT) associated with Cognitive Task

    Baseline, after 4 weeks of training, and 2 months after the end of training

    Thinking and memoryWalking and mobility

Who could take part

MS (type not specified) · 30 to 65 · EDSS 0 to 6

Show the full criteria

Inclusion criteria

* Diagnosis of MS according with revisited McDonalds criteria; * Expanded Disability Status Scale (EDSS) ranging between 0 and 6; * Ability to walk independently or with aid for at least 50 meters.

Exclusion criteria

* Associated psychiatric and/or neurological disorders (different from the MS); * Clinical relapse within the three months prior to enrollment; * Steroid therapy within 30 days before the enrollment; * Peripheric diseases as visual and/or auditory impairments that could interfere with motor and cognitive tasks execution; * Fracture of lower limb within three months before the enrollment.

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

About this trial

In the sponsor's words

Clinical features of Multiple Sclerosis (MS) vary widely from patient to other. About the 60% of patients with MS presents cognitive deficits associated with motor disability. The principal consequences of the motor disabilities concern difficult in gait and balance. The principal cognitive deficits concern the speed in elaborating information, the complex attention and the memory. During walking in daily life, it is often required to turn the head for looking something happening in the surrounding environment, for example when a sudden noise is heard, while crossing the street, when there's something interesting around or when is required to verbally answer to someone without stopping walking. All these examples are referred to a common daily life mechanism that has been defined as dual task (DT). Considering that the attention is a limited function, divide it in two different and simultaneous tasks (motor and cognitive), cause a cognitive-motor interference (CMI) that lead to a loss of efficacy in one or in both the tasks. The main aim of the study is to verify the impact of a brief rehabilitation training that combining motor and cognitive therapy using a dual-task paradigm, on balance and gait in MS patients, compared with the traditional therapies that provide a specific postural stability rehabilitation approach. Recruited patients will be randomized in two different groups which perform two different training. Each group perform the allocated training 3 times a week for 4 weeks. All the patients will be evaluated at the baseline (T0), at the end of the training (T1) and 60 days after the end of the training (T2).

Papers

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History

    1. Started

      Nov 2020

    2. Main results due

      May 2022

    3. Finished

      Oct 2022

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