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Completed

NCT Number: NCT04619953

Cognitive-motor Dual Task Training in Patients With Multiple Sclerosis

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).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Cognition Disorders Cognitive Dysfunction Cognitive Impairment Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Mental Disorders Motor Disorders Nervous System Diseases Neurocognitive Disorders

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marco Tramontano

Roma, 00179, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dynamic Postural Stability Training

Other

The dynamic postural stability training, will consist of marching on unstable surface and on treadmill both with open and with closed eyes.

Cognitive-motor training

Other

The cognitive-motor training consisted of a dual task paradigm: each patient was asked to walk without stopping and was explained that, during the task, they might hear a sound, and in that case, they should have look at the stimulus 'side and recognize a visual target. This dual task was performed both marching on an unstable surface and marching on treadmill.

Conventional Therapy

Other

The conventional neuromotor rehabilitation will consist in muscles stretching, active-assisted mobilizations, neuromuscular facilitations, gait training and balance exercises using swinging platforms

Primary outcomes

  1. Balance Evaluation System Test (Mini-BESTest)

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

    Change of MiniBestTest (MBT) from baseline at 4 weeks of the training and at 60 days after the end of the training. The Mini-BESTest values ranging from 0 to 28, where 0 means the worse outcome and 28 the best one.

Secondary outcomes

  1. Modified Barthel Index (MBI)

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

    Change of Modified Barthel Index (MBI) from baseline at 4 weeks of the training and at 60 days after the end of the training. MBI values ranging from 0 to 105, where 0 means the worse outcome and 105 the best one

  2. Tinetti Balance and Gait Scale (TBG)

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

    Change of Tinetti Balance and Gait Scale (TBG) from baseline at 4 weeks of the training and at 60 days after the end of the training. TBG values ranging from 0 to 28, where 0 means the worse outcome and 28 the best one

  3. 10 Meter Walk Test (10MWT)

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

    Change of 10 Meter Walk Test (10MWT) from baseline at 4 weeks of the training and at 60 days after the end of the training. 10MWT allows to evaluate the walking speed.

  4. Inertial sensors-based assessment

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

    Set of seven magneto-inertial sensors (Opal, APDM Inc., Portland, Oregon, USA) will be used during the execution of walking motor tasks.

    Changes of continuous accelerometer signals will be recorded from baseline at 4 weeks of the training and at 60 days after the end of the training

  5. 2 Minute Walking Test (2MWT)

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

    Change of 2 Minute Walking Test (2MWT) from baseline at 4 weeks of the training and at 60 days after the end of the training. 2MWT allows to evaluate the endurance assessing the walking distance over two minutes

  6. 2 Minute Walking Test (2MWT) associated with Cognitive Task

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

    Change of 2 Minute Walking Test (2MWT) associated with Cognitive Task from baseline at 4 weeks of the training and at 60 days after the end of the training. 2MWT associated with Cognitive Task allows to evaluate the endurance assessing the walking distance over two minutes during a cognitive task execution (ex: verbalize the the highest number of animals'names during walking)

Sponsors and collaborators

Lead sponsor

I.R.C.C.S. Fondazione Santa Lucia

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 6, 2020
Registry last updated
Jul 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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