Cognitive-motor Dual Task Training in Patients With Multiple Sclerosis

NCT ID: NCT04619953

Last Updated: 2023-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-09
• Study Completion Date: 2022-10-01

Brief Summary

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).

Conditions

Multiple Sclerosis; Cognitive Impairment; Motor Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Postural Stability group (PSg)

The Postural Stability group (PSg) will perform 30 minutes of conventional neuromotor rehabilitation and 20 minutes of dynamic postural stability training.

Group Type: ACTIVE_COMPARATOR

Dynamic Postural Stability Training

Intervention Type: OTHER

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

Conventional Therapy

Intervention Type: OTHER

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

Cognitive-Motor group (CMg)

The Cognitive-Motor group (CMg) performed 30 minutes of conventional neuromotor rehabilitation and 20 minutes of cognitive-motor training.

Group Type: ACTIVE_COMPARATOR

Cognitive-Motor Training

Intervention Type: 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

Intervention Type: OTHER

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

Interventions

Dynamic Postural Stability Training

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

Intervention Type: OTHER

Cognitive-Motor Training

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.

Intervention Type: OTHER

Conventional Therapy

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Marco Tramontano

Head of Rehabilitation Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Marco Tramontano

Roma, , Italy

Countries

Italy

Other Identifiers

CE/PROG.812

Identifier Type: -

Identifier Source: org_study_id