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Cognitive-motor Dual Task Training in Patients With Multiple Sclerosis

I

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

Status

Completed

Conditions

Cognitive Impairment
Motor Disorders
Multiple Sclerosis

Treatments

Other: Conventional Therapy
Other: Dynamic Postural Stability Training
Other: Cognitive-Motor Training

Study type

Interventional

Funder types

Other

Identifiers

NCT04619953
CE/PROG.812

Details and patient eligibility

About

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).

Enrollment

42 patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

42 participants in 2 patient groups

Postural Stability group (PSg)
Active Comparator group
Description:
The Postural Stability group (PSg) will perform 30 minutes of conventional neuromotor rehabilitation and 20 minutes of dynamic postural stability training.
Treatment:
Other: Dynamic Postural Stability Training
Other: Conventional Therapy
Cognitive-Motor group (CMg)
Active Comparator group
Description:
The Cognitive-Motor group (CMg) performed 30 minutes of conventional neuromotor rehabilitation and 20 minutes of cognitive-motor training.
Treatment:
Other: Cognitive-Motor Training
Other: Conventional Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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