Cognitive-motor Dual Task Training in Patients With Multiple Sclerosis

NCT04619953 | Completed DMC

• 1 other identifier: CE/PROG.812
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Balance Evaluation System Test (Mini-BESTest)

  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.

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

Secondary Outcomes (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

• 10 Meter Walk Test (10MWT)

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

• Inertial sensors-based assessment

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

• 2 Minute Walking Test (2MWT)

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

Study Arms (2)

Postural Stability group (PSg)

ACTIVE COMPARATOR

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

Other: Dynamic Postural Stability Training; Other: Conventional Therapy

Cognitive-Motor group (CMg)

ACTIVE COMPARATOR

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

Other: Cognitive-Motor Training; Other: Conventional Therapy

Interventions

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.

Postural Stability group (PSg)

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.

Cognitive-Motor group (CMg)

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

Cognitive-Motor group (CMg); Postural Stability group (PSg)

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead

Study Sites (1)

Marco Tramontano

Roma, 00179, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis; Cognitive Dysfunction; Motor Disorders

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Rehabilitation Services

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 6, 2020
• Study Start: November 9, 2020
• Primary Completion: May 1, 2022
• Study Completion: October 1, 2022
• Last Updated: July 13, 2023

Record last verified: 2023-07

Locations

IT (1)