Cognitive-motor Dual Task Training in Patients With Multiple Sclerosis

Neuropsychological Changes After 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).

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Cognitive Impairment; Motor Disorders
• Intervention / Treatment: Other: Dynamic Postural Stability Training; Other: Conventional Therapy; Other: Cognitive-Motor Training

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00179
    • Marco Tramontano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: 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.; 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
Active Comparator: Cognitive-Motor group (CMg); The Cognitive-Motor group (CMg) performed 30 minutes of conventional neuromotor rehabilitation and 20 minutes of cognitive-motor training.	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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Barthel Index (MBI)	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	Baseline, after 4 weeks of training, and 2 months after the end of training
Tinetti Balance and Gait Scale (TBG)	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	Baseline, after 4 weeks of training, and 2 months after the end of training
10 Meter Walk Test (10MWT)	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.	Baseline, after 4 weeks of training, and 2 months after the end of training
Inertial sensors-based assessment	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	Baseline, after 4 weeks of training, and 2 months after the end of training
2 Minute Walking Test (2MWT)	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	Baseline, after 4 weeks of training, and 2 months after the end of training
2 Minute Walking Test (2MWT) associated with Cognitive Task	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)	Baseline, after 4 weeks of training, and 2 months after the end of training

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Motor Disorders
• Other Study ID Numbers: CE/PROG.812

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No