Cognitive-motor Dual Task Training in Patients With Multiple Sclerosis

Not Applicable

Completed

• Conditions: Cognitive Impairment; Multiple Sclerosis; Motor Disorders

• Registration Number: NCT04619953
• Lead Sponsor: I.R.C.C.S. Fondazione Santa Lucia

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-28
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-06
• Study Start: 2020-11-09
• Primary Completion: 2022-05-01
• Study Completion: 2022-10-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Balance Evaluation System Test (Mini-BESTest)	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 Outcome Measures

Name	Time	Method
Modified Barthel Index (MBI)	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
Tinetti Balance and Gait Scale (TBG)	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
10 Meter Walk Test (10MWT)	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.
Inertial sensors-based assessment	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
2 Minute Walking Test (2MWT)	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
2 Minute Walking Test (2MWT) associated with Cognitive Task	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)

Trial Locations

Locations (1)

Marco Tramontano; 🇮🇹 Roma, Italy