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Cognitive-motor Dual Task Training in Patients With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis, Cognitive Impairment, Motor Disorders

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Dynamic Postural Stability Training
Cognitive-Motor Training
Conventional Therapy
Sponsored by
I.R.C.C.S. Fondazione Santa Lucia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Marco Tramontano

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Postural Stability group (PSg)

Cognitive-Motor group (CMg)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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.
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
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
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)

Full Information

First Posted
October 28, 2020
Last Updated
July 12, 2023
Sponsor
I.R.C.C.S. Fondazione Santa Lucia
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1. Study Identification

Unique Protocol Identification Number
NCT04619953
Brief Title
Cognitive-motor Dual Task Training in Patients With Multiple Sclerosis
Official Title
Neuropsychological Changes After Cognitive-motor Dual Task Training in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I.R.C.C.S. Fondazione Santa Lucia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Cognitive Impairment, Motor Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Postural Stability group (PSg)
Arm Type
Active Comparator
Arm Description
The Postural Stability group (PSg) will perform 30 minutes of conventional neuromotor rehabilitation and 20 minutes of dynamic postural stability training.
Arm Title
Cognitive-Motor group (CMg)
Arm Type
Active Comparator
Arm Description
The Cognitive-Motor group (CMg) performed 30 minutes of conventional neuromotor rehabilitation and 20 minutes of cognitive-motor training.
Intervention Type
Other
Intervention Name(s)
Dynamic Postural Stability Training
Intervention Description
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
Intervention Name(s)
Cognitive-Motor Training
Intervention Description
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
Intervention Name(s)
Conventional Therapy
Intervention Description
The conventional neuromotor rehabilitation will consist in muscles stretching, active-assisted mobilizations, neuromuscular facilitations, gait training and balance exercises using swinging platforms
Primary Outcome Measure Information:
Title
Balance Evaluation System Test (Mini-BESTest)
Description
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.
Time Frame
Baseline, after 4 weeks of training, and 2 months after the end of training
Secondary Outcome Measure Information:
Title
Modified Barthel Index (MBI)
Description
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
Time Frame
Baseline, after 4 weeks of training, and 2 months after the end of training
Title
Tinetti Balance and Gait Scale (TBG)
Description
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
Time Frame
Baseline, after 4 weeks of training, and 2 months after the end of training
Title
10 Meter Walk Test (10MWT)
Description
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.
Time Frame
Baseline, after 4 weeks of training, and 2 months after the end of training
Title
Inertial sensors-based assessment
Description
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
Time Frame
Baseline, after 4 weeks of training, and 2 months after the end of training
Title
2 Minute Walking Test (2MWT)
Description
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
Time Frame
Baseline, after 4 weeks of training, and 2 months after the end of training
Title
2 Minute Walking Test (2MWT) associated with Cognitive Task
Description
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)
Time Frame
Baseline, after 4 weeks of training, and 2 months after the end of training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Marco Tramontano
City
Roma
ZIP/Postal Code
00179
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Cognitive-motor Dual Task Training in Patients With Multiple Sclerosis

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