Multiple SclerosisNCT04619953
Cognitive-motor Dual Task Training in Patients With Multiple Sclerosis
A study testing Dynamic Postural Stability Training, Cognitive-Motor Training and Conventional Therapy in people with Multiple Sclerosis and Cognitive Impairment, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Cognitive Impairment, Motor Disorders
- What is being tested?
- Dynamic Postural Stability Training, Cognitive-Motor Training and Conventional Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 9 Nov 2020to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Multiple Sclerosis, Cognitive Impairment, Motor Disorders
- Being tested
- Dynamic Postural Stability Training, Cognitive-Motor Training, Conventional Therapy
- Medical subject headings
- Multiple Sclerosis, Cognitive Dysfunction, Motor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Postural Stability TrainingOther
The dynamic postural stability training, will consist of marching on unstable surface and on treadmill both with open and with closed eyes.
Cognitive-Motor TrainingOther
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.
Conventional TherapyOther
The conventional neuromotor rehabilitation will consist in muscles stretching, active-assisted mobilizations, neuromuscular facilitations, gait training and balance exercises using swinging platforms
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Cognitive-Motor Training; Other: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, after 4 weeks of training, and 2 months after the end of training
Secondary outcomes (6)
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: Baseline, after 4 weeks of training, and 2 months after the end of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start9 Nov 2020
- Primary completion1 May 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Tramontano, I.R.C.C.S. Fondazione Santa Lucia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619953
- Sponsor's protocol ID
- CE/PROG.812
- Status last verified
- Jul 2023
- First submitted
- 28 Oct 2020
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychological Changes After Cognitive-motor Dual Task Training in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04619953
- Acronym / sponsor ID
- CE/PROG.812
- Conditions
- Multiple Sclerosis, Cognitive Impairment, Motor Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postural Stability group (PSg) | Active comparator | Other: Dynamic Postural Stability Training, Other: Conventional TherapyThe Postural Stability group (PSg) will perform 30 minutes of conventional neuromotor rehabilitation and 20 minutes of dynamic postural stability training. |
| Cognitive-Motor group (CMg) | Active comparator | Other: Cognitive-Motor Training, Other: Conventional TherapyThe Cognitive-Motor group (CMg) performed 30 minutes of conventional neuromotor rehabilitation and 20 minutes of cognitive-motor training. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Postural Stability TrainingThe dynamic postural stability training, will consist of marching on unstable surface and on treadmill both with open and with closed eyes. | Other | Postural Stability group (PSg) |
| Cognitive-Motor TrainingThe 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. | Other | Cognitive-Motor group (CMg) |
| Conventional TherapyThe conventional neuromotor rehabilitation will consist in muscles stretching, active-assisted mobilizations, neuromuscular facilitations, gait training and balance exercises using swinging platforms | Other | Cognitive-Motor group (CMg), Postural Stability group (PSg) |
Primary outcome
Balance Evaluation System Test (Mini-BESTest)
Time frame: 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.
6 secondary outcomes
Modified Barthel Index (MBI)
Time frame: Baseline, after 4 weeks of training, and 2 months after the end of training
Tinetti Balance and Gait Scale (TBG)
Time frame: Baseline, after 4 weeks of training, and 2 months after the end of training
10 Meter Walk Test (10MWT)
Time frame: Baseline, after 4 weeks of training, and 2 months after the end of training
Inertial sensors-based assessment
Time frame: Baseline, after 4 weeks of training, and 2 months after the end of training
2 Minute Walking Test (2MWT)
Time frame: Baseline, after 4 weeks of training, and 2 months after the end of training
2 Minute Walking Test (2MWT) associated with Cognitive Task
Time frame: Baseline, after 4 weeks of training, and 2 months after the end of training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Postural Stability Training, Cognitive-Motor Training and Conventional Therapy in people with Multiple Sclerosis and Cognitive Impairment, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance Evaluation System Test (Mini-BESTest) (time frame: Baseline, after 4 weeks of training, and 2 months after the end of training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.