RehabilitationNCT06820125
Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation
A study testing Cognitive rehabilitation: CG group, Motor rehabilitation: MG group and Combined rehabilitation: CbG group in people with Rehabilitation and Multiple Sclerosis, run by Universita di Verona at 1 site in Italy.
Trial summary
The first aim of this project is to investigate the effects of different high-tech neurorehabilitation interventions (cognitive, motor, and combined cognitive-motor) on both cognitive and motor disability outcomes in people with multiple sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rehabilitation, Multiple Sclerosis, Cognitive Deficit
- What is being tested?
- Cognitive rehabilitation: CG group, Motor rehabilitation: MG group and Combined rehabilitation: CbG group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 5 Jul 2023to 5 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of mild (one or two neuropsychological tests below the cut-off score, 5th percentile) or severe (more than two neuropsychological tests below the cut-off score, 5th percentile) cognitive impairment,
- mild to moderate walking disability with Expanded Disability Status Scale (EDSS) between 3 and 6,
- no relapse or associated steroid use in the past three months,
- adequate visual and auditory capacity to operate computer software.
Who cannot join
- presence of other neurological disorders than MS,
- major psychiatric disorders,
- high levels of anxiety and/or depression (score>20 for Depression scale and up to 14 for Anxiety scale on Italian adaptation of the Depression, Anxiety and Stress Scale (DASS-21),
- substance abuse,
- any type of rehabilitation intervention in the month prior to recruitment
- pharmacological therapy not well defined and/or changed during the study
- presence of paroxysmal vertigo
- lower limb botulinum toxin injections within the previous 12 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Sezione medicina fisica e riabilitativa dipartimento di neuroscienze
Verona, verona, 37134
Nicola Smania, Direttore, 045 8124573, nicola.smania@univr.it
About this study
Official title: Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation in Patients with Multiple Sclerosis
The first aim of this project is to investigate the effects of different high-tech neurorehabilitation interventions (cognitive, motor, and combined cognitive-motor) on both cognitive and motor disability outcomes in people with multiple sclerosis (MS).
The second aim is to identify the cognitive and motor profiles of MS patients who benefit the most from either the combined cognitive-motor rehabilitation intervention or the isolated cognitive or motor treatments.
- Conditions
- Rehabilitation, Multiple Sclerosis, Cognitive Deficit, Motor Deficits
- Being tested
- Cognitive rehabilitation: CG group, Motor rehabilitation: MG group, Combined rehabilitation: CbG group
- Keywords
- rehabilitation, multiple sclerosis, cognitive deficits, motor deficits
- Medical subject headings
- Multiple Sclerosis, Cognition Disorders, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive rehabilitation: CG groupDevice
60 minutes of cognitive training with a computerized device
Motor rehabilitation: MG groupDevice
60 minutes of robot-assisted gait training with the G-EO System
Combined rehabilitation: CbG groupDevice
30 minutes of cognitive training with a computerized device + 30 minutes of robot-assisted gait training with the G-EO System. To mitigate the effects of fatigue in sequential training, the patients included in this group will undergo the cognitive (treatment CG) and motor (treatment MG) sessions in a counterbalanced order (half of the participants will follow the CG-MG sequence, and the other half will follow the MG-CG sequence). Five-minute breaks will be provided between the cognitive and motor sessions.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Group (CG) | Experimental | 60 minutes of cognitive training with a computerized device Receives: Device: Cognitive rehabilitation: CG group |
| Motor Group (MG) | Experimental | 60 minutes of robot-assisted gait training with the G-EO System Receives: Device: Motor rehabilitation: MG group |
| Combined Group (CbG) | Experimental | 30 minutes of cognitive training with a computerized device + 30 minutes of robot-assisted gait training with the G-EO System. Receives: Device: Combined rehabilitation: CbG group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symbol Digit Modalities Test
This test evaluates the visual information processing speed and attention; the number of correct answers in 90 seconds is registered (higher scores indicate better performance).
Measured: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatment
2-minute walking test
The 2MWT will be administered to measure self-paced walking ability. Patients will be asked to walk back and forth, as fast as they could, along a 30-m indoor corridor in 2 minutes. No talking will be permitted during the test. The distance walked (in meters) will be recorded (higher scores indicated better performance).
Measured: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatment
Secondary outcomes (12)
Brief Repeatable Battery (BRB)
The the Brief Repeatable Battery (BRB) is composed of the Selective Reminding Test - SRT (to evaluate verbal learning and delayed memory recall; the words recalled in three different subtests are recorded); the Spatial Recall Test - SPART (to evaluate visuospatial learning and delayed memory recall; the total number of correct responses for the three trials and the delayed recall trial are recorded); the SDMT (described above); the Paced Auditory Serial Addition Test - PASAT (to assesses auditory information processing speed, attention, and calculation; the score is the sum of correct answers recorded - max 60); the Word List Generation -WLG (to assesses semantic verbal fluency; the score is the number of correct words recorded).
Measured: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
The Stroop Test (ST)
The Stroop Test (ST), which evaluates attention and the ability to inhibit automatic responses. The Stroop effect is evaluated by computing a time interference effect (based on execution time) and an error interference effect (based on number of errors).
Measured: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
Trail Making Test (TMT)
The Trail Making Test (TMT), which consists of two parts: the TMT-A, used as a measure of psychomotor speed and visual search/attention skills, and the TMT-B, used as a measure of attentional set-shifting and mental flexibility. Time needed to complete the tasks is recorded.
Measured: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
The Verbal Fluency Test (VF)
The Verbal Fluency Test (VF), which is composed of 3 subtests: the Phonemic Fluency, the Semantic Fluency, and the Phonemic/Semantic Alternate Fluency test. For each trial, the number of correct words generated in 60 sec is recorded. Performance score in each subtest is the sum of the correct words generated in all trials.
Measured: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
The Modified Five Point Test (MFPT)
The Modified Five Point Test (MFPT), which is a measure of figural fluency assessing the ability to initiate mental productivity and self-monitoring during a visual-spatial task. Performance is assessed by scoring the total number of correct and unique designs generated in 3 min (UDs), and the total number of UDs produced into strategies (CSs).
Measured: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
Test of Attentional Performance (TAP; version 2.3.1)
The Test of Attentional Performance (TAP; version 2.3.1), which evaluates different aspects of attention; in particular, we will administer a Go/No-Go task, which examines the ability to perform an appropriate response under time pressure and to simultaneously inhibit an automatic behavioral response triggered by an external stimulus.
Measured: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
N-Back task
The N-Back task be made up of a sequence of stimuli, and the task consists of indicating when the current stimulus matches the one from n steps earlier in the sequence. The load factor n can be adjusted to increase the task difficulty. We will administer the visual N-Back available from a computerized device.
Measured: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
Time up and Go (TUG)
Time up and Go (TUG) will be administered to assess functional mobility of patients. In this test, patients have to stand up, walk 3 meters, turn around, walk back, and sit down. The time taken to complete the test is correlated with the level of functional mobility. Patients can perform the TUG also under a dual task condition in which they are required to count backwards from a randomly selected number between 20 and 100 while walking (TUG-COG). TUG-COG is considered a cognitive task because it investigates dual task ability.
The TUG is a good general indicator of locomotor function, but the timed global performance does not provide any information regarding the mechanisms underlying the patient's disabilities and specific problems relating to each sub-task are not highlighted.
Measured: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
eight-infrared camera system (sampling frequency: 60-120 fps) with the VICON Vero 2.2 motion analysis system (Vicon Motion Analysis System Ltd),
to specifically assess characteristics of gait, we will carry out gait analysis, which will be performed using an eight-infrared camera (sampling frequency of 60-120 fps) VICON Vero 2.2 motion analysis system (Vicon Motion Analysis System Ltd) synchronized with a two AMTI force plate. According to the Davis protocol, 16 reflective markers (14 mm diameter) will be positioned on the seventh cervical vertebra, the left and right anterior superior iliac spines (ASIS), the sacrum, the left and right mid-thighs, the left and right lateral femur condyles, the left and right mid-shanks, the left and right lateral malleoli, the dorsal aspect of the left and right feet (between the second and the third metatarsal head) and on the left and right calcanea [46]. Two analogue cameras will be integrated into the system and aligned with the sagittal and coronal planes. Gait cycle events (toe off and initial foot contact) will be defined automatically, using Vicon Clinical Manager software.
Measured: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
Modified Fatigue Impact Scale (MFIS)
To evaluate the patients' fatigue we will provide the Modified Fatigue Impact Scale (MFIS), a 21-items shortened version of the 40-items Fatigue Impact Scale. Although no basic analyses of the MFIS have been published, it has been used in clinical practice and several clinical trials and intervention studies
Measured: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
The Multiple Sclerosis Quality of Life-29 (MSQOL-29)
The Multiple Sclerosis Quality of Life-29 (MSQOL-29), the 29-items shortened version of the MSQOL-54, is a 29-item validated structured self-report questionnaire evaluating generic and MS-specific domains of health-related quality of life (QoL) in 7 multi-item subscales and 4 single-item subscales. Subscale scores are obtained by averaging the items within subscale and transforming the mean scores linearly to 0 to 100 possible scores. The higher the scores, the better the QoL. Physical Health Composite (PHC) and Mental Health Composite (MHC) are derived by combining scores of the subscales.
Measured: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
Client Satisfaction Questionnaire (CSQ-8)
a self-administered post-treatment questionnaire, comprised of eight items that evaluate the level of satisfaction regarding the care and quality of the service received and the level of fulfillment of the patient's expectations regarding the treatment administered. The total score of the questionnaire is 32 points, with higher values meaning higher satisfaction with the treatment received.
Measured: At the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start5 Jul 2023
- Primary completion5 Jul 2023
- Study completion5 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Smania, MD, Clinical Professor, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820125
- Sponsor's protocol ID
- 4257CESC
- Status last verified
- Dec 2024
- First submitted
- 24 Jan 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation in Patients with Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06820125
- Acronym / sponsor ID
- 4257CESC
- Conditions
- Rehabilitation, Multiple Sclerosis, Cognitive Deficit, Motor Deficits
- Keywords
- rehabilitation, multiple sclerosis, cognitive deficits, motor deficits
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2026 (estimated)
- First posted
- 11 Feb 2025 (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.
The first aim of this project is to investigate the effects of different high-tech neurorehabilitation interventions (cognitive, motor, and combined cognitive-motor) on both cognitive and motor disability outcomes in people with multiple sclerosis (MS).
The second aim is to identify the cognitive and motor profiles of MS patients who benefit the most from either the combined cognitive-motor rehabilitation intervention or the isolated cognitive or motor treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Group (CG) | Experimental | Device: Cognitive rehabilitation: CG group60 minutes of cognitive training with a computerized device |
| Motor Group (MG) | Experimental | Device: Motor rehabilitation: MG group60 minutes of robot-assisted gait training with the G-EO System |
| Combined Group (CbG) | Experimental | Device: Combined rehabilitation: CbG group30 minutes of cognitive training with a computerized device + 30 minutes of robot-assisted gait training with the G-EO System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- presence of mild (one or two neuropsychological tests below the cut-off score, 5th percentile) or severe (more than two neuropsychological tests below the cut-off score, 5th percentile) cognitive impairment,
- mild to moderate walking disability with Expanded Disability Status Scale (EDSS) between 3 and 6,
- no relapse or associated steroid use in the past three months,
- adequate visual and auditory capacity to operate computer software.
Key exclusion criteria (8 listed)
- presence of other neurological disorders than MS,
- major psychiatric disorders,
- high levels of anxiety and/or depression (score>20 for Depression scale and up to 14 for Anxiety scale on Italian adaptation of the Depression, Anxiety and Stress Scale (DASS-21),
- substance abuse,
- any type of rehabilitation intervention in the month prior to recruitment
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 |
|---|---|---|
| Cognitive rehabilitation: CG group60 minutes of cognitive training with a computerized device | Device | Cognitive Group (CG) |
| Motor rehabilitation: MG group60 minutes of robot-assisted gait training with the G-EO System | Device | Motor Group (MG) |
| Combined rehabilitation: CbG group30 minutes of cognitive training with a computerized device + 30 minutes of robot-assisted gait training with the G-EO System. To mitigate the effects of fatigue in sequential training, the patients included in this group will undergo the cognitive (treatment CG) and motor (treatment MG) sessions in a counterbalanced order (half of the participants will follow the CG-MG sequence, and the other half will follow the MG-CG sequence). Five-minute breaks will be provided between the cognitive and motor sessions. | Device | Combined Group (CbG) |
Primary outcome
Symbol Digit Modalities Test
Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatment
This test evaluates the visual information processing speed and attention; the number of correct answers in 90 seconds is registered (higher scores indicate better performance).
2-minute walking test
Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatment
The 2MWT will be administered to measure self-paced walking ability. Patients will be asked to walk back and forth, as fast as they could, along a 30-m indoor corridor in 2 minutes. No talking will be permitted during the test. The distance walked (in meters) will be recorded (higher scores indicated better performance).
12 secondary outcomes
Brief Repeatable Battery (BRB)
Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
The Stroop Test (ST)
Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
Trail Making Test (TMT)
Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
The Verbal Fluency Test (VF)
Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
The Modified Five Point Test (MFPT)
Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
Test of Attentional Performance (TAP; version 2.3.1)
Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
N-Back task
Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
Time up and Go (TUG)
Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
eight-infrared camera system (sampling frequency: 60-120 fps) with the VICON Vero 2.2 motion analysis system (Vicon Motion Analysis System Ltd),
Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
Modified Fatigue Impact Scale (MFIS)
Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
The Multiple Sclerosis Quality of Life-29 (MSQOL-29)
Time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
Client Satisfaction Questionnaire (CSQ-8)
Time frame: At the end of the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive rehabilitation: CG group, Motor rehabilitation: MG group and Combined rehabilitation: CbG group in people with Rehabilitation and Multiple Sclerosis, run by Universita di Verona 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 11 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valentina Varalta (045 8124956, valentina.varalta@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symbol Digit Modalities Test (time frame: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatment). The study lists 2 primary outcomes in all. 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 11 Feb 2025.