Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation
NCT06820125, Not applicable, Recruiting, Universita di Verona
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Isolated Versus Combined Cognitive and Motor High-tech Rehabilitation | ClinicalTrials.gov |
| NCT number | NCT06820125 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 48 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Universita di Verona | ClinicalTrials.gov |
| Conditions | Rehabilitation, Multiple Sclerosis, Cognitive Deficit, Motor Deficits | ClinicalTrials.gov |
| Interventions | Cognitive rehabilitation: CG group, Motor rehabilitation: MG group, Combined rehabilitation: CbG group | ClinicalTrials.gov |
| First posted | 2025-02-11 | ClinicalTrials.gov |
| Last updated | 2025-02-11 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Symbol Digit Modalities Test | 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). | ClinicalTrials.gov |
| Primary | 2-minute walking test | 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). | ClinicalTrials.gov |
| Secondary | Brief Repeatable Battery (BRB) | The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen | 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). | ClinicalTrials.gov |
| Secondary | The Stroop Test (ST) | 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), 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). | ClinicalTrials.gov |
| Secondary | Trail Making Test (TMT) | The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen | 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. | ClinicalTrials.gov |
| Secondary | The Verbal Fluency Test (VF) | 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), 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. | ClinicalTrials.gov |
| Secondary | The Modified Five Point Test (MFPT) | 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), 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). | ClinicalTrials.gov |
| Secondary | Test of Attentional Performance (TAP; version 2.3.1) | The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen | 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. | ClinicalTrials.gov |
| Secondary | N-Back task | The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen | 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. | ClinicalTrials.gov |
| Secondary | Time up and Go (TUG) | 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) 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. | ClinicalTrials.gov |
| Secondary | eight-infrared camera system (sampling frequency: 60-120 fps) with the VICON Vero 2.2 motion analysis system (Vicon Motion Analysis System Ltd), | The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen | 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. | ClinicalTrials.gov |
| Secondary | Modified Fatigue Impact Scale (MFIS) | The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen | 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 | ClinicalTrials.gov |
| Secondary | The Multiple Sclerosis Quality of Life-29 (MSQOL-29) | 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 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. | ClinicalTrials.gov |
| Secondary | Client Satisfaction Questionnaire (CSQ-8) | At the end of the treatment | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 12
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Symbol Coding | Primary outcome | ConductCognition |
| 1-Back Task | Secondary outcome | ConductCognition |
| 2-Back Task | Secondary outcome | ConductCognition |
| Category Fluency | Secondary outcome | ConductCognition |
| Design Fluency Test | Secondary outcome | ConductCognition |
| Go/No-Go Task | Secondary outcome | ConductCognition |
| Paced Visual Serial Addition Test | Secondary outcome | ConductCognition |
| Selective Reminding Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)