Tele-rehabilitation Program in People With Multiple Sclerosis and Mild Disability
NCT07924410, Not applicable, Active not recruiting, IRCCS San Raffaele Roma
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Tele-rehabilitation Program in People With Multiple Sclerosis and Mild Disability | ClinicalTrials.gov |
| NCT number | NCT07924410 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 120 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | IRCCS San Raffaele Roma | ClinicalTrials.gov |
| Conditions | Multiple Sclerosis, Fatigue in Multiple Sclerosis | ClinicalTrials.gov |
| Interventions | Multidomain Home-Based Telerehabilitation Program, Self-Managed Educational Program | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Cost of walking - CW | Day 1 (T0 - baseline) ; After 6 weeks from day 1 (T1 - end of treatment) | Cost of Walking (CW) represents the energy expenditure required to walk at a given speed and provides an index of walking efficiency. It will be assessed through cardiopulmonary exercise testing (CPET), based on oxygen consumption (VO₂), carbon dioxide production (VCO₂), and other metabolic parameters. Lower CW values indicate greater walking efficiency. | ClinicalTrials.gov |
| Secondary | Fatigue Severity Scale (FSS) | Day 1 (T0 - baseline) ; After 6 weeks from day 1 (T1 - end of treatment) | The Fatigue Severity Scale (FSS) is a standardized self-reported questionnaire used to assess the severity of fatigue and its impact on daily activities and functional performance. It consists of 9 items, each rated on a 7-point Likert scale (1 = strongly disagree; 7 = strongly agree). The total score ranges from 9 to 63, with higher scores indicating greater fatigue severity and a more significant impact on daily functioning. The FSS is widely used in clinical practice and research to evaluate fatigue and monitor changes over time. | ClinicalTrials.gov |
| Secondary | Modified Fatigue Impact Scale (MFIS) | Day 1 (T0 - baseline) ; After 6 weeks from day 1 (T1 - end of treatment) | The Modified Fatigue Impact Scale (MFIS) is a standardized self-reported questionnaire used to assess the impact of fatigue on daily functioning and quality of life. It consists of 21 items covering three main domains: physical, cognitive, and psychosocial functioning. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (almost always). The total score ranges from 0 to 84, with higher scores indicating a greater impact of fatigue on daily activities. The MFIS is widely used in clinical practice and research to evaluate fatigue-related limitations, particularly in patients with neurological disorders, and to monitor changes in fatigue impact over time. | ClinicalTrials.gov |
| Secondary | Visual Analog Scale (VAS) | Day 1 (T0 - baseline) ; After 6 weeks from day 1 (T1 - end of treatment) | The Visual Analog Scale (VAS) is a standardized self-reported assessment tool used to measure the intensity of subjective symptoms, particularly pain. It typically consists of a 100-mm horizontal line, anchored by two endpoints representing "no pain" (0) and "worst imaginable pain" (100). Participants are asked to mark the point that best reflects their perceived pain intensity. The score ranges from 0 to 100 mm, with higher scores indicating greater pain intensity. The VAS is widely used in clinical practice and research to assess pain severity, evaluate treatment effectiveness, and monitor changes in symptom intensity over time. | ClinicalTrials.gov |
| Secondary | Montreal Cognitive Assessment Test (MoCa) | Day 1 (T0 - baseline) ; After 6 weeks from day 1 (T1 - end of treatment) | The Montreal Cognitive Assessment (MoCA) is a standardized cognitive screening tool used to assess global cognitive function and detect mild cognitive impairment. It evaluates several cognitive domains, including attention, concentration, executive functions, memory, language, visuospatial abilities, abstraction, calculation, and orientation. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. A score below 26 is commonly considered suggestive of cognitive impairment, although interpretation should account for age, education, and clinical context. The MoCA is widely used in clinical practice and research to identify cognitive deficits and monitor changes in cognitive function over time, particularly in patients with neurological disorders. | ClinicalTrials.gov |
| Secondary | Symbol Digit Modalities Test (SDMT) | Day 1 (T0 - baseline) ; After 6 weeks from day 1 (T1 - end of treatment) | The Symbol Digit Modalities Test (SDMT) is a standardized neuropsychological assessment tool used to evaluate cognitive processing speed, attention, visual scanning, and working memory. The test requires participants to match geometric symbols with corresponding numbers using a predefined reference key within 90 seconds. It can be administered in written or oral form. The total score represents the number of correct symbol-digit substitutions, with higher scores indicating better cognitive performance. The SDMT is widely used in clinical practice and research to detect cognitive impairment and monitor changes in cognitive processing speed over time, particularly in patients with neurological disorders such as multiple sclerosis. | ClinicalTrials.gov |
| Secondary | Paced Auditory Serial Addition Test (PASAT) | Day 1 (T0 - baseline) ; After 6 weeks from day 1 (T1 - end of treatment) | The Paced Auditory Serial Addition Test (PASAT) is a standardized neuropsychological assessment tool used to evaluate sustained and divided attention, working memory, information processing speed, and auditory processing abilities. During the test, participants listen to a sequence of single-digit numbers presented at fixed time intervals and are required to continuously add each new number to the immediately preceding one. The test is commonly administered using 3-second (PASAT-3) or 2-second (PASAT-2) intervals. Performance is assessed by the number of correct responses, with higher scores indicating better cognitive performance. In the commonly used 60-item version, scores range from 0 to 60. The PASAT is widely used in clinical practice and research to detect cognitive impairment and monitor changes in cognitive functioning over time, particularly in patients with neurological disorders such as multiple sclerosis. | ClinicalTrials.gov |
| Secondary | State-Trait Anxiety Inventory (STAI) | Day 1 (T0 - baseline) ; After 6 weeks from day 1 (T1 - end of treatment) | The State-Trait Anxiety Inventory (STAI) is a standardized self-reported questionnaire used to assess anxiety levels by distinguishing between state anxiety (temporary anxiety experienced in a specific situation) and trait anxiety (a relatively stable tendency to experience anxiety). It consists of 40 items divided into two subscales of 20 items each: State Anxiety (STAI-S) and Trait Anxiety (STAI-T). Each item is rated on a 4-point Likert scale, with each subscale yielding a total score ranging from 20 to 80. Higher scores indicate greater levels of anxiety. The STAI is widely used in clinical practice and research to evaluate psychological distress, assess anxiety symptoms, and monitor changes in anxiety levels over time, particularly in patients with neurological and chronic conditions. | ClinicalTrials.gov |
| Secondary | Beck Depression Inventory (BDI) | Day 1 (T0 - baseline) ; After 6 weeks from day 1 (T1 - end of treatment) | The Beck Depression Inventory (BDI) is a standardized self-reported questionnaire used to assess the severity of depressive symptoms. It consists of 21 items evaluating cognitive, emotional, behavioral, and somatic symptoms associated with depression, including sadness, pessimism, loss of interest, fatigue, and sleep disturbances. Each item is rated on a 4-point scale ranging from 0 to 3, yielding a total score from 0 to 63, with higher scores indicating greater severity of depressive symptoms. The BDI is widely used in clinical practice and research to assess depressive symptomatology, evaluate psychological well-being, and monitor changes in depression severity over time, particularly in patients with neurological and chronic conditions. | ClinicalTrials.gov |
| Secondary | Expanded Disability Status Scale (EDSS) | Day 1 (T0 - baseline) ; After 6 weeks from day 1 (T1 - end of treatment) | The Expanded Disability Status Scale (EDSS) is a standardized clinical assessment tool used to evaluate neurological impairment and disability in people with multiple sclerosis (MS). It assesses neurological function across eight Functional Systems, including pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral (mental), and other neurological functions. The total score ranges from 0 to 10 in 0.5-point increments, with 0 indicating a normal neurological examination and 10 representing death due to MS. Lower scores primarily reflect neurological impairment, while higher scores increasingly emphasize walking limitations and dependence on assistance. The EDSS is widely used in clinical practice and research to assess disease severity, monitor disability progression, and evaluate treatment outcomes over time in people with multiple sclerosis. | ClinicalTrials.gov |
| Secondary | 6 Minute Walking Test (6MWT) | Day 1 (T0 - baseline) ; After 6 weeks from day 1 (T1 - end of treatment) | The 6-Minute Walk Test (6MWT) is a standardized functional assessment tool used to evaluate walking endurance and functional exercise capacity. It measures the total distance walked in meters over a period of 6 minutes, during which participants are instructed to walk as far as possible at a self-selected pace along a standardized walkway. The total distance covered represents the primary outcome measure, with greater distances indicating better functional exercise capacity and walking endurance. The 6MWT is widely used in clinical practice and research to assess functional mobility and monitor changes in walking performance over time, particularly in patients with neurological, cardiovascular, and respiratory disorders. | ClinicalTrials.gov |
| Secondary | Timed Up and Go test (TUG) | Day 1 (T0 - baseline) ; After 6 weeks from day 1 (T1 - end of treatment) | The Timed Up and Go (TUG) is a standardized clinical assessment tool used to evaluate functional mobility, dynamic balance, and fall risk. The test measures the time required, in seconds, for a participant to stand up from a chair, walk a distance of 3 meters at a comfortable and safe pace, turn around, walk back to the chair, and sit down. The total completion time represents the primary outcome measure, with shorter times indicating better functional mobility and balance performance. The TUG is widely used in clinical practice and research to assess mobility limitations and monitor changes in functional performance over time, particularly in patients with neurological and musculoskeletal disorders. | ClinicalTrials.gov |
| Secondary | TUG - Dual Task (TUG-DT) | Day 1 (T0 - baseline) ; After 6 weeks from day 1 (T1 - end of treatment) | The Timed Up and Go Dual Task (TUG-DT) is a standardized clinical assessment tool used to evaluate functional mobility, dynamic balance, and cognitive-motor interference under dual-task conditions. The test measures the time required, in seconds, for a participant to stand up from a chair, walk a distance of 3 meters, turn around, walk back to the chair, and sit down while simultaneously performing a secondary cognitive task, such as counting backward or verbal fluency. The total completion time represents the primary outcome measure, with shorter times indicating better dual-task mobility performance. The TUG-DT is widely used in clinical practice and research to assess cognitive-motor interactions, identify mobility limitations, and monitor changes in dual-task performance over time, particularly in patients with neurological disorders. | ClinicalTrials.gov |
| Secondary | 54-item Multiple Sclerosis Quality of Life (MSQOL-54) | Day 1 (T0 - baseline) ; After 6 weeks from day 1 (T1 - end of treatment) | 54-item Multiple Sclerosis Quality of Life (MSQOL-54) The 54-item Multiple Sclerosis Quality of Life Questionnaire (MSQOL-54) is a standardized self-reported assessment tool used to evaluate health-related quality of life in patients with multiple sclerosis (MS). It consists of 54 items, combining the 36-item Short Form Health Survey (SF-36) with 18 additional MS-specific items. The questionnaire assesses several domains, including physical functioning, emotional well-being, pain, fatigue, cognitive functioning, social functioning, sexual function, and overall quality of life. Domain scores are transformed to a 0-100 scale, with higher scores generally indicating better health-related quality of life. Two composite scores, the Physical Health Composite and Mental Health Composite, can also be calculated. The MSQOL-54 is widely used in clinical practice and research to assess the impact of multiple sclerosis on daily life, evaluate treatment outcomes, and monitor changes in quality of | ClinicalTrials.gov |
| Other | Sway area and Center of Pressure (CoP) | Day 1 (T0 - baseline) ; After 6 weeks from day 1 (T1 - end of treatment) | These measurements are acquired during a static balance test performed with eyes open and eyes closed; Kistler stabilometric platforms (1000 Hz, Kistler Group, Winterthur, Switzerland) will be used. | ClinicalTrials.gov |
| Other | Spatio-temporal parameters | Day 1 (T0 - baseline) ; After 6 weeks from day 1 (T1 - end of treatment) | Gait analysis with Inertial Measurement Units (IMUs) | ClinicalTrials.gov |
| Other | Epstein-Barr virus (EBV) serological status and reactivation markers | Day 1 (T0 - baseline) ; After 6 weeks from day 1 (T1 - end of treatment) | anti-EBV antibodies and EBV DNA quantification | 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 29
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 3343627 | BACKGROUND | PubMed |
| 10575082 | BACKGROUND | PubMed |
| 12785244 | BACKGROUND | PubMed |
| 16916440 | BACKGROUND | PubMed |
| 17405806 | BACKGROUND | PubMed |
| 20809053 | BACKGROUND | PubMed |
| 21685232 | BACKGROUND | PubMed |
| 23468871 | BACKGROUND | PubMed |
| 23592979 | BACKGROUND | PubMed |
| 24697509 | BACKGROUND | PubMed |
| 25740864 | BACKGROUND | PubMed |
| 27728987 | BACKGROUND | PubMed |
| 28416274 | BACKGROUND | PubMed |
| 28604802 | BACKGROUND | PubMed |
| 29027539 | BACKGROUND | PubMed |
| 29748963 | BACKGROUND | PubMed |
| 30637728 | BACKGROUND | PubMed |
| 31578295 | BACKGROUND | PubMed |
| 31780252 | BACKGROUND | PubMed |
| 31919582 | BACKGROUND | PubMed |
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 3
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 |
|---|---|---|
| Paced Visual Serial Addition Test | Secondary outcome | ConductCognition |
| Symbol Coding | 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)