Home-based EXergames To impRove cognitivE Function in MUltiple Sclerosis
NCT04169750, Not applicable, Unknown, San Camillo Hospital, Rome
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Home-based EXergames To impRove cognitivE Function in MUltiple Sclerosis | ClinicalTrials.gov |
| NCT number | NCT04169750 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 135 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | San Camillo Hospital, Rome | ClinicalTrials.gov |
| Conditions | Multiple Sclerosis | ClinicalTrials.gov |
| Interventions | Exergames, Adaptive COGNI-TRAcK, Sham COGNI-TRAcK | ClinicalTrials.gov |
| First posted | 2019-11-20 | ClinicalTrials.gov |
| Last updated | 2021-10-01 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Symbol Digit Modalities Test | Change from randomization to 8-week visit | The participant is presented with a page headed by a key that pairs the single digits 1-9 with nine symbols. Rows below contain only symbols, the subject's task is to orally report the correct number in the spaces below. After completing the first 10 items with guidance, the subject is timed to determine how many responses can be made in 90 seconds. Range score: not applicable. Higher scores mean a better outcome. Explored domain: Sustained attention and information processing speed. | ClinicalTrials.gov |
| Secondary | Brief International Cognitive Assessment for Multiple Sclerosis | At randomization, 8 weeks and 16 weeks | Brief cognitive assessment for multiple sclerosis that includes the Symbol Digit Modalities Test (SDMT) for exploring sustained attention, the initial learning trials of the second edition of the California Verbal Learning Test (CVLT2) for exploring auditory/verbal learning, and the revised Brief Visuospatial Memory Test (BVMTR) for exploring visual/spatial memory. Range score: not applicable. Higher scores mean a better outcome. | ClinicalTrials.gov |
| Secondary | Stroop Color-Word Test | At randomization, 8 weeks and 16 weeks | The test explores some aspects of executive functions and consists of naming the color of the ink of words, indicating conflicting colors as quickly as possible. Range score: not applicable. Higher scores mean a better outcome. | ClinicalTrials.gov |
| Other | Cognitive-Motor Interference | At randomization, 8 weeks and 16 weeks | Dual-task cost of walking (2-Meter Walking Test) and balance (static posturography) is calculated as percentage change in scores obtained under single-task condition minus dual-task condition divided by the score under single-task condition. Range score: not applicable (negative values are possible). Higher scores mean a better outcome. | ClinicalTrials.gov |
| Other | 29-item Multiple Sclerosis Impact Scale | At randomization, 8 weeks and 16 weeks | The Multiple Sclerosis Impact Scale (MSIS-29) is a 29-item self-administered questionnaire measuring physical and psychological impact of multiple sclerosis from the patient's perspective. Range score: 0 to 100. Higher scores mean worse outcome. | ClinicalTrials.gov |
| Other | 21-item Modified Fatigue Impact Scale | At randomization, 8 weeks and 16 weeks | The Modified Fatigue Impact Scale (MFIS) is a 21-item self-administered questionnaire based on items derived from interviews with patients with multiple sclerosis concerning how fatigue impacts their lives; it comprises three subscales (physical, cognitive, and psychosocial functioning). Range score: 0 to 84. Higher scores mean worse outcome. | ClinicalTrials.gov |
| Other | Work Productivity and Activity Impairment: Multiple Sclerosis | At randomization, 8 weeks and 16 weeks | To quantify absenteeism (missing work because of health problems), presenteeism (impairment while working), overall work impairment, and daily activity impairment attributable to multiple sclerosis. Range score: 0 to 100. Higher scores mean worse outcome. | ClinicalTrials.gov |
| Other | Time to first accidental falls | From randomization to study termination (16 weeks) | Time to randomization to the first accidental falls reported by the participant, defined as an event which results in a person coming to rest inadvertently on the ground or floor or other lower level (WHO). Range score: not applicable. | ClinicalTrials.gov |
| Other | Adverse events | From randomization to study termination (16 weeks) | Any untoward medical occurrence in participants which does not necessarily have a causal relationship with the administered intervention. Range score: not applicable. | 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 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 41033785 | DERIVED | 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 |
|---|---|---|
| Symbol Coding | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Verbal Learning | 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)