Trial · NCT05983809
Technological Balance and Gait Rehabilitation in Patients With Multiple Sclerosis.
NCT05983809, Not applicable, Recruiting, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Technological Balance and Gait Rehabilitation in Patients With Multiple Sclerosis. Trials, record NCT05983809. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05983809
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Technological Balance and Gait Rehabilitation in Patients With Multiple Sclerosis.
- NCT number
- NCT05983809
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 24 participants, estimated
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Conditions
- Multiple Sclerosis, Balance, Cognitive Impairment
- Interventions
- Technological rehabilitation
- First posted
- 2023-08-09
- Last updated
- 2025-07-14
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Berg Balance Scale | Change from Baseline BBS at 4 and 8 weeks | The Berg Balance Scale (BBS) is used to objectively determine a patient's ability(or inability) to safely balance during a series of predetermined tasks. It is a 14item list with each item consisting of a five-point ordinal scale ranging from 0 to 4,with 0 indicating the lowest level of function and 4 the highest level of function andtakes approximately 20 minutes to complete. It does not include the assessmentof gait. |
| Secondary | Modified Fatigue Impact Scale (MFIS) | Change from Baseline MFIS at 4 and 8 weeks | The Modified Fatigue Impact Scale (MFIS) is an instrument that provides anassessment of the effects of fatigue in terms of physical, cognitive, andpsychosocial functioning. The full-length MFIS consists of 21 items while theabbreviated version has 5 items. The MFIS is a structured, self-report questionnaire that the patient can generallycomplete with little or no intervention from an interviewer. However, patients withvisual or upper extremity impairments may need to have the MFIS administeredas an interview. Interviewers should be trained in basic interviewing skills and inthe use of this instrument. The total score for the MFIS is the sum of the scores for the 21 items. Individualsubscale scores for physical, cognitive, and psychosocial functioning can also begenerated by calculating the sum of specific sets of items. |
| Secondary | Fatigue Scale for Motor and Cognitive Function (FSMC) | Change from Baseline FSMC at 4 and 8 weeks | The FSMC is an assessment of MS-related cognitive and motor fatigue. A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely')produces a score between 1 and 5 for each scored question. Thus minimumvalue is 20 (no fatigue at all) and maximum value is 100 (severest grade offatigue). Two subscales (mental and physical fatigue) can be made. Items included in the subscale mental are 1-4-7-8-11-13-15-17-18-20 and items included in the subscale physical are 2-3-5-6-9-10-12-14-16-19. |
| Secondary | Timed Up and Go test (TUG) | Change from Baseline TUG at 4 and 8 weeks | The Timed Up and Go test (TUG) measures in seconds the time it takes a subjectto rise from a chair, walk a distance of 3 meters, turn, walk back to the chair andsit down. The performance is rated on a scale of 1 to 5 (where 1 is normal and 5 is severelyabnormal) according to the observer's perception of the patient's risk of falling. The timed part of the test records the mean time (in seconds) from initial gettingup to re-seating. Patients are compared with the mean time of adults in their agegroup, 60 to 69, 70 to 79, and 80 to 99 years of age. |
| Secondary | Ambulation Index (AI) | Change from Baseline Ambulation Index at 4 and 8 weeks | Ambulation Index (AI) The Ambulation Index is a rating scale to assess mobility by evaluating the timeand degree of assistance required to walk 8 meters. Scores range from 0(asymptomatic and fully active) to 10 (bedridden). The patient is asked to walk amarked 8 meters course as quickly and safely as possible. The examiner recordsthe time and type of assistance (e.g., cane, walker, crutches) needed. Althoughthe patient's walking is timed, the time is not used directly but is utilized inconjunction with other factors to rate the patient on an ordinal scale with 11gradations. 0 = Asymptomatic; fully active. 10 = Bedridden |
| Secondary | Walking handicap scale (WHS) | Change from Baseline Walking handicap scale at 4 and 8 weeks | The Walking handicap scale (WHS) is an assessment tool that allows us toevaluate the quality of walking in the home and social environment through a ascale comprising six categories. 1 = Physiological walking: walking only as exercise 6 = Unrestricted walking insocial settings: independent in all activities, on uneven ground, in crowded places,shows complete independence in public places |
| Secondary | Functional Ambulation Classification (FAC) | Change from Baseline Functional Ambulation Classification at 4 and 8 weeks | The Functional Ambulation Categories (FAC) is a functional walking test thatevaluates ambulation ability. This 6-point scale assesses ambulation status bydetermining how much human support the patient requires when walking,regardless of whether or not they use a personal assistive device. A score of 0 indicates that the patient is a non-functional ambulator (cannot walk);A score of 1, 2 or 3 denotes a dependent ambulator who requires assistance fromanother person in the form of continuous manual contact (1), continuous orintermittent manual contact (2), or verbal supervision/guarding (3). A score of 4 or 5 describes an independent ambulator who can walk freely on:level surfaces only (4) or any surface (5=maximum score). |
| Secondary | 10 Meter Walk Test (10mWT) | Change from Baseline 10 Meter Walk Test at 4 and 8 weeks | The 10mWT is used to assess walking speed in meters/second (m/s) over a shortdistance. The total time taken to ambulate 6 meters (m) is recorded to the nearesthundredth of a second. 6 m is then divided by the total time (in seconds) taken toambulate and recorded in m/s. The time is measured for the middle 6 m to allow for patient acceleration anddeceleration. The time is started when any part of the leading foot crosses the plane of the 2-mmark. The time is stopped when any part of the leading foot crosses the plane of the 8-m mark.1 The time to walk the middle 6m, the level of assistance, and type ofassistive device and/or bracing used will be documented. If a patient requires total assistance or is unable to ambulate at all, a score of 0m/s will be documented. |
| Secondary | Six-minute walk test (6MWT) | Change from Baseline Six-minute walk test at 4 and 8 weeks | The six-minute walk test (6MWT) is a sub-maximal exercise test used to assesswalking endurance and aerobic capacity. Participants will walk around theperimeter of a set circuit for a total of six minutes. The score of the test is thedistance a patient walks in 6 minutes (measured in meters and can round to thenearest decimal point). Distance (in meters) covered in six minutes is calculated by multiplying thenumber of total laps by 12 meters and adding the distance of the partial lapcompleted at the time the test ended. |
| Secondary | Multiple Sclerosis Walking Scale (MSWS-12) | Change from Baseline Multiple Sclerosis Walking Scale at 4 and 8 weeks | The Multiple Sclerosis Walking Scale (MSWS-12) is a self-reported 12-item measure of an individual's ability to walk. Each item can be assigned a score from 1 to 5, where 1 means "no limitation" and 5 means "extreme limitation". The total score is obtained by summing the scores of the individual items; higher scores indicate a greater impact on walking than lower scores. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers17
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests2
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 |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05983809
GET https://conductscience.org/api/trials/v1/NCT05983809/registered