VR and Orthoses for Rehabilitation in Multiple Sclerosis
ConditionMultiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAzienda Usl di Bologna
About this trial
This non-drug, non-medical device, interventional study explores the feasibility of integrating virtual reality (VR) with wearable sensors to support gait training using a passive orthosis in individuals with multiple sclerosis (MS). The aim is to determine whether this approach can enhance clinical gait assessment and facilitate orthosis adaptation by replicating real-life scenarios within a safe and controlled environment. The virtual environment, accessed through a head-mounted display, will be delivered via a custom simulator incorporating standardized gait tasks embedded in everyday settings. This system is designed to minimize the artificial influence of clinical settings on walking performance, while providing clinicians with objective gait data for more comprehensive evaluation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed diagnosis of multiple sclerosis
Age between 18 and 65 years
Both sexes
Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS > 100)
Disqualifiers
Presence of severe or current visual or auditory impairments
Relapses within the last 3 months
Presence of severe anxiety or depression
Severe spasticity patterns in the lower limbs or fixed distal tendon contractures
Trial design
Design model
Single group
Treatments tested in this trial
VR and walking brace-based gait rehabilitation
Other interventionThe study implements the use of VR and wearable sensors to enhance gait analysis in clinical practice. Participants will take part in two outpatient sessions (T1 and T2) involving the use of VR and wearable sensors, during which they will be asked to complete standardized gait tests and questionnaires. These two sessions will be separated by a one-week home phase (Th), during which participants will wear the walking brace in their daily activities and their gait and physiological data will be recorded by wearable sensors. A final session (T3), conducted without VR, will be scheduled two months later to assess the long-term retention of the intervention effects.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: VR - Multiple SclerosisOther 1 intervention
Trial outcomes
Primary outcomes
1
Score of the standardized tests and gait parameters
This outcome assesses the adaptation to the walking brace during ambulation. Gait performance across different sessions will be analyzed and compared to observe improvement between T1 and T2. Participant satisfaction with the use of VR will be considered met if individuals can successfully engage with and complete the sessions using the system.
Time frame
From T1 (day 2) to T2 (day 9)Secondary outcomes
1
NASA-TLX (NASA Task Load Index) questionnaire score
The NASA-TLX questionnaire score (National Aeronautics and Space Administration Task Load Index) measures physical and mental workload using six items related to mental load, physical activity, speed of performance, performance, effort, and frustration. Each item is accompanied by a 12 cm line scale divided into 20 equal intervals, anchored by binary descriptors (e.g., low/high), delimited by 21 vertical markers, and then converted to a scale from 0 to 100 points. To calculate the score for each scale, the number of lines marked by a participant is counted, 1 is subtracted, and the result is multiplied by 5. Weights from 0-5 will be assigned to the 15 subscale comparisons, which will be multiplied by the corresponding subscale score. The total score (from 0 to 100 points) is estimated by summing the weighted scores and dividing by 15.
Time frame
T1 (day 2); T2 (day 10); T3 (day 70)2
MSAQ (Motion Sickness Assessment Questionnaire) questionnaire score
The MSAQ questionnaire assesses motion sickness. It consists of 16 questions divided into four subcategories: Gastrointestinal (G), Central (C), Peripheral (P), and Sopite-related (S). Responses are scored on a scale from 1 to 9 points. Each subcategory is scored individually, contributing to a total score ranging from 11 to 144 points. The overall motion sickness score is calculated as the percentage of total points scored: (sum of all item points / 144) × 100. Subscale scores are calculated similarly as percentages within each factor: (sum of gastrointestinal items / 36) × 100; (sum of central items / 45) × 100; (sum of peripheral items / 27) × 100; (sum of sopite items / 36) × 100.
Time frame
T0 (day 1); T1 (day 2); T2 (day 10)3
IPQ (iGroupPresence Questionnaire) questionnaire score
The IPQ questionnaire assesses the sense of presence (SOP - level of immersion in VR) of a VR user. The IPQ consists of 14 items divided into four subcategories: spatial presence, involvement, perceived realism level, and a "sense of being present." All items are rated on a seven-point scale (0-6), with a higher score indicating greater SOP. The total score is obtained by summing the scores of individual items (from 0 to 84 points).
Time frame
T1 (day 2); T2 (day 10)4
MusiQoL (Multiple Sclerosis International Quality of Life) questionnaire score
The MusiQoL questionnaire assesses health-related quality of life specifically in individuals with multiple sclerosis. It consists of 31 items grouped into nine dimensions: daily activities, psychological well-being, symptoms, social relationships, family relationships, relationship with healthcare professionals, emotional well-being, intimate relationships, and leisure activities. Each item is rated on a five-point Likert scale (from 1 = "never" to 5 = "always"). Scores for each dimension are calculated as the mean of the corresponding items, then transformed into a 0-100 scale, with higher scores indicating better quality of life.
Time frame
T1 (day 2), T2 (day 10), T3 (day 70)Sponsors and contacts
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Source ClinicalTrials.gov