VR and Orthoses for Rehabilitation in Multiple Sclerosis

NCT07096700 | Recruiting

• 1 other identifier: VIRTUE
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Neurorehabilitation; Gait impairments; Virtual Reality; Wearable technology; Sensor-based monitoring; Inertial sensors; Physiological signals; Walking braces; Remote monitoring

Outcome Measures

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.

  From T1 (day 2) to T2 (day 9)

Secondary Outcomes (13)

• NASA-TLX (NASA Task Load Index) questionnaire score

  T1 (day 2); T2 (day 10); T3 (day 70)

• MSAQ (Motion Sickness Assessment Questionnaire) questionnaire score

  T0 (day 1); T1 (day 2); T2 (day 10)

• IPQ (iGroupPresence Questionnaire) questionnaire score

  T1 (day 2); T2 (day 10)

• MusiQoL (Multiple Sclerosis International Quality of Life) questionnaire score

  T1 (day 2), T2 (day 10), T3 (day 70)

• BBS (Berg Balance Scale) questionnaire score

  T1 (day 2); T2 (day 10); T3 (day 70)

Study Arms (1)

VR - Multiple Sclerosis

OTHER

Twelve adults with multiple sclerosis who require a walking brace to support ambulation and are compatible with Virtual Reality

Other: VR and walking brace-based gait rehabilitation

Interventions

VR and walking brace-based gait rehabilitation OTHER

The 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.

VR - Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of multiple sclerosis
• Age between 18 and 65 years
• Both sexes
• Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS \> 100)
• Expanded Disability Status Scale (EDSS between 3 and 6 inclusive)
• Berg Balance Scale (BBS ≥ 46)
• Indication for the use of the Exoband orthosis for gait assistance
• Modified Fatigue Impact Scale (MFIS) physical subscale ≤ 20
• Signed informed consent

You may not qualify if:

• 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
• Presence of motion sickness symptoms induced by virtual reality (VR)

Sponsors & Collaborators

• Azienda Usl di Bologna: lead

Study Sites (2)

IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna

Bologna, Bologna, 40139, Italy

NOT YET RECRUITING

IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna

Bologna, BO, 40139, Italy

RECRUITING

Related Publications (9)

• Tsai MF, Bandini A, Wang RH, Zariffa J. Capturing Representative Hand Use at Home Using Egocentric Video in Individuals with Upper Limb Impairment. J Vis Exp. 2020 Dec 23;(166). doi: 10.3791/61898.

  PMID: 33427235 BACKGROUND

• Casuso-Holgado MJ, Martin-Valero R, Carazo AF, Medrano-Sanchez EM, Cortes-Vega MD, Montero-Bancalero FJ. Effectiveness of virtual reality training for balance and gait rehabilitation in people with multiple sclerosis: a systematic review and meta-analysis. Clin Rehabil. 2018 Sep;32(9):1220-1234. doi: 10.1177/0269215518768084. Epub 2018 Apr 13.

  PMID: 29651873 BACKGROUND

• Peruzzi A, Cereatti A, Della Croce U, Mirelman A. Effects of a virtual reality and treadmill training on gait of subjects with multiple sclerosis: a pilot study. Mult Scler Relat Disord. 2016 Jan;5:91-6. doi: 10.1016/j.msard.2015.11.002. Epub 2015 Nov 6.

  PMID: 26856951 BACKGROUND

• Bettoni E, Ferriero G, Bakhsh H, Bravini E, Massazza G, Franchignoni F. A systematic review of questionnaires to assess patient satisfaction with limb orthoses. Prosthet Orthot Int. 2016 Apr;40(2):158-69. doi: 10.1177/0309364614556836. Epub 2014 Nov 26.

  PMID: 25428901 BACKGROUND

• Marimon X, Mengual I, Lopez-de-Celis C, Portela A, Rodriguez-Sanz J, Herraez IA, Perez-Bellmunt A. Kinematic Analysis of Human Gait in Healthy Young Adults Using IMU Sensors: Exploring Relevant Machine Learning Features for Clinical Applications. Bioengineering (Basel). 2024 Jan 23;11(2):105. doi: 10.3390/bioengineering11020105.

  PMID: 38391591 BACKGROUND

• Panizzolo FA, Cimino S, Pettenello E, Belfiore A, Petrone N, Marcolin G. Effect of a passive hip exoskeleton on walking distance in neurological patients. Assist Technol. 2022 Sep 3;34(5):527-532. doi: 10.1080/10400435.2021.1880494. Epub 2021 Mar 5.

  PMID: 33481693 BACKGROUND

• Karunakaran KK, Pamula SD, Bach CP, Legelen E, Saleh S, Nolan KJ. Lower extremity robotic exoskeleton devices for overground ambulation recovery in acquired brain injury-A review. Front Neurorobot. 2023 May 25;17:1014616. doi: 10.3389/fnbot.2023.1014616. eCollection 2023.

  PMID: 37304666 BACKGROUND

• Homayuni A, Abedini S, Hosseini Z, Etemadifar M, Ghanbarnejad A. Explaining the facilitators of quality of life in patients with multiple sclerosis: a qualitative study. BMC Neurol. 2021 May 11;21(1):193. doi: 10.1186/s12883-021-02213-9.

  PMID: 33975555 BACKGROUND

• Gil-Gonzalez I, Martin-Rodriguez A, Conrad R, Perez-San-Gregorio MA. Quality of life in adults with multiple sclerosis: a systematic review. BMJ Open. 2020 Nov 30;10(11):e041249. doi: 10.1136/bmjopen-2020-041249.

  PMID: 33257490 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Loredana Sabattini

  IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Marcaccini

CONTACT

+390514966403; kevin.marcaccini@ausl.bologna.it

Loredana Sabattini

CONTACT

+3905174966217; loredana.sabattini@isnb.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: March 2, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)