Exercise & Training

Interventional Feasibility Study Investigating Virtual Reality-Based Gait Assessment With Orthoses in People With Multiple Sclerosis: A Study Protocol.

TL;DR

This paper describes a protocol for an interventional feasibility study examining a novel VR-based framework combining immersive virtual reality and wearable sensors to support gait assessment with a passive walking brace in people with multiple sclerosis.

Key Findings

The study will enroll twelve participants with multiple sclerosis to evaluate the feasibility of a VR-based gait assessment framework combined with a passive walking brace.

  • Sample size of 12 participants with MS will be enrolled
  • The study is explicitly described as a pilot feasibility study and is 'not powered to assess clinical efficacy'
  • Statistical analysis will focus 'strictly on descriptive and exploratory comparisons across conditions and sessions'
  • Trial registered at ClinicalTrials.gov as NCT07096700, registered July 24, 2025

Each participant will undergo a protocol combining four ambulatory clinic sessions and a week-long home-monitoring phase.

  • The protocol includes four ambulatory sessions conducted in clinical settings
  • A week-long home-monitoring phase follows the clinical sessions
  • Standardized gait tests will be performed both with and without the walking brace
  • Testing will occur across both simulated VR scenarios and real-world conditions

Multimodal data will be collected via inertial and physiological wearable sensors to characterize a broad range of gait and physiological parameters.

  • Sensors will characterize spatiotemporal gait parameters, balance, posture, and physiological responses
  • Both inertial measurement units and physiological wearable sensors will be used
  • Data collection will be supplemented by standardized clinical scales and subjective questionnaires
  • The multimodal approach aims to reflect both clinical and daily-life conditions

Feasibility will be evaluated through multiple direct metrics including usability, acceptability, recruitment and retention rates, safety, protocol adherence, and data completeness.

  • User usability and acceptability are explicitly listed as primary feasibility outcomes
  • Recruitment and retention rates will be tracked as feasibility metrics
  • Safety monitoring is included as a feasibility dimension
  • Protocol adherence and data completeness are also specified feasibility endpoints

The study identifies that traditional clinical assessments for MS gait rely on subjective scales and may not fully reflect daily-life challenges, motivating the VR and wearable sensor approach.

  • Walking braces are commonly prescribed for MS-related gait impairment but their 'real-world effectiveness is limited by insufficient adaptation'
  • Traditional clinical assessments 'rely on subjective scales and may not fully reflect daily-life challenges'
  • Immersive VR and wearable sensors are described as 'promising solutions for ecological monitoring'
  • The combined use of VR and wearables 'remains unvalidated for orthotic support in MS'

The translational framework aims to establish robust feasibility metrics to inform the design of future larger-scale controlled trials and more ecologically valid, personalized rehabilitation strategies.

  • The study is explicitly framed as generating 'preliminary observations' to 'inform more ecologically valid, personalized rehabilitation strategies'
  • Results are intended to 'support the design of future, larger-scale controlled trials'
  • The ultimate goal described is 'to improve the integration of assistive technologies into patients' daily lives'
  • The framework is described as 'translational' in nature

What This Means

This research describes the design of a small pilot study testing whether virtual reality (VR) technology combined with body-worn sensors can be a practical and acceptable way to assess how people with multiple sclerosis (MS) walk, both with and without a leg brace. MS frequently causes problems with walking and balance, and while leg braces are often prescribed, they do not always help as much as hoped, partly because it is difficult to properly assess how well they work in everyday life. Standard clinical walking tests have limitations, so this study aims to test whether a more technologically advanced approach—using immersive VR environments alongside sensors that measure movement and body signals—is feasible and acceptable to patients. Twelve people with MS will participate in four clinic visits and one week of monitoring at home. During clinic visits, participants will walk with and without their brace in both real-world settings and simulated VR environments, while sensors record detailed information about their gait, balance, posture, and physical responses. The study will also collect information about how acceptable and usable the technology is, how many people complete the study, whether it is safe, and whether the data collected is complete and reliable. Because the study is small, it is not designed to prove whether the brace or the VR approach definitively helps—instead, it is gathering the information needed to properly design a much larger future study. This research matters because it is trying to develop better tools for evaluating walking aids in MS in conditions that more closely reflect real life. If the approach proves feasible and acceptable, it could eventually lead to more personalized and effective ways to prescribe and adapt assistive devices like leg braces, helping people with MS maintain independence and mobility in their daily lives.

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Citation

Marcaccini K, Aleo A, Pozzi S, Sgambato G, Chiari L, Verrengia M, et al.. (2026). Interventional Feasibility Study Investigating Virtual Reality-Based Gait Assessment With Orthoses in People With Multiple Sclerosis: A Study Protocol.. Clinical and translational science. https://doi.org/10.1111/cts.70728