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NOT YET RECRUITING
NCT07878702
NA

Dual-Task Balance Training in People With Multiple Sclerosis: a Randomized Feasibility Study

Sponsor: Universita di Verona

View on ClinicalTrials.gov

Summary

The goal of this randomized controlled feasibility study is to assess whether a balance training program that includes dual-task exercises is feasible in people with multiple sclerosis (MS). The study also aims to obtain preliminary data on the effects of the training on walking under dual-task conditions and on brain activity recorded with a wearable EEG. The main questions it aims to answer are: * Is the training feasible in terms of recruitment, retention, adherence, data completeness, and assessment burden? * What are the preliminary effects of the training on dual-task costs during the Timed Up and Go test (TUG) and the 2-Minute Walk Test (2MWT), on prefrontal activation and mental workload during walking, and on clinical outcomes? Researchers will compare participants who receive the training with participants who receive no additional rehabilitation during the study period. Participants will: * receive 14 in-hospital sessions of balance and dual-task training (60 minutes, 2 sessions per week, about 7 weeks) if allocated to the intervention group, or no new rehabilitation if allocated to the control group; * perform a dual-task walking assessment (TUG, 2MWT, backward digit span) while wearing an 8-channel wearable EEG headset and 3 inertial sensors, before (T0) and after (T1) the study period; * complete clinical scales and questionnaires on balance, gait, cognition, fatigue, mood, pain, and quality of life.

Official title: Neural Correlates of Motor-cognitive Interaction During Walking in People With Multiple Sclerosis: a Cross-sectional and a Feasibility Study of a Dual-task Rehabilitation Intervention

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-10-15

Completion Date

2029-09-30

Last Updated

2026-10-16

Healthy Volunteers

No

Interventions

BEHAVIORAL

Dual-task balance training

Each 60-min session includes warm-up (5 min), static balance exercises (15 min), dynamic balance exercises (15 min), dual-task training combining dynamic balance exercises with cognitive tasks (20 min), and cool-down (5 min). Exercise difficulty progresses by manipulating base of support, visual, somatosensory and vestibular input, concurrent upper-limb movements, walking direction, and obstacle height. Progression requires three consecutive successful repetitions. Cognitive tasks include serial subtraction by 3 and 7, alternate alphabet recitation, and verbal fluency, with difficulty set to keep about 70% correct responses. The training is tailored to each participant's functional level.

Locations (1)

Policlinico GB Rossi - University Hospital Borgo Roma

Verona, Verona, Italy