Quantifying Gait Disorders With Wearable Sensors

IRCCS San Raffaele100 enrolled

Overview

This is a single-centre, cross-sectional observational study with adjunctive procedure for the healthy voluteers at IRCCS Ospedale San Raffaele's Rehabilitation Department. Patients (n=50): use of inertial measurement units (IMU) and electromyographic (EMG) data routinely acquired during their standard clinical gait-rehabilitation sessions (no protocol changes; purely observational, data extracted from treatments). Healthy volunteers (n=50): age- and sex-matched volunteers who complete three 18 meters gait sessions with IMUs on trunk, thighs, shanks and feet and surface EMG on gluteus, quadriceps, hamstrings, tibialis anterior, and gastrocnemius. Healthy volunteers will be enrolled from hospital personnel, family members of the patients in visit at San Raffaele Hospital. Data \& Analysis: Kinematic (range of motion - ROM, step timing, walking speed) and EMG (activation amplitude/timing) parameters will be extracted. Between-group comparisons will employ t-tests/analysis of variance - ANOVA - (or non-parametric equivalents).

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Gait Disorders

Interventions

Gait assessmentOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Hospitalized at the Department of Rehabilitation and Functional Recovery of IRCCS Ospedale San Raffaele - Milan (during the hospitalization period) * Ability to understand and sign informed consent * ≥ 18 years ≤80 years * Male and female * Presence of clinically diagnosed gait impairments * No skin conditions or allergies preventing sensor application Exclusion Criteria: * Cognitive impairment interfering with task comprehension * Cardiorespiratory instability or other contraindications to walking assessment

Outcomes

Primary Outcomes

Mean differences in joint range of motion expressed in degrees of movement (hip, knee, ankle) measured by sensors (Inertial Measurement Units) between patients and healthy volunteers

Joint range of motion of the hip, knee, and ankle measured using inertial measurement units (IMUs) and expressed in degrees (°). The outcome represents the mean difference in joint range of motion between patients and healthy volunteers; higher values indicate greater angular excursion of the joint.

Time frame: Baseline (single time point)

Secondary Outcomes

Average of the normalized enveloped of surface electromyography signals

Surface electromyography (sEMG) signals processed to obtain the signal envelope and then normalized. The outcome measure represents the average normalized sEMG envelope amplitude, providing an index of muscle activation level over the analyzed task; higher values indicate greater muscle activation relative to the normalization reference.