Quantifying Gait Disorders With Wearable Sensors

Quantification of Gait Differences Between Healthy Volunteers and Patients Suffering From Gait Disorders Through Wearable Sensors

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 Overview

• Status: Not yet recruiting
• Conditions: Gait Disorders
• Intervention / Treatment: Other: Gait assessment

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Sandro Iannaccone, Neurologist; Phone Number: +390226435734; Email: iannaccone.sandro@hsr.it

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20132
      • IRCCS Ospedale San Raffaele
      • Contact: Sandro Iannaccone; Phone Number: +390226435734; Email: iannaccone.sandro@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients (n = 50)

• Age 18-80 years, male and female
• Hospitalized in the Department of Rehabilitation and Functional Recovery (IRCCS Ospedale San Raffaele - Milan) with clinically diagnosed gait impairments
• Able to ambulate independently and safely with or without assistive devices
• Undergoing standard gait-rehabilitation sessions at IRCCS Ospedale San Raffaele

Healthy Volunteers (n = 50)

• Age- and sex-matched to the patient cohort
• No history of neurological, musculoskeletal, or cardiovascular conditions affecting gait
• Willing and able to participate in three 18 meters gait evaluation with sensors

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy volunteers	Other: Gait assessment; Gait assessment with wearable sensors
Patients	Other: Gait assessment; Gait assessment with wearable sensors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (single time point)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (single time point)

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Estimated): March 2, 2026
• Primary Completion (Estimated): January 8, 2028
• Study Completion (Estimated): January 8, 2028

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Mobility Limitation
• Other Study ID Numbers: GAIT-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No