Quantifying Gait Disorders With Wearable Sensors

NCT07473141 | Recruiting DMC

• 1 other identifier: GAIT-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Gait Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Average of the normalized enveloped of surface electromyography signals

  Baseline (single time point)

Study Arms (2)

Patients

Other: Gait assessment

Healthy volunteers

Other: Gait assessment

Interventions

Gait assessment OTHER

Gait assessment with wearable sensors

Healthy volunteers; Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Cognitive impairment interfering with task comprehension
• Cardiorespiratory instability or other contraindications to walking assessment

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Italy, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sandro Iannaccone, Neurologist

CONTACT

+390226435734; iannaccone.sandro@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Rehabilitation and Functional Recovery

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: March 16, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): January 8, 2028
• Study Completion (Estimated): January 8, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)