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NCT Number: NCT07473141

Quantifying Gait Disorders With 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).

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Key information

Conditions

Gait Disorders Mobility Limitation Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gait assessment

Other

Gait assessment with wearable sensors

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

    Time frame: Baseline (single time point)

    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.

Secondary outcomes

  1. Average of the normalized enveloped of surface electromyography signals

    Time frame: Baseline (single time point)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sandro Iannaccone, Neurologist

CONTACT

[email protected]

+390226435734

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 16, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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