Quantifying Gait Disorders With Wearable Sensors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gait assessment.
- Who it may be relevant to
- Registry conditions: Gait Disorders. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Quantification of Gait Differences Between Healthy Volunteers and Patients Suffering From Gait Disorders Through Wearable Sensors
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).
Interventions
- Other Gait assessment
Gait assessment with wearable sensors
Primary outcome measures
- 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)]
Secondary outcome measures (1)
- Average of the normalized enveloped of surface electromyography signals [Time frame: Baseline (single time point)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Ospedale San Raffaele — Milan
Identifiers
NCT: NCT07473141 · GAIT-01