Quantifying Gait Disorders With Wearable Sensors
ConditionGait Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorIRCCS San Raffaele
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Cognitive impairment interfering with task comprehension
Cardiorespiratory instability or other contraindications to walking assessment
Trial 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
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Gait assessment
Other interventionGait assessment with wearable sensors
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Patients1 intervention
Group B: Healthy volunteers1 intervention
Trial outcomes
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.
Time frame
Baseline (single time point)Secondary outcomes
1
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.
Time frame
Baseline (single time point)Sponsors and contacts
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Source ClinicalTrials.gov