Quantification of Gait Differences Between Healthy Volunteers and Patients Suffering From Gait Disorders Through Wearable Sensors
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 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
Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Patients
Intervention: Gait assessment (Other)
Healthy volunteers
Intervention: Gait assessment (Other)
Outcomes
Primary Outcomes
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
- Average of the normalized enveloped of surface electromyography signals(Baseline (single time point))
Investigators
Sandro Iannaccone
Director of Department of Rehabilitation and Functional Recovery
IRCCS San Raffaele