Gait DisordersNCT07473141
Quantifying Gait Disorders With Wearable Sensors
An observational study of Gait Disorders, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait Disorders
- What is being tested?
- Gait assessment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 2 Mar 2026to 8 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Cognitive impairment interfering with task comprehension
- Cardiorespiratory instability or other contraindications to walking assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Sandro Iannaccone, +390226435734, iannaccone.sandro@hsr.it
About this study
Official title: Quantification of Gait Differences Between Healthy Volunteers and Patients Suffering From Gait Disorders Through 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).
Read more
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
- Being tested
- Gait assessment
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait assessmentOther
Gait assessment with wearable sensors
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Other: Gait assessment | |
| Healthy volunteers | Not described Receives: Other: Gait assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (single time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start2 Mar 2026
- Primary completion8 Jan 2028 (estimated)
- Study completion8 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandro Iannaccone, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473141
- Sponsor's protocol ID
- GAIT-01
- Status last verified
- Mar 2026
- First submitted
- 18 Feb 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Gait Differences Between Healthy Volunteers and Patients Suffering From Gait Disorders Through Wearable Sensors
- ClinicalTrials.gov ID
- NCT07473141
- Acronym / sponsor ID
- GAIT-01
- Conditions
- Gait Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 8 Jan 2028 (estimated)
- Study completion
- 8 Jan 2028 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Gait assessment |
| Healthy volunteers | – | Other: Gait assessment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Cognitive impairment interfering with task comprehension
- Cardiorespiratory instability or other contraindications to walking assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait assessmentGait assessment with wearable sensors | Other | Healthy volunteers, Patients |
Primary outcome
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.
1 secondary outcome
Average of the normalized enveloped of surface electromyography signals
Time frame: Baseline (single time point)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gait Disorders, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandro Iannaccone, Neurologist (+390226435734, iannaccone.sandro@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.