Healthy ParticipantsActiControlNCT07136506
Gait Analysis Parameter and Upper Limb Evaluation in Control Participants
A study testing Syde and Post-recording questionnaire in people with Healthy Participants, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
Trial summary
The ActiControl study is a monocentric, academic, and fully remote observational study designed to build a normative, longitudinal dataset using the Syde® wearable device. The study will enroll 200 healthy volunteers across all age groups, genders, and backgrounds. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Syde and Post-recording questionnaire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Sep 2025to Dec 2028
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female of different age groups
- Signed informed consent form by participant him/herself or, in case of patients <18 years old, signed informed consent form by patient's parents or legal guardians
- Able to ambulate (minimum 10 meters without help)
- Participant willing and able to comply with all study procedures
Who cannot join
- Patients who have undergone a surgical procedure or who have experienced recent trauma (within fewer than 6 months) affecting the upper or lower limbs
- Elite athletes (at the national level)
- Pregnant women
- A chronic or acute muscular, neurological, infectious, or inflammatory pathology within the 3-week period immediately prior to inclusion
- An orthopedic, neuromuscular, or neurological pathology that affects the quality of the participant's walking gait
- No access to unlimited internet connection or alternatively no capacity to come on-site to upload Syde data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle
Liège, 4000
About this study
The ActiControl study is a monocentric, academic, and fully remote observational study designed to build a normative, longitudinal dataset using the Syde® wearable device. The study will enroll 200 healthy volunteers across all age groups, genders, and backgrounds. Participants will be remotely recruited and followed over two years, wearing the Syde® device for 3-week periods every 6 months. All study visits, including consent, data collection, and follow-up, are conducted remotely via phone or video conferencing. The primary objectives are to collect reference data on gait and movement patterns and to assess adherence and acceptability of the device. Secondary objectives include evaluating the reliability of digital endpoints and the influence of demographic and lifestyle factors on these measures.
Read the detailed description
Rare diseases, though individually uncommon, collectively affect approximately 5% of the European population, with many presenting neurological symptoms and significant societal burden. Clinical trials in this field face challenges such as small sample sizes and subjective outcome measures. To address these limitations, wearable technologies like Syde® and ActiMyo® have been developed to objectively quantify motor function using inertial sensors.
The Syde® device, worn on the wrist and ankle(s), continuously records upper- and lower-limb movements. One of its key metrics, the 95th percentile of stride velocity (SV95C), has been endorsed by the European Medicines Agency as a valid primary outcome in Duchenne Muscular Dystrophy (DMD) trials. Syde® has also been used in studies involving Spinal Muscular Atrophy (SMA), Angelman Syndrome, Facioscapulohumeral Muscular Dystrophy (FSHD), and other neurological conditions, as well as in healthy controls under 20 years old.
To further validate digital outcome measures, normative data across all age groups is essential. The ActiControl study will enroll 200 healthy volunteers (approximately 20 per decade from ages 0 to 90), ensuring balanced representation by gender, ethnicity, and socioeconomic status.
All study procedures are conducted remotely. Participants are recruited and enrolled electronically, including remote signing of the informed consent form. Demographic and health data (e.g., age, sex, height, weight) are collected via phone or video call at inclusion and every 6 months for 2 years. Participants will wear the Syde® device for 3 weeks at five timepoints (baseline, 6, 12, 18, and 24 months).
Primary objectives include:
Building a longitudinal dataset of Syde® digital variables. Assessing adherence and acceptability of the device across age groups.
Secondary objectives include:
Evaluating the reliability of Syde®-derived variables. Investigating the influence of demographic and lifestyle factors (e.g., age, gender, BMI, physical activity, seasonality) on digital endpoints.
Outcome measures include stride velocity, stride length, walking time, step asymmetry, stair climbing metrics, and more.
This study will contribute to the establishment of robust normative data, enabling more accurate interpretation of digital biomarkers in future clinical trials for rare and neurological diseases.
- Conditions
- Healthy Participants
- Being tested
- Syde, Post-recording questionnaire
- Keywords
- Healthy Participants, Healthy Volunteers, Healthy Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SydeDevice
Syde is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.
Post-recording questionnaireOther
The post-recording questionnaire aims at describing as much as possible the subject activity and quality of life during the recording period while being as low a burden as possible for the subject. The question formats are, on one hand, inspired by Quality of life and Physical Activity questionnaires usually used in Clinical Research and, on the other hand, based on device-specific needs for an optimal analysis. It covers fatigue status, physical status, physical activity with the Syde®, event(s) or condition(s) that may have impacted the ability to wear the Syde® during the recording.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Not described Receives: Device: Syde; Other: Post-recording questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital Mobility Monitoring Compliance
Measure of participant adherence to wearing the Syde® device using different parameters including total recording time, number of valid recording days (≥4 hours), and time to reach 50 and 180 hours of recording.
Measured: 5 recording periods of 3 weeks over 2 years
Walking Pattern Characteristics
Analysis of walking sequences, including maximal walking sequence duration, maximal distance walked in a single sequence, and maximal 30-minute walking distance.
Measured: 5 recording periods of 3 weeks over 2 years
Secondary outcomes (4)
Device Acceptability and Adherence
Measures of user engagement with the Syde® device across age groups and over time, including total recording time, valid days (≥5 hours), and time to reach 50 and 180 hours.
Measured: 5 recording periods of 3 weeks over 2 years
Reliability of Digital Variables
Test-retest reliability of Syde® digital variables assessed using intraclass correlation coefficients (ICC) between two consecutive half-periods.
Measured: 5 recording periods of 3 weeks over 2 years
Association with Demographic and Health Factors
Correlation of digital mobility outcomes with age, height, weight, BMI, and other demographic or health-related variables.
Measured: Over 2 years
Group Differences in Digital Variables
Comparison of digital mobility metrics across subgroups defined by gender, age, health status, education, socio-professional category, physical activity level, living environment, and seasonality.
Measured: Over 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start24 Sep 2025
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Régional de la Citadelle, SYSNAV
- Responsible party
- Principal investigator, Laurent Servais, Centre Hospitalier Universitaire de Liege
- Investigators
- Laurent Servais, MD, Principal investigator, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136506
- Sponsor's protocol ID
- ActiControl
- Acronym
- ActiControl
- Status last verified
- May 2026
- First submitted
- 7 Aug 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Analysis Parameter and Upper Limb Evaluation in Control Participants
- ClinicalTrials.gov ID
- NCT07136506
- Acronym / sponsor ID
- ActiControl / ActiControl
- Conditions
- Healthy Participants
- Keywords
- Healthy Participants, Healthy Volunteers, Healthy Adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de LiegeUniversity, hospital or other
- Collaborators
- Centre Hospitalier Régional de la Citadelle, SYSNAV
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Aug 2025 (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.
The ActiControl study is a monocentric, academic, and fully remote observational study designed to build a normative, longitudinal dataset using the Syde® wearable device. The study will enroll 200 healthy volunteers across all age groups, genders, and backgrounds. Participants will be remotely recruited and followed over two years, wearing the Syde® device for 3-week periods every 6 months. All study visits, including consent, data collection, and follow-up, are conducted remotely via phone or video conferencing. The primary objectives are to collect reference data on gait and movement patterns and to assess adherence and acceptability of the device. Secondary objectives include evaluating the reliability of digital endpoints and the influence of demographic and lifestyle factors on these measures.
Detailed description
Rare diseases, though individually uncommon, collectively affect approximately 5% of the European population, with many presenting neurological symptoms and significant societal burden. Clinical trials in this field face challenges such as small sample sizes and subjective outcome measures. To address these limitations, wearable technologies like Syde® and ActiMyo® have been developed to objectively quantify motor function using inertial sensors.
The Syde® device, worn on the wrist and ankle(s), continuously records upper- and lower-limb movements. One of its key metrics, the 95th percentile of stride velocity (SV95C), has been endorsed by the European Medicines Agency as a valid primary outcome in Duchenne Muscular Dystrophy (DMD) trials. Syde® has also been used in studies involving Spinal Muscular Atrophy (SMA), Angelman Syndrome, Facioscapulohumeral Muscular Dystrophy (FSHD), and other neurological conditions, as well as in healthy controls under 20 years old.
To further validate digital outcome measures, normative data across all age groups is essential. The ActiControl study will enroll 200 healthy volunteers (approximately 20 per decade from ages 0 to 90), ensuring balanced representation by gender, ethnicity, and socioeconomic status.
All study procedures are conducted remotely. Participants are recruited and enrolled electronically, including remote signing of the informed consent form. Demographic and health data (e.g., age, sex, height, weight) are collected via phone or video call at inclusion and every 6 months for 2 years. Participants will wear the Syde® device for 3 weeks at five timepoints (baseline, 6, 12, 18, and 24 months).
Primary objectives include:
Building a longitudinal dataset of Syde® digital variables. Assessing adherence and acceptability of the device across age groups.
Secondary objectives include:
Evaluating the reliability of Syde®-derived variables. Investigating the influence of demographic and lifestyle factors (e.g., age, gender, BMI, physical activity, seasonality) on digital endpoints.
Outcome measures include stride velocity, stride length, walking time, step asymmetry, stair climbing metrics, and more.
This study will contribute to the establishment of robust normative data, enabling more accurate interpretation of digital biomarkers in future clinical trials for rare and neurological diseases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Device: Syde, Other: Post-recording questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female of different age groups
- Signed informed consent form by participant him/herself or, in case of patients <18 years old, signed informed consent form by patient's parents or legal guardians
- Able to ambulate (minimum 10 meters without help)
- Participant willing and able to comply with all study procedures
Key exclusion criteria (6 listed)
- Patients who have undergone a surgical procedure or who have experienced recent trauma (within fewer than 6 months) affecting the upper or lower limbs
- Elite athletes (at the national level)
- Pregnant women
- A chronic or acute muscular, neurological, infectious, or inflammatory pathology within the 3-week period immediately prior to inclusion
- An orthopedic, neuromuscular, or neurological pathology that affects the quality of the participant's walking gait
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 |
|---|---|---|
| SydeSyde is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle. | Device | Control |
| Post-recording questionnaireThe post-recording questionnaire aims at describing as much as possible the subject activity and quality of life during the recording period while being as low a burden as possible for the subject. The question formats are, on one hand, inspired by Quality of life and Physical Activity questionnaires usually used in Clinical Research and, on the other hand, based on device-specific needs for an optimal analysis. It covers fatigue status, physical status, physical activity with the Syde®, event(s) or condition(s) that may have impacted the ability to wear the Syde® during the recording. | Other | Control |
Primary outcome
Digital Mobility Monitoring Compliance
Time frame: 5 recording periods of 3 weeks over 2 years
Measure of participant adherence to wearing the Syde® device using different parameters including total recording time, number of valid recording days (≥4 hours), and time to reach 50 and 180 hours of recording.
Walking Pattern Characteristics
Time frame: 5 recording periods of 3 weeks over 2 years
Analysis of walking sequences, including maximal walking sequence duration, maximal distance walked in a single sequence, and maximal 30-minute walking distance.
4 secondary outcomes
Device Acceptability and Adherence
Time frame: 5 recording periods of 3 weeks over 2 years
Reliability of Digital Variables
Time frame: 5 recording periods of 3 weeks over 2 years
Association with Demographic and Health Factors
Time frame: Over 2 years
Group Differences in Digital Variables
Time frame: Over 2 years
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 19 May 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.
Laurent Servais, MD principal investigator
Centre Hospitalier Universitaire de Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Syde and Post-recording questionnaire in people with Healthy Participants, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
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 4 inclusion and 6 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 19 May 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 Belgium. 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 Nicolas Bovy (+3243218095, Nicolas.Bovy@citadelle.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital Mobility Monitoring Compliance (time frame: 5 recording periods of 3 weeks over 2 years). The study lists 2 primary outcomes in all. 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 19 May 2026.