RecruitingNot ApplicableNCT07136506

Gait Analysis Parameter and Upper Limb Evaluation in Control Participants


Sponsor

Centre Hospitalier Universitaire de Liege

Enrollment

200 participants

Start Date

Sep 24, 2025

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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)
  • Participants with a reported BMI ≥17 and ≤30
  • Participant willing and able to comply with all study procedures

Exclusion Criteria6

  • 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

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Interventions

DEVICESyde

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.

OTHERPost-recording questionnaire

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.


Locations(1)

Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle

Liège, Belgium

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NCT07136506


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