Gait Analysis Parameter and Upper Limb Evaluation in Control Participants

NCT07136506 | Recruiting

• 1 other identifier: ActiControl
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Keywords

Healthy Participants; Healthy Volunteers; Healthy Adults

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  5 recording periods of 3 weeks over 2 years

Secondary Outcomes (4)

• Device Acceptability and Adherence

  5 recording periods of 3 weeks over 2 years

• Reliability of Digital Variables

  5 recording periods of 3 weeks over 2 years

• Association with Demographic and Health Factors

  Over 2 years

• Group Differences in Digital Variables

  Over 2 years

Study Arms (1)

Control

EXPERIMENTAL

Device: Syde; Other: Post-recording questionnaire

Interventions

Syde DEVICE

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.

Control

Post-recording questionnaire OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Liege: lead
• Centre Hospitalier Régional de la Citadelle: collaborator
• SYSNAV: collaborator

Study Sites (1)

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

Liège, 4000, Belgium

RECRUITING

Study Officials

• Laurent Servais, MD

  Centre Hospitalier Universitaire de Liege

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Bovy

CONTACT

+3243218095; Nicolas.Bovy@citadelle.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Pediatrician

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 22, 2025
• Study Start: September 24, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)