Healthy Adults
Conditions
Brief summary
The study aims to constitute a longitudinal Syde® digital health technology (DHT) dataset to serve as a healthy adult reference for Syde® digital variables development and validation. Subjects will be assessed every 6 months for 2 years.
Interventions
None listed
Sponsors
SYSNAV
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Inclusion criteria
* Male or female aged between 18 and 65 years old * Signed informed consent * Subjects with a reported BMI ≥ 17 and ≤ 35 * Subject with unlimited internet connection at home and authorizing automatic data upload * Subject willing and able to comply with all study procedures including: * baseline data and questionnaires data entry on EDC (electronic data capture) throughout the study * Syde® related procedures * Subject confirming to be affiliated to, or beneficiary from, a social security category
Exclusion criteria
* Elite athletes (at a national level) * Pregnant women * Presence of an orthopedic, neuromuscular, or neurological pathology affecting walking gait quality or requiring a walking aid * Subjects reporting to have an incapacity or invalidity or to be affected by a chronic disease which can affect their activity and/or their lower limb function * Subjects reporting to have undergone recent surgical procedures, trauma (within 6 months), or affected by a disease or condition affecting lower limb function within 3 weeks before their inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Longitudinal change of SV95C (stride velocity 95th centile) | 2 years | Change of SV95C between baseline and Month 6, Month 12, Month 18 and Month 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess the transversal adherence of the Syde® device in healthy adults | Baseline | * Number of subjects reaching the defined threshold of recording hours during the protocol defined period at baseline * Number of days necessary to reach the defined threshold of recording hours at baseline during the protocol defined period at baseline |
| Assess the transversal acceptability of the Syde® device in healthy adults | Baseline | Usability score at baseline |
| Assess the longitudinal adherence of the Syde® device in healthy adults | 2 years | * Change in number of subjects reaching the defined threshold of recording hours during the protocol defined periods between baseline and Month 6, Month 12, Month 18, Month 24 * Change in number of days necessary to reach the defined threshold of recording during the protocol defined periods between baseline and Month 6, Month12, Month 18, Month 24 |
| Assess the longitudinal acceptability of the Syde® device in healthy adults | 2 years | Change in usability score between baseline and Month 24 |
| Assess the reliability of Syde® in healthy adults | 2 years | Reproducibility assessed by ICC (Intra-Class Correlation) and Bland and Altman analysis at each timepoint |
| Evaluate in this healthy adult cohort the transversal effect on Syde® digital endpoints of gender | Baseline | Correlation between Syde® derived endpoints and gender. The Syde® derived endpoints will include the SV95C (stride velocity 95th centile). |
| Evaluate in this healthy adult cohorts the transversal effect on Syde® digital endpoints of age | Baseline | Correlation between Syde® derived endpoints and age. The Syde® derived endpoints will include the SV95C (stride velocity 95th centile) . |
| Evaluate in this healthy adult cohorts the transversal effect on Syde® digital endpoints of BMI | Baseline | Correlation between Syde® derived endpoints and BMI. The Syde® derived endpoints will include the SV95C (stride velocity 95th centile) . |
| Investigate the relationship between changes in Syde® derived endpoints and changes in age | Month 6, Month 12, Month 18, Month 24 | Comparison between changes in Syde® derived endpoints and changes in age between baseline and Month 6, Month 12, Month 18 and Month 24. |
| Investigate the relationship between changes in Syde® derived endpoints and changes in BMI | Month 6, Month 12, Month 18, Month 24 | Comparison between changes in Syde® derived endpoints and changes in BMI between baseline and Month 6, Month 12, Month 18 and Month 24. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORShotaro Tachibana
Hospices Civils de Lyon - Hôpital Femme Mère Enfant (HFME)
Outcome results
None listed