Fall risk prevention
Conditions
Interventions
Group 1: At each site, 24 participants are to be enrolled in the study: 24 healthy control subjects, 24 individuals with a chronic or acute peripheral or central vestibular disorder, and 24 patients w
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: Preserved independent walking ability (including with the use of aids such as walkers or canes) and sufficient proficiency in the German language.
Exclusion criteria
Exclusion criteria: Paresis or movement limitations of the lower extremities, amputations of the lower limbs, presence of total hip or knee prostheses, advanced neurodegenerative diseases affecting the motor system/ataxia (e.g., multiple sclerosis, Parkinson’s disease, Huntington’s chorea). Lack of capacity to provide consent or presence of legal guardianship.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints are: - successful establishment of a data pathway - successful establishment of real-time or near-real time data export from smart devices with a maximum latency of less than or equal to six hours. - successful establishment of integrated data collection combining digital motion markers and electronic clinical report forms to determine relevant parameters and identify candidate digital motion markers | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: - Evaluation of user experience and acceptance of the devices by study participants. - Development of a pathway toward the diagnostic application of smartwatches. - Assessment of the durability and usability of the smart devices under study conditions. - Determination of the number of complete datasets. - Determination of the duration of uninterrupted data recording per patient. - Assessment of data quality (completeness, duration, number of measurement points). - Percentage of the target data captured that are stored on the UKB servers. - Time from data acquisition to data availability on the UKB servers. - Process times from study consent to data availability for storage and analysis. - Determination and identification of usable/actionable digital motion biomarkers. - Provision of insights for differentiated analysis and identification of distinct demographic and clinical (risk) groups. | — |
Countries
Germany
Contacts
Public ContactMartin Möckel
Charité - Universitätsmedizin Berlin
Outcome results
None listed