Status:
COMPLETED
Post-Operative Physical Activity Monitoring: Algorithm Performance and Clinical Outcomes
Lead Sponsor:
Alp Ozel
Collaborating Sponsors:
Analog Device, Inc.
Conditions:
Postoperative Period
Physical Activity
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this observational study is to validate physical activity algorithms in post-operative populations through raw accelerometer data collection using the ADI Study Watch 4.5 while in an in-pa...
Detailed Description
Participants After obtaining ethical approval, individuals meeting the inclusion criteria will be enrolled in the study at BAİBÜ Izzet Baysal Training and Research Hospital. After providing participan...
Eligibility Criteria
Inclusion
- Age ≥ 18, male or female
- ASA Score II - III
- Patients booked for a surgical procedure requiring general anesthesia care
- The subject has had a surgical procedure ≤3 days prior to data collection
- Expected duration of general anesthesia to be \> 1 hour
- Expected to be transferred to the PACU from the operating room
- Patients with an expected duration in the PACU ≥ 45 minutes
- Expected to be transferred from the PACU to an in-patient setting
- Must be able to understand and provide written consent
- Must be willing and able to comply with study procedures and duration
Exclusion
- The subject is unable or unwilling to provide written consent
- The subject is unable or unwilling to comply with the study and duration
- The subject has not yet recovered from the effects of anesthesia
- The subject requires the use of a wheel chair
- The subject has been diagnosed with a movement disorder such as Parkinson's disease, ataxia, dystonia, etc.
- The subject has not yet recovered from knee or hip surgery
- The subject has undergone orthopedic surgery within the last 2 years
- The subject has an injury, deformity, or abnormality at the sensor site that in the opinion of the investigators would interfere with the sensors' function
- The subject has any other condition, which in the opinion of the investigator would make them unsuitable for the study
- The subject is pregnant, lactating, or trying to get pregnant.
- Subjects with a history of severe contact allergies that may cause a reaction to standard adhesive materials found medical tape.
Key Trial Info
Start Date :
October 9 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 21 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06605066
Start Date
October 9 2024
End Date
July 21 2025
Last Update
July 24 2025
Active Locations (1)
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1
Bolu Abant Izzet Baysal University
Bolu, Turkey (Türkiye), 14030