Physical Activity Tracking in Paediatric Elective Tonsillectomy
PATIPS
2 other identifiers
observational
24
1 country
1
Brief Summary
This pilot study will investigate the feasibility of physical activity tracking in patients aged 4-16 years before and after elective tonsillectomy as an innovative tool in paediatric research. The participating patients will receive a wearable physical activity tracker (CE-certified) that will continuously measure the patients' physical activity before and after an elective tonsillectomy, in addition to their parents' documentation of their child's activity in a conventional diary.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2017
CompletedFirst Posted
Study publicly available on registry
June 2, 2017
CompletedStudy Start
First participant enrolled
June 29, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedApril 22, 2019
April 1, 2019
11 months
May 30, 2017
April 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Feasibility of physical activity tracking in children
Difference in proportions of patients having complete activity measurement data, comparing the electronic tracker with the conventional diary.
up to 6 weeks
Study Arms (2)
Children aged 4-7 years
Children and adolescents aged 8-16 years
Eligibility Criteria
Children undergoing elective tonsillectomy or tonsillotomy
You may qualify if:
- Age 4 to 16 years old, in 2 subgroups (4-7 years, 8-16 years)
- Inpatient surgery at University Children's Hospital Basel (UKBB), Switzerland
- Children undergoing an elective tonsillectomy or tonsillotomy. Children having additional ENT procedures, such as adenectomy, tympanostomy, etc. may be included as well.
You may not qualify if:
- Children with mental or physical impairment during daily-life activities.
- Children undergoing additional surgical procedures other than Ear, Nose \& Throat (ENT) procedures impacting the recovery period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Children's Hospital Basel
Basel, Canton of Basel-City, 4056, Switzerland
Related Publications (1)
Lambrechtse P, Ziesenitz VC, Atkinson A, Bos EJ, Welzel T, Gilgen Y, Gurtler N, Heuscher S, Cohen AF, van den Anker JN. Monitoring the recovery time of children after tonsillectomy using commercial activity trackers. Eur J Pediatr. 2021 Feb;180(2):527-533. doi: 10.1007/s00431-020-03900-4. Epub 2021 Jan 4.
PMID: 33394138DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Victoria Ziesenitz, MD
University Children's Hospital Basel
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 30, 2017
First Posted
June 2, 2017
Study Start
June 29, 2017
Primary Completion
May 25, 2018
Study Completion
June 30, 2018
Last Updated
April 22, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share