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van CCT (UK)

van CCT (UK)

Sensor Validity

- candidate number25668
- NTR NumberNTR6341
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-dec-2016
- Secondary IDsMETC 2016.323 University Medical Center Groningen
- Public TitleSensor Validity
- Scientific TitleValidity and feasibility of a temperature sensor for long-term adherence monitoring in orthopedic footwear
- hypothesisAsses the validity and feasibility of a temperature sensor for adherence monitoring in orthopedic footwear
- Healt Condition(s) or Problem(s) studiedHealthy subjects
- Inclusion criteriahealthy individual
shoe size between 37 and 45
in possession of a shoe with shoe laces
- Exclusion criterian.a.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-aug-2016
- planned closingdate1-jan-2017
- Target number of participants10
- Interventionsn.a
- Primary outcomeuse of footwear in hours per day based on sensor
use of footwear in hours per day based on camera
- Secondary outcomen.a.
- Timepointsfootwear use was determined over a period of 48 hours with both sensor and camera
- Trial web site
- statusstopped
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
OntwikkelingsFonds voor Orthopedisch Maatschoen-technisch bedrijf (OFOM)
- Publications
- Brief summaryBACKGROUND: Orthopedic footwear is frequently prescribed to a wide variety of patients. Adherence of use of orthopedic footwear is a prerequisite of their effectiveness, but has mostly been assessed using methods, like questionnaires, interviews or diaries, with poor accuracy and reliability. A recent study has shown that temperature can be used to assess orthopedic footwear adherence, however, the sensor used could only collect data over a short period of time and had relatively large dimensions. A new technology is available, comprising a temperature sensor that is small and capable of long-term data collection (>100 days).

AIM: To assess the validity and feasibility of a new temperature sensor for measuring footwear use and nonuse in healthy individuals.

METHOD: In ten healthy volunteers, the validity of a new temperature sensor to discriminate between time periods of use and nonuse of footwear over a period of 48 hours was assessed. Footwear use measured with the sensor was compared to footwear use measured with a 1-minute time-lapse sports camera secured to the shoelace and focused on the lower leg. The correlation coefficient between footwear use based on the sensor and camera was calculated. The ease of the installation of the sensor in the insole and the data collection and analysis were assessed as feasibility criteria.

RESULTS: Mean footwear use measured with the camera was 8.10 (2.46) hours per day, and measured with the sensor 8.16 (2.37) hours per day. There was a strong correlation between footwear use assessed by camera and by sensor, r = 0.995.

DISCUSSION & CONCLUSION: The temperature sensor is valid and feasible for adherence monitoring in (orthopedic) footwear. The installation of the sensor, in the insole of the subjects' preferred footwear, and the data collection were performed easily.
- Main changes (audit trail)
- RECORD19-dec-2016 - 1-jun-2017

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