- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01481324
Outcomes of Compliance With Brace Wear in Clubfoot
Measurement of Compliance in Clubfoot Bracing Via a Novel Pressure Sensor
It has been shown that compliance with brace wear can significantly improve the treatment outcome of idiopathic clubfoot deformities. Noncompliance rates have been estimated to be around 30-41% with initial orthosis wear after successful treatment with serial castings. These studies have depended on family logs and not objective data. With the development of a monitoring device, this study hopes to examine: (1) actual patient compliance, (2) comparisons of actual wear time and assumed wear time and (3) the relationship of patient wear with clinical outcomes.
Hypothesis:
Actual patient compliance in foot abduction orthoses (FAO) wear is less than self-reported compliance and noncompliance is correlated to future surgeries.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Kentucky
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Lexington, Kentucky, Forenede Stater, 40502
- Shriners Hospital for Children
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Unilateral or bilateral clubfoot
- Birth to 3 years of age
- Has been successfully treated with Ponseti casting protocol
Exclusion Criteria:
- Any other prior treatment for clubfoot
- Other existing diagnoses or conditions
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Functioning Pressure Sensor Group
This group will have a functioning pressure sensor placed on the foot ankle orthosis.
The group will be blinded as to whether or not the sensor is functioning.
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Non-Functioning Pressure Sensor Group
This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis.
The group will be blinded as to whether or not the sensor is functioning.
|
No Sensor Group
This group will not have a pressure sensor placed on the foot ankle orthosis.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours)
Tidsramme: 3 months
|
Number of hours per day in brace will be measured by pressure sensor at the end of month 1, month 2 and month 3. Parent report of brace wear will also be documented at each of these timepoints.
Wear rate percentage will be calculated by dividing the number of hours of brace wear (either actual as measured by the sensor or reported by parent diary) by the recommended 24 hours.
|
3 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Todd A Milbrandt, MD, Shriners Hospital for Children
Publikationer og nyttige links
Generelle publikationer
- Thacker MM, Scher DM, Sala DA, van Bosse HJ, Feldman DS, Lehman WB. Use of the foot abduction orthosis following Ponseti casts: is it essential? J Pediatr Orthop. 2005 Mar-Apr;25(2):225-8. doi: 10.1097/01.bpo.0000150814.56790.f9.
- Dobbs MB, Morcuende JA, Gurnett CA, Ponseti IV. Treatment of idiopathic clubfoot: an historical review. Iowa Orthop J. 2000;20:59-64.
- Dobbs MB, Rudzki JR, Purcell DB, Walton T, Porter KR, Gurnett CA. Factors predictive of outcome after use of the Ponseti method for the treatment of idiopathic clubfeet. J Bone Joint Surg Am. 2004 Jan;86(1):22-7. doi: 10.2106/00004623-200401000-00005.
- Haft GF, Walker CG, Crawford HA. Early clubfoot recurrence after use of the Ponseti method in a New Zealand population. J Bone Joint Surg Am. 2007 Mar;89(3):487-93. doi: 10.2106/JBJS.F.00169.
- Changulani M, Garg NK, Rajagopal TS, Bass A, Nayagam SN, Sampath J, Bruce CE. Treatment of idiopathic club foot using the Ponseti method. Initial experience. J Bone Joint Surg Br. 2006 Oct;88(10):1385-7. doi: 10.1302/0301-620X.88B10.17578.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SHC-Lex-101
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