Dataset Information

MHealth for the Monitoring of Brace Compliance and Wellbeing in Adolescents with Idiopathic Scoliosis: Study Protocol for a Feasibility Study.

ABSTRACT: Attempts to optimize monitoring of brace adherence prescribed to adolescents with idiopathic scoliosis (IS) have generally relied on sensors. Sensors, however, are intrusive and do not allow the assessment of psychological and physical consequences of brace use that might underlie poor adherence. Mobile applications have emerged as alternatives to monitor brace compliance. However, the feasibility and utility of these app-based systems to assess key psychological and physical domains associated with non-adherence remain unexplored. This feasibility study aims to test the usability, acceptability, and clinical utility of an app-based system that monitors brace use and related psychological and physical factors. Forty adolescents with IS daily respond to the app for 90 days. The patient responses may generate clinical alarms (e.g., brace non-adherence, discomfort, or distress) that will be sent daily to the medical team. Primary outcomes will be app usability, acceptability, and response rates. Secondary outcomes will include brace adherence, the number of side effects reported, number and type of clinical alarms, stress, quality of life, perceived health status, and mood. If accepted by patients and clinicians, apps may allow rapid detection and response to undesired events in adolescents undergoing brace treatment.

SUBMITTER: Martinez-Borba V

PROVIDER: S-EPMC8345733 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature

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mHealth for the Monitoring of Brace Compliance and Wellbeing in Adolescents with Idiopathic Scoliosis: Study Protocol for a Feasibility Study.

Martínez-Borba Verónica V Suso-Ribera Carlos C Díaz-García Amanda A Salat-Batlle Judith J Castilla Diana D Zaragoza Irene I García-Palacios Azucena A Sánchez-Raya Judit J

International journal of environmental research and public health 20210722 15

Attempts to optimize monitoring of brace adherence prescribed to adolescents with idiopathic scoliosis (IS) have generally relied on sensors. Sensors, however, are intrusive and do not allow the assessment of psychological and physical consequences of brace use that might underlie poor adherence. Mobile applications have emerged as alternatives to monitor brace compliance. However, the feasibility and utility of these app-based systems to assess key psychological and physical domains associated ...[more]

PMID: 34360060

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Project description:Over the last years, evidence has accumulated in support of bracing as an effective treatment option in patients with idiopathic scoliosis. Yet, little information is available on the impact of compliance on the outcome of conservative treatment in scoliotic subjects. The aim of the present study was to prospectively evaluate the association between compliance to brace treatment and the progression of scoliotic curve in patients with idiopathic adolescent (AIS) or juvenile scoliosis (JIS).Among 1.424 patients treated for idiopathic scoliosis, 645 were eligible for inclusion criteria. Three outcomes were distinguished in agreement with the SRS criteria: curve correction, curve stabilization and curve progression. Brace wearing was assessed by one orthopaedic surgeon (LA) and scored on a standardized form. Compliance to treatment was categorized as complete (brace worn as prescribed), incomplete A (brace removed for 1 month), incomplete B (brace removed for 2 months), incomplete C (brace removed during school hours), and incomplete D (brace worn overnight only). Chi square test, T test or ANOVA and ANOVA for repeated measures tests were used as statistical tests.The results from our study showed that at follow-up the compliance was: Complete 61.1%; Incomplete A 5.2%; Incomplete B 10.7%; Incomplete C 14.2%; Incomplete D 8.8%. Curve correction was accomplished in 301/319 of Complete, 19/27 Incomplete A, 25/56 Incomplete B, 52/74 Incomplete C, 27/46 Incomplete D. Cobb mean value was 29.8?±?7.5 SD at beginning and 17.1?±?10.9 SD at follow-up. Both Cobb and Perdriolle degree amelioration was significantly higher in patients with complete compliance over all other groups, both in juvenile, both in adolescent scoliosis. In the intention-to-treat analysis, the rate of surgical treatment was 2.1% among patients with definite outcome and 12.1% among those with drop-out. Treatment compliance showed significant interactions with time.Curve progression and referral to surgery are lower in patients with high brace compliance. Bracing discontinuation up to 1 month does not impact on the treatment outcome. Conversely, wearing the brace only overnight is associated with a high rate of curve progression.

Project description:BackgroundFour factors have been reported to affect brace treatment outcome: (1) growth or curve based risk, (2) the in-brace correction, (3) the brace wear quantity, and (4) the brace wear quality. The quality of brace design affects the in-brace correction and comfort which indirectly affects the brace wear quantity and quality. This paper reported the immediate benefits and results on using ultrasound (US) to aid orthotists to design braces for the treatment of scoliosis.MethodsThirty-four AIS subjects participated in this study with 17 (2 males, 15 females) in the control group and 17 (2 males, 15 females) in the intervention (US) group. All participants were prescribed full time TLSO, constructed by either of the 2 orthotists in fabrication of spinal braces. For the control group, the Providence brace design system was adopted to design full time braces. For the intervention group, the custom standing Providence brace design system, plus a medical ultrasound system, a custom pressure measurement system and an in-house software were used to assist brace casting.ResultsIn the control group, 8 of 17 (47%) subjects needed a total of 11 brace adjustments after initial fabrication requiring a total of 28 in-brace radiographs. Three subjects (18%) required a second adjustment. For the US group, only 1 subject (6%) required adjustment. The total number of in-brace radiographs was 18. The p value of the chi-square for requiring brace adjustment was 0.006 which was a statistically significant difference between the two groups. In the intervention group, the immediate in-brace correction as measured from radiographs was 48 ± 17%, and in the control group the first and second in-brace correction was 33 ± 19% and 40 ± 20%, respectively. The unpaired 2 sided Student's t test of the in-brace correction was significantly different between the US and the first follow-up of the control group (p = 0.02), but was not significant after the second brace adjustment (p = 0.22).ConclusionsThe use of the 3D ultrasound system provided a radiation-free method to determine the optimum pressure level and location to assist brace design, resulting in decreased radiation exposure during follow-up brace evaluation, increased the in-brace correction, reduced the patients' visits to both brace adjustment and scoliosis clinics. However, the final outcomes could not be reported yet as some of patients are still under brace treatment.Trial registrationNCT02996643, retrospectively registered in 16 December 2016.

Project description:PurposeBrace treatment for adolescent idiopathic scoliosis (AIS) is usually prescribed for 20-40° curves in patients with growth potential. The aim is to reduce the risk of curve progression during growth and to avoid the curve reaching a surgical threshold. Having as small a curve as possible at skeletal maturity will reduce the risk of curve progression during adult life. While evidence exists for brace treatment in AIS, there is disagreement on how and when to discontinue bracing. The purpose of this review was to investigate what criteria have been reported for initiating brace cessation and published weaning protocols and to look at estimates of the number of patients that may progress > 5 degrees after the end of growth.MethodsThis scoping review summarizes existing knowledge on the best time to stop bracing in AIS patients, how to "wean," and what happens to spinal curves after bracing. Searches were carried out through MEDLINE, EMBASE, and PsycINFO in April 2022. A total of 1936 articles were reduced to 43 by 3 reviewers. Full papers were obtained, and data were extracted.ResultsWeaning was most commonly determined by Risser 4 (girls) and 5 (boys). Other requirements included 2 years post-menarche and no growth in standing/sitting height for 6 months. Skeletal maturity assessed from hand and wrist radiographs, e.g., Sanders' stage; distal radius and ulnar physes, could determine the optimal weaning time to minimize curve progression. Complete discontinuation was the most common option at skeletal maturity; variations on weaning protocols involved gradual reduction of bracing over 6-12 months. Curve progression after weaning is common. The 12 studies reporting early curve progression after brace weaning found a mean Cobb angle progression of 3.8° (n = 1655). From the seven studies reporting early curve progression by > 5 degrees, there were 236/700 (34%) patients. There is limited information on risk factors to predict early curve progression after finishing brace treatment with larger curves, especially those over 40 degrees possibly having more chance of progression.ConclusionCurve progression after bracing cessation is a negative outcome for patients who have tolerated bracing for several years, especially if surgery is required. The literature shows that when to start brace cessation and weaning protocols vary. Approximately 34% of patients progressed by more than 5 degrees at 2-4 years after brace cessation or weaning. Larger curves seem more likely to progress. More research is needed to evaluate the risk factors for curve progression after brace treatment, defining the best time to stop bracing based on the lowest risk of curve progression and whether there is any benefit to weaning.

Dataset Information

MHealth for the Monitoring of Brace Compliance and Wellbeing in Adolescents with Idiopathic Scoliosis: Study Protocol for a Feasibility Study.

Publications

mHealth for the Monitoring of Brace Compliance and Wellbeing in Adolescents with Idiopathic Scoliosis: Study Protocol for a Feasibility Study.

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