Mobile Health to Improve Adherence and Patient Experience in Heart Transplantation Recipients: The mHeart Trial

Non-adherence after heart transplantation (HTx) is a significant problem. The main objective of this study was to evaluate if a mHealth strategy is more effective than standard care in improving adherence and patients’ experience in heart transplant recipients. Methods: This was a single-center, randomized controlled trial (RCT) in adult recipients >1.5 years post-HTx. Participants were randomized to standard care (control group) or to the mHeart Strategy (intervention group). For patients randomized to the mHeart strategy, multifaceted theory-based interventions were provided during the study period to optimize therapy management using the mHeart mobile application. Patient experience regarding their medication regimens were evaluated in a face-to-face interview. Medication adherence was assessed by performing self-reported questionnaires. A composite adherence score that included the SMAQ questionnaire, the coefficient of variation of drug levels and missing visits was also reported. Results: A total of 134 HTx recipients were randomized (intervention N = 71; control N = 63). Mean follow-up was 1.6 (SD 0.6) years. Improvement in adherence from baseline was significantly higher in the intervention group versus the control group according to the SMAQ questionnaire (85% vs. 46%, OR = 6.7 (2.9; 15.8), p-value < 0.001) and the composite score (51% vs. 23%, OR = 0.3 (0.1; 0.6), p-value = 0.001). Patients’ experiences with their drug therapy including knowledge of their medication timing intakes (p-value = 0.019) and the drug indications or uses that they remembered (p-value = 0.003) significantly improved in the intervention versus the control group. Conclusions: In our study, the mHealth-based strategy significantly improved adherence and patient beliefs regarding their medication regimens among the HTx population. The mHeart mobile application was used as a feasible tool for providing long-term, tailor-made interventions to HTx recipients to improve the goals assessed.

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Impact of a mobile application for tracking nausea and vomiting during pregnancy (NVP) on NVP symptoms, quality of life, and decisional conflicts regarding NVP treatments: the MinSafeStart randomized controlled trial (Preprint)

10.2196/preprints.36226 ◽

2022 ◽

Author(s):

Elin Ngo ◽

Maria Bich-Thuy Truong ◽

Hedvig Nordeng ◽

David Wright

Keyword(s):

Quality Of Life ◽

Pregnant Women ◽

Maternal Care ◽

Mobile Application ◽

Standard Care ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled

BACKGROUND Pregnant women are active users of mobile applications (app) for health purposes. These apps may improve self-management of health-related conditions. Up to 70% of pregnant women experience nausea and vomiting (NVP). Even mild NVP can significantly reduce the quality of life (QoL), and it can become an economic burden for both the woman and society. NVP often occurs before the first maternal care visit; therefore, apps can potentially play an important role in empowering pregnant women to recognize, manage, and seek appropriate treatment for NVP, when required. OBJECTIVE This study investigated whether the MinSafeStart mobile application (MSS app) could impact NVP-related symptoms, QoL, and decisional conflicts regarding NVP treatment. METHODS This randomized controlled trial enrolled 222 pregnant women with NVP in Norway from 2019-2020. The intervention group had access to the MSS app, which could be used to track NVP symptoms and access tailored advice. NVP severity was rated with the Pregnancy Unique Quantification of Emesis (PUQE) score. The control group followed standard maternal care. We collected data on maternal baseline characteristics, NVP severity, QoL, and decisional conflicts with two sets of online questionnaires. One set of questionnaires was completed at enrollment, and the other was completed after two weeks. We performed linear regression analyses to explore whether the use of the MSS app was associated with NVP severity, QoL, or decisional conflicts. RESULTS Among the 222 women enrolled in the study, 192 (86.5%) completed the baseline questionnaires and were randomized to either the intervention (n=89) or the control group (n=103). In the intervention group, 88 women downloaded the app, and 468 logs were recorded. In both groups, women were enrolled at a median of 8 gestational weeks. At baseline, the average PUQE scores were 4.9 and 4.7; the average QoL scores were 146 and 149; and the average decisional conflict scores were 40 and 43, in the intervention and control groups, respectively. The app had no impact on NVP severity (aβ: 0.6, 95% Cl: -0.1, 1.2), QoL (aβ: -5.3; 95% Cl: -12.5, 1.9), or decisional conflicts regarding NVP treatment (aβ: -1.1, 95% Cl -6.2, 4.2), compared to standard care. CONCLUSIONS Tracking NVP symptoms with the MSS app was not associated with improvements in NVP symptoms, QoL, or decisional conflicts after two weeks, compared to standard care. Future studies should include a process evaluation to improve our understanding of how pregnant women use the app and how to optimize its utility within maternity care. Specifically, studies should focus on how digital tools might facilitate counseling and communication between pregnant women and health care providers, regarding NVP management during pregnancy. CLINICALTRIAL This trial was registered at ClinicalTrails.gov (identifier: NCT04719286, registration date: January 22, 2021).

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A patient-centered mobile intervention to promote self-management and improve patient outcomes in chronic heart failure: The ManageHF4Life trial (Preprint)

10.2196/preprints.26185 ◽

2020 ◽

Author(s):

Michael P. Dorsch ◽

Karen B. Farris ◽

Brigid E. Rowell ◽

Scott L. Hummel ◽

Todd M. Koelling

Keyword(s):

Heart Failure ◽

Mobile Application ◽

Controlled Trial ◽

Intervention Group ◽

Self Care ◽

Self Management ◽

Control Group ◽

Patient Centered ◽

Self Monitoring ◽

Heart Failure Questionnaire

BACKGROUND Successful management of heart failure (HF) involves guideline based medical therapy as well as self-care behavior. As a result, the management of HF is moving toward a proactive real-time technological model of assisting patients with monitoring and self-management. OBJECTIVE Evaluate the effectiveness of a mobile application intervention that enhances self-monitoring on health-related quality of life, self-management, and reduces HF readmissions. METHODS A single-center randomized controlled trial was performed. Patients greater than 45 years of age and admitted for acute decompensated HF or recently discharged in the past 4 weeks were included. The intervention group used a mobile application (App). The intervention prompted daily self-monitoring and promoted self-management. The control group (No App) received usual care. The primary outcome was the change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) from baseline to 6 and 12 weeks. Secondary outcomes were the Self-Care Heart Failure Index (SCHFI) questionnaire and recurrent HF admissions. RESULTS Eighty-three patients were enrolled and completed all baseline assessments. Baseline characteristics were similar between groups with the exception of HF etiology. The App group had a reduced MLHFQ at 6 weeks (37.5 ± 3.5 vs. 48.2 ± 3.7, P=0.039) but not at 12 weeks (44.2 ± 4 vs. 45.9 ± 4, P=0.778) compared to No App. There was no effect of the App on the SCHFI at 6 or 12 weeks. The time to first HF admission was not statistically different between the App versus No App groups (HR 0.89, 95% CI 0.39-2.02, P=0.781) over 12 weeks. CONCLUSIONS The mobile application intervention improved MLHFQ at 6 weeks, but did not sustain its effects at 12 weeks. No effect was seen on HF self-care. Further research is needed to enhance engagement in the application for a longer period of time and to determine if the application can reduce HF admissions in a larger study. CLINICALTRIAL NCT03149510

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Impact of a 12-month web and smartphone-based intervention initiated during spa therapy to improve long-term physical activity of patients with chronic diseases: randomized controlled trial. (Preprint)

10.2196/preprints.29640 ◽

2021 ◽

Author(s):

Florie FILLOL ◽

Ludivine PARIS ◽

Sébastien PASCAL ◽

Aurélien MULLIEZ ◽

Christian-François ROQUES ◽

...

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Waist Circumference ◽

Controlled Trial ◽

Intervention Group ◽

Group Versus ◽

Control Group ◽

Spa Therapy

BACKGROUND Lack of physical activity (PA) and sedentary behaviors are leading risk factors for non-communicable diseases (NCD). Web-based interventions are effective in increasing PA in older adults and in NCD patients. In many countries a course of spa therapy is commonly prescribed to NCD patients and represents an ideal context to initiating lifestyle changes. OBJECTIVE The main objective of this study was to evaluate in NCD patients the effectiveness of an intervention combining an individual face-to-face coaching during spa therapy and, when returning home, a web- and smartphone-based PA program including a connected wrist pedometer and a connected weighing scale, on the achievement of physical activity guidelines (PAG) 12 months after the end of spa therapy. METHODS This was a 12-month, prospective, parallel-group, randomized controlled trial. Patients were enrolled during spa therapy and randomized 1:1 to intervention or control group who received usual advices about PA. From the end of spa therapy, PA, weight, waist circumference, and quality of life of the participants in both groups, were assessed by phone every 2 months. Primary outcome was meeting PAG (PA≥600 METs) at 12 months after the end of spa therapy. Secondary outcomes were: meeting current PAG at 6 months of follow-up; sedentary time, weight and waist circumference, PA and quality of life, at 6 and 12 months. Objective use data of the web-and smartphone-based PA program were collected. Analytic methods include intention-to-treat and constrained longitudinal data analyses. RESULTS The study sample was 228 patients (female : 77.2% (176/228), mean age: 62.4 years (SD 6.7), retired: 53.9% (123/228), mean BMI = 28.2 kg.m-2 (SD 4.2)). No group differences were found for any baseline variable. At 12 months, the proportion of patients achieving PAG was significantly higher in intervention group versus control group (81% vs 67% respectively, OR = 2.34 (95% CI 1.02- 5.38; P=.045). No difference between intervention and control group was found neither in achieving PAG at 6 months nor for sedentary time, weight and waist circumference, at 6 and 12 months. Regarding quality of life, the physical component subscale score was significantly higher at 12 months in intervention group versus control group (mean difference: 4.1 (95% CI 1.9-6.3; P<.001). The mean duration use of the program was 7.1 months (SD 4.5). Attrition rate during the first 2 months of the program was 20.4% (23/113) whereas 39.8% (45/113) of the participants used the program for at least 10 months. CONCLUSIONS The results showed significantly more participants meeting PAG at one year in the intervention group compared to controls. A course of spa therapy offers the ideal time and setting to implement education in PA. Digital coaching seems to be more efficient than usual coaching for increasing the level of PA and decreasing sedentariness on the long term. CLINICALTRIAL ClinicalTrials.gov NCT02694796; https://clinicaltrials.gov/ct2/show/NCT02694796.

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Effect of a breastfeeding educational intervention: a randomized controlled trial

Revista Latino-Americana de Enfermagem ◽

10.1590/1518-8345.3081.3335 ◽

2020 ◽

Vol 28 ◽

Author(s):

Erdnaxela Fernandes do Carmo Souza ◽

Alfredo Almeida Pina-Oliveira ◽

Antonieta Keiko Kakuda Shimo

Keyword(s):

Randomized Controlled Trial ◽

Educational Intervention ◽

Exclusive Breastfeeding ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

P Value ◽

Postpartum Women ◽

Significance Level ◽

Randomized Controlled

Objective: to assess the effect of a breastfeeding educational intervention on the counseling provided to postpartum women. Method: this is a randomized controlled trial including 104 postpartum women (intervention group = 52 and control group = 52) from a private hospital, whose educational intervention was based on the pragmatic theory and on the use of a soft-hard technology called Breastfeeding Educational Kit (Kit Educativo para Aleitamento Materno, KEAM). Women were followed-up for up to 60 days after childbirth. Chi-Squared Test, Fischer’s Exact Test, and Generalized Estimating Equation were used, with a significance level of 5% (p-value <0.05). The analyses were performed using the Statistical Package for the Social Sciences, version 24. Results: the postpartum women in the intervention group had fewer breastfeeding difficulties and a higher percentage of exclusive breastfeeding at all time points compared with those in the control group. Conclusion: the educational intervention based on active methodologies and stimulating instructional resources was effective in developing greater practical mastery among postpartum women with regard to adherence and maintenance of exclusive breastfeeding. Registry REBEC RBR – 8p9v7v.

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Evaluating the effects of a mindfulness mobile application on student pharmacists’ stress, burnout, and mindfulness

American Journal of Health-System Pharmacy ◽

10.1093/ajhp/zxab467 ◽

2021 ◽

Author(s):

Angela Chu ◽

Tyler M Rose ◽

Danielle A Gundrum ◽

Tressa E McMorris ◽

Eytan A Klausner ◽

...

Keyword(s):

Mobile Application ◽

Controlled Trial ◽

Intervention Group ◽

Secondary Outcome ◽

Control Group ◽

Intervention Period ◽

Entire Study ◽

Positive Effects ◽

Waitlist Control Group

Abstract Disclaimer In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose Pharmacists report high levels of burnout. Mindfulness approaches have been demonstrated to have positive results in the general population and in other healthcare professions. However, limited studies have been performed evaluating mindfulness approaches in student pharmacists. The aim of this study was to evaluate the effectiveness of daily use of a mindfulness mobile application in improving student pharmacists’ perceived stress, burnout, and mindfulness. Methods This study was a randomized, longitudinal, waitlist-controlled trial. The intervention group was asked to meditate using the mindfulness application Headspace daily for at least 6 weeks. The waitlist control group was asked to abstain from using the application for the entire study. Stress, burnout, and mindfulness were assessed using validated survey instruments at baseline, 6 weeks, and 10 weeks. A secondary outcome was to assess the persistence of application use after the intervention period. Results Fifty-six participants completed the study. The intervention group reported significantly lower scores on stress and burnout at 6 weeks compared to the control group. The intervention group also reported significantly higher scores on mindfulness. The differences in stress, burnout, and mindfulness persisted at follow-up. The mean percentage of students in the intervention group who used the application each day was 90% over the intervention period and 62% over the follow-up period. Conclusion A mindfulness mobile application significantly improved student pharmacists’ stress, burnout, and mindfulness with daily use. Most participants continued to use the application for 4 weeks after the end of the intervention. Positive effects on stress and mindfulness persisted even with decreased use.

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User-driven design of child restraint information to reduce errors in use: a pilot randomised controlled trial

Injury Prevention ◽

10.1136/injuryprev-2019-043380 ◽

2019 ◽

Vol 26 (5) ◽

pp. 432-438 ◽

Cited By ~ 2

Author(s):

Alexandra B Hall ◽

Catherine Ho ◽

Bianca Albanese ◽

Lisa Keay ◽

Kate Hunter ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Instructional Materials ◽

Control Group ◽

P Value ◽

Point Increase ◽

Comprehension Score ◽

Child Restraint ◽

Randomised Controlled

BackgroundIncorrect use of child restraints is a long-standing problem that increases the risk of injury in crashes. We used user-centred design to develop prototype child restraint instructional materials. The objective of this study was to evaluate these materials in terms of comprehension and errors in the use of child restraints. The relationship between comprehension and errors in use was also explored.MethodsWe used a parallel-group randomised controlled trial in a laboratory setting. The intervention group (n=22) were provided with prototype materials and the control group (n=22) with existing instructional materials for the same restraint. Participants installed the restraint in a vehicle buck, secured an appropriately sized mannequin in the restraint and underwent a comprehension test. Our primary outcome was overall correct use, and our secondary outcomes were (1) comprehension score and (2) percent errors in the installation trial.ResultsThere was 27% more overall correct use (p=0.042) and a higher mean comprehension score in the intervention group (mean 17, 95% CI 16 to 18) compared with the control group (mean 12, 95% CI 10 to 14, p<0.001). The mean error percentage in the control group was 23% (95% CI 16% to 31%) compared with 14% in the intervention group (95% CI 8% to 20%, p=0.056). For every one point increase in comprehension, there was an almost 2% (95% CI −2.7% to −1.0%) reduction in errors (y=45.5–1.87x, p value for slope <0.001).ConclusionsConsumer-driven design of informational materials can increase the correct use of child restraints. Targeting improved comprehension of informational materials may be an effective mechanism for reducing child restraint misuse.

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A comparison of hydrophobic polyurethane and polyurethane peripherally inserted central catheter: results from a feasibility randomized controlled trial

Trials ◽

10.1186/s13063-020-04699-z ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Nicole C. Gavin ◽

Tricia M. Kleidon ◽

Emily Larsen ◽

Catherine O’Brien ◽

Amanda Ullman ◽

...

Keyword(s):

Standard Care ◽

Dwell Time ◽

Controlled Trial ◽

Intervention Group ◽

Trial Registration ◽

Care Group ◽

Control Group ◽

Peripherally Inserted Central Catheter ◽

Central Catheter ◽

Efficacy Trial

Abstract Background To evaluate the feasibility of an efficacy trial comparing a hydrophobic polyurethane peripherally inserted central catheter (PICC) with a standard polyurethane PICC. Methods This pilot randomised controlled trial (RCT) was conducted between May 2017 and February 2018. Adult participants (n = 111) were assigned to hydrophobic polyurethane PICC with proximal valve (intervention) or a polyurethane PICC with external clamp (standard care). Primary outcome was trial feasibility including PICC failure. Secondary outcomes were central line-associated bloodstream infection, local infection, occlusion, thrombosis, fracture and dislodgement, phlebitis, local or systemic allergic reaction, and PICC dwell time. Results All feasibility outcomes were achieved, apart from eligibility criteria. In total, 338 patients were screened, 138 were eligible (41%), and of these 111 were randomised (80%). Patients received the allocated PICC in 106 (95%) insertions. No patients withdrew from the study and there was no missing data. PICC failure was 24% (13/55) in the intervention group and 22% (12/55) in the standard care group (p = 0.820). PICC failure per 1000 PICC days was 16.3 in the intervention group and 18.4 in the control group (p = 0.755). The average dwell time was 12 days in the intervention and 8 days in the control group. Conclusions This study demonstrates the feasibility of an efficacy trial of PICC materials in an adult population, once adjustments were made to include not only in-patients, but also patients being discharged to the Hospital in the Home service. Trial registration Australia and New Zealand Clinical Trials Registry ACTRN12616001578493. Prospectively registered on 16 November 2016. The trial protocol was published a priori (Kleidon et al., Vasc Access 3:15–21, 2017).

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Atorvastatin in Helicobacter Pylori Treatment: A Randomized Controlled Trial and Review

10.21203/rs.3.rs-575317/v1 ◽

2021 ◽

Author(s):

Mohammad Reza Mohammad Hoseini Azar ◽

Parham Porteghali ◽

Amin Sedokani

Keyword(s):

Helicobacter Pylori ◽

Standard Treatment ◽

Controlled Trial ◽

Intervention Group ◽

Trial Registration ◽

Control Group ◽

P Value ◽

Bismuth Subcitrate ◽

Significant Difference ◽

H Pylori

Abstract Background: Considering the increase in drug resistance over time to Helicobacter pylori treatment relying on the anti-inflammatory and antibacterial effects of atorvastatin to increase the success rate of H. pylori eradication, we examined the effect of adding atorvastatin to standard treatment of H. pylori eradication.Results: A total of 186 symptomatic patients who had been diagnosed with Helicobacter pylori infection and tested for H. pylori eradication were examined by a pathological response or positive urea breath test. Patients who received atorvastatin in addition to standard treatment were also identified based on a table of random numbers. Standard treatment included a 240mg bismuth subcitrate tablet, a 40mg pantoprazole tablet, a 500mg metronidazole tablet, and 2 capsules of 500mg amoxicillin, all taken BID for 14 days. After 4 weeks of treatment, all patients underwent stool testing for H. pylori fecal antigen. If the test was positive, the request was considered a failure of treatment, and if the test was negative, it was considered a successful eradication of H. pylori. The clinical trial registration code for this study is IRCT20190823044589N1. The eradication rate of H. pylori was 80% in the control group and 80.9% in the intervention group, which did not show a statistically significant difference between the two groups (P-value=0.971).Conclusion: Adding atorvastatin to 4-drug regimen of PPI, bismuth subcitrate, amoxicillin, and metronidazole as the first line of treatment for H. pylori eradication is ineffective.Trial registration: IRCT, IRCT20190823044589N1. Registered 28 December 2019 - Retrospectively registered, https://en.irct.ir/trial/41734

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BCG vaccination impact on mortality and recovery rates in COVID-19: A meta-analysis

Monaldi Archives for Chest Disease ◽

10.4081/monaldi.2021.1875 ◽

2021 ◽

Author(s):

Surjit Singh ◽

Daisy Khera ◽

Ankita Chugh ◽

Sameer Khasbage ◽

Pushpinder S. Khera ◽

...

Keyword(s):

Mortality Rate ◽

Recovery Rate ◽

Meta Analysis ◽

Intervention Group ◽

Group Versus ◽

Pooled Analysis ◽

Control Group ◽

P Value ◽

Vaccination Policy ◽

Bcg Vaccination

COVID-19 is a pandemic caused by SARS-CoV-2 virus which is a very worrisome public health emergency. In this study, we compared the mortality rate and recovery rate in countries with and without BCG vaccination policy. The data of mortality of COVID-19 was extracted from worldometer (https://www.worldometers.info/coronavirus/) on 26th July 2020. The data of countries where BCG vaccination is being done for all individuals is taken from BCG world atlas (http://www.bcgatlas.org/index.php), updated in 2017. BCG vaccination policy recommended countries are intervention group versus countries without BCG vaccination policies which are regarded as control group. Pooled analysis of countries with and without BCG vaccination policy revealed mortality rate of 1.31% (95%CI – 1.31% to 1.32%; I2 = 100%, p<0.01) and 3.25% (95%CI – 3.23% to 3.26%; I2 = 100%, p<0.01), respectively. The recovery rate in two country groups were found to be 72.60% (95%CI – 72.57% to 72.63%) and 55.94% (95%CI – 55.90% to 55.98%), respectively. 52 individuals need to be BCG vaccinated to prevent one death (NNT = 52). In BCG vaccination program countries, there is statistically and clinically significant less mortality (p-value <0.001) as compared to countries without BCG policy. Our findings corroborate the hypothesis that BCG vaccination may provide protection from COVID-19. High quality evidence from randomised controlled trials are required to establish causality between BCG vaccination and protection from severe COVID-19.

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Effects of barefoot walking on the flat foot in school going children: A Randomised control trial

International Journal of Research in Pharmaceutical Sciences ◽

10.26452/ijrps.v11ispl4.4382 ◽

2020 ◽

Vol 11 (SPL4) ◽

pp. 1805-1812

Author(s):

Sharath Hullumani V ◽

Purusotham Chippala

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Well Being ◽

Randomised Control Trial ◽

Control Group ◽

P Value ◽

Foot And Ankle ◽

Flat Foot ◽

Study Results ◽

Arch Index

Flat foot is also called Plano-valgus foot, and it is a term, that is commonly used in describing flat foot. Some studies have suggested, that certain foot-specific exercises and barefoot weight bear walking can change foot function like flat foot, and also confirm that shoed walking children are more likely to get a flat foot. An Assessor blinded, Randomized controlled trial with thirty-eight children with flat foot aged 6 – 14 years, both male and female were randomised to the control group (n= 19) and intervention group (n=19). The control group had performed barefoot walking for 45 minutes a day for eight weeks, and the intervention group had received foot-specific exercises with barefoot walking for eight weeks. Foot posture was evaluated by the arch index, while the Oxford foot and ankle questionnaire was used to measure the subjective well-being of children. Measurements were taken before and after the eight weeks of intervention. The outcome of the randomised control trial showed that the barefoot walking group faired far better than that which didn't (p-value <0.05). The intervention group outcomes measure Arch Index, and Oxford Foot and Ankle Questionnaire were p-values is <0.05 from seventh and eight weeks. This study results suggest that barefoot walking and specific foot exercises are effective in improving the flat foot in school-going children.

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