Efficacy of live feedback to improve objectively monitored compliance to prescribed, home-based, exercise therapy-dosage in 15 to 19 year old adolescents with patellofemoral pain- a study protocol of a randomized controlled superiority trial (The XRCISE-AS-INSTRUcted-1 trial)

实时反馈对提高 15 至 19 岁髌股关节疼痛青少年对处方家庭运动疗法剂量的客观监测依从性的有效性——一项随机对照优效性试验的研究方案(XRCISE-AS-INSTRUcted-1 试验)

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Abstract

BACKGROUND: Patellofemoral pain is one of the most frequent knee conditions among adolescents with a prevalence of 7 %. Evidence-based treatment consists of patient education combined with hip and quadriceps strengthening. Recent evidence suggests that a large proportion of adolescents does not follow their exercise prescription, performing too few repetitions or too fast below the prescribed time under tension. Live feedback, such as a metronome or exercise games, has previously shown promising results in improving the quality of exercises. The aim of this study is to investigate if live feedback from a sensor (BandCizer™) and an iPad will improve the ability of adolescents with PFP to perform exercises as prescribed. METHODS: This study is a randomized, controlled, participant-blinded, superiority trial with a 2-group parallel design. Forty 15 to 19 year old adolescents with patellofemoral pain will be randomized to receive either live visual and auditory feedback on time under tension or no feedback on time under tension during a 6-week intervention period. Adolescents will be instructed to perform three elastic band exercises. Feedback will be provided by BandCizer™ and an iPad. The adolescents perform the exercises twice a week unsupervised and once a week during a supervised group training session. The primary outcome will be the mean deviation of the prescribed time under tension per repetition in seconds during the course of the intervention. DISCUSSION: Low compliance is a major problem among adolescents with patellofemoral pain. Providing the adolescents with real time feedback on time under tension from a sensor and an iPad could potentially help the adolescents perform the exercises as prescribed. This may increase the total exercise dosage they receive during treatment which may help improve patient outcomes. TRIAL REGISTRATION: Registered at ClinicalTrials.gov (identifier: NCT02674841 ) on February 4(th) 2016.

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