Postural insoles on gait in children with cerebral palsy: Randomized controlled double-blind clinical trial

Neto, Hugo Pasin; Grecco, Luanda André Collange; Ferreira, Luis Alfredo Braun; Duarte, Natália de Almeida Carvalho; Galli, Manuela; Oliveira, Cláudia Santos

doi:10.1016/j.jbmt.2017.03.005

Cited by 8 publications

(16 citation statements)

References 27 publications

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“…No two trials used the same sham insole. Within these trials, 14 different conditions were investigated: Achilles tendinopathy, 21 cavus foot, 22 cerebral palsy, 23,24 diabetes, 25 flat foot, 26,27 foot osteoarthritis, 28 hemiparesis, 29 knee osteoarthritis, 30 back pain, [31][32][33] patellofemoral pain, 34 plantar fasciitis, [35][36][37][38][39] rheumatoid arthritis, [40][41][42] fractures. 43 Three studies included child participants, one which investigated flat feet 27 and two which investigated cerebral palsy.…”

Section: Resultsmentioning

confidence: 99%

“…43 Three studies included child participants, one which investigated flat feet 27 and two which investigated cerebral palsy. 23,24 The characteristics of the included studies are summarized in Table 2.…”

Section: Resultsmentioning

confidence: 99%

“…Of the three studies that included children, 23,24,27 two provided limited information on the construction of the sham insole. 23,24 Therefore, it was not possible to separately examine the construction of sham insoles for children.…”

Section: Risk Of Bias Assessmentmentioning

confidence: 99%

“…41 33% of trials included in this review did not define what length the sham insoles were (8 of 24). 24,29,32,34,37,38,40,42 Most sham insoles that were described were the full length of the shoes (14 of 18, 78%), 21,23,25,28,30,31,33,35,39,43 and the rest were ¾ length, meaning the distal trimline finished proximal to the metatarsal heads.…”

Section: Risk Of Bias Assessmentmentioning

confidence: 99%

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Construction and validation of sham insoles used in clinical trials: A systematic review

Morrow

Theologis

Kothari

2022

Prosthetics &Amp; Orthotics International

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Background: Insoles are commonly prescribed to treat pathologies in a variety of patient groups; however, there is limited evidence to guide clinical decision-making. A well-validated sham insole is critical to conducting a double-blind placebo-controlled trial.Objectives: The aims were to establish: (1) How are sham insoles constructed? (2) What measures are undertaken to ensure adequate blinding? (3) What methods are used to validate the biomechanical effects? Study Design: A systematic search of the methodology of level I-II therapeutic evidence. Methods: Searches were conducted in MEDLINE, Embase, Cumulative Index of Nursing and Allied Health Literature, and Cochrane Central Register of Controlled Trials. Inclusion criteria were placebo-controlled clinical trials, sham insoles used, treatment insoles alter biomechanics, treatment insoles meet the ISO definition of foot orthotics, sham and treatment insoles tested in normal walking, and article available in English. Results: The search generated 270 results. Twenty-four trials were included. 19% of sham insoles were described sufficiently to be replicated. The most common sham construction characteristics were full length, ethylene-vinyl acetate material, and flat insoles. 58% of studies were double-blinded; however, many did not describe any blinding methods. There is evidence that blinding the intervention details and a similar insole appearance is effective to blind participants. 13% of studies included a shoe-only condition to allow assessment of the biomechanical effects of sham insoles. Conclusions: There is inconsistent construction, blinding, and biomechanical validation of sham insoles. This casts a substantial doubt on the quality and reliability of the evidence base to support the prescription of insoles.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Risk Of Bias Assessmentmentioning

confidence: 99%

Section: Risk Of Bias Assessmentmentioning

confidence: 99%

See 2 more Smart Citations

Construction and validation of sham insoles used in clinical trials: A systematic review

Morrow

Theologis

Kothari

2022

Prosthetics &Amp; Orthotics International

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“…In Japan, patients with CP often use AFO outside and insoles inside the shoes. Previous studies on patients with CP using insoles reported improvements of static standing and dynamic balance in timed up and go test and the gait parameters 3,4) . The dynamic balance consists of the ability to move the center of pressure (COP) within the base of support (BOS) and to move COP from a BOS to another BOS.…”

Section: Introductionmentioning

confidence: 89%

Characteristics of dynamic standing balance with and without an insole in patients with spastic diplegia cerebral palsy

et al. 2020

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This study examined characteristics of dynamic standing balance, with an without an insole, in patients with spastic diplegia cerebral palsy (CP). [Participants and Methods] This cross-sectional study used a crossover design. Eleven patients with spastic diplegia CP and gross motor levels between I and III with spastic diplegia CP (according to the Gross Motor Function Classification System expanded and revised version) were randomly allocated to either the barefoot or insole groups. The Index of postural stability (IPS) was evaluated while each patient was barefoot and while wearing insoles. The Pediatric Evaluation of Disability Inventory (PEDI) was used to measure functional self-care and mobility domains. [Results] While wearing the insoles, the center movement distance between right and left positions was significantly higher. While barefoot, IPS and area of postural sway correlated with the PEDI subscales for mobility and self-care. [Conclusion] Insoles promote standing balance and dynamic balance to move the center of pressure within the base of support. Such improvements may enhance activities of daily living in patients with spastic diplegia CP.

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Neurological Disorders in the Lower Extremity

Fernando¹,

Lazzarini²

2020

Neale's Disorders of the Foot and Ankle

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Postural insoles on gait in children with cerebral palsy: Randomized controlled double-blind clinical trial

Cited by 8 publications

References 27 publications

Construction and validation of sham insoles used in clinical trials: A systematic review

Construction and validation of sham insoles used in clinical trials: A systematic review

Characteristics of dynamic standing balance with and without an insole in patients with spastic diplegia cerebral palsy

Neurological Disorders in the Lower Extremity

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