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The Effect of Personalized Shoe Insoles on Parkinson's Disease Subjects: A Triple-Blind Randomized Controlled Trial.

ABSTRACT: Subjects with Parkinson's Disease (PD) display different motor and non-motor symptoms. Different therapies have been shown to be effective, such as plantar foot stimulation, which has proved to be effective for motor symptoms. Different stimulation methods were proposed and tested through specific devices, or insoles. Our aim was to assess the effect of a newly designed custom-made insole called PRO-STEP compared with a flat sham insole on subjects with PD. Subjects were randomized 1:1 into two arms and were asked to wear PRO-STEP or sham insoles for at least 6 h per day for 10 weeks. Participants were evaluated at four timepoints. Forty-two subjects were randomly assigned to the PRO-STEP (EG) or sham group (SG). The comparison of the EG and SG without and with insoles (T0-T1) did not show significant differences in the TUG time and in the 10MWT gait parameters. At T1, T2, and T3 TUG time, BBS, SF12-MC, and SF12-PC did not show significant differences. The satisfaction level with the PRO-STEP or sham insoles was high in both groups. PD patients were satisfied with PRO-STEP insoles; however, plantar foot stimulation is not effective from a functional perspective. Future studies should consider possible modifications to the proposed stimulation to improve its effectiveness in patients with PD.

SUBMITTER: Pollet J

PROVIDER: S-EPMC10707212 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature

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The Effect of Personalized Shoe Insoles on Parkinson's Disease Subjects: A Triple-Blind Randomized Controlled Trial.

Pollet Joel J Buraschi Riccardo R Ranica Giorgia G Pancera Simone S Anastasi Denise D Fazio Rossella R Monteleone Serena S Lena Eleonora E Floridi Valeria V Zucchini Franco F Falso Maurizio Vincenzo MV

Journal of clinical medicine 20231121 23

Subjects with Parkinson's Disease (PD) display different motor and non-motor symptoms. Different therapies have been shown to be effective, such as plantar foot stimulation, which has proved to be effective for motor symptoms. Different stimulation methods were proposed and tested through specific devices, or insoles. Our aim was to assess the effect of a newly designed custom-made insole called PRO-STEP compared with a flat sham insole on subjects with PD. Subjects were randomized 1:1 into two ...[more]

PMID: 38068255

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Project description:IntroductionPeripheral neuropathy is a major risk factor for falls in adults with diabetes. Innovative footwear devices which artificially manipulate the sensory environment at the feet, such as textured shoe insoles, are emerging as an attractive option to mitigate balance and walking problems in neuropathic populations. This study aims to explore whether wearing textured insoles for 4 weeks alters balance performance in adults with diabetic peripheral neuropathy.Methods and analysisA prospective, single-blinded randomised controlled trial with parallel groups will be conducted on 70 adults with diabetic peripheral neuropathy. Adults with a diagnosis of peripheral neuropathy (secondary to type 2 diabetes), aged ≥18 years, ambulant over 20 m (with/without an assistive device), will be recruited. Participants will be randomised to receive a textured insole (n=35) or smooth insole (n=35), to be worn for 4 weeks. During baseline and post intervention assessments, standing balance (foam/firm surface; eyes open/closed) and walking tasks will be completed barefoot, wearing standard shoes only, and two different insoles (smooth, textured). The primary outcome measure will be centre of pressure (CoP) velocity, with higher values indicating poorer balance. Secondary outcome measures include walking quality (gait velocity, base of support, stride length and double-limb support time), physical activity levels, foot sensation (light-touch pressure, vibration) and proprioception (ankle joint position sense), and other balance parameters (CoP path length, anteroposterior and mediolateral excursion). Patient-reported outcomes will be completed evaluating foot health, frequency of falls and fear of falling. Data will be analysed using a repeated measures mixed models approach (including covariates) to establish any differences between-groups, for all outcome measures, over the intervention period.Ethics and disseminationEthical approval has been obtained from the institutional Human Research Ethics Committee (#2017000098). Findings will be disseminated at national and international conferences, through peer-reviewed journals, workshops and social media.Trial registration numberACTRN12617000543381; Pre-results.

Project description:BackgroundConsidering the importance of sexual function, high prevalence of sexual dysfunction (especially dyspareunia caused by atrophic vaginitis) in breastfeeding women, and lack of effective interventions, the present research aimed to determine the effect of oxytocin (OXT) vaginal gel on sexual function (primary outcome), sexual satisfaction, and depression (secondary outcomes) in the breastfeeding women.MethodsThis randomized triple-blind controlled trial was conducted on 64 breastfeeding women who referred to health centers in the city of Tabriz, Iran, in 2020-21. Participants were equally assigned to intervention/control groups using block randomization. 200 IU of OXT vaginal gel was given to the participants in the intervention group daily for eight week and the same protocol was carried out for the control group with placebo. Standard questionnaires of Female Sexual Function Index (FSFI), Edinburgh Postpartum Depression Scale (EPDS) and Sexual satisfaction scale for women (SSSW) were completed at baseline and 8 weeks after intervention. ANCOVA test was used to compare post-intervention mean score of the groups, adjusted for the baseline values.ResultsAfter intervention, there was no statistically significant difference between groups in terms of mean total score of FSFI (Adjusted Mean Difference (AMD): 1.14; 95% Confidence Interval (95% CI): -1.28 to 9.16; P= 0.349) and sexual satisfaction (AMD: 5.01; 95% CI: -0.53 to 10.56; P= 0.075). However, there was statistically significant difference between the groups in terms of mean scores of sexual contentment (AMD: 1.56; 95% CI: 0.29 to 2.83; P = 0.017) and depression (AMD: -1.90; 95% CI: -1.27 to -2.54; P < 0.001). One participant in the OXT group and one participant in the placebo group reported mild uterine contraction and one person in the placebo group reported vaginal burning sensations.ConclusionsNo evidence was found for the effects of OXT gel in the improvement of FSFI, even though, OXT significantly improved sexual satisfaction in the domain of contentment, and improved the symptoms of depression in comparison to the placebo group. However, a definite conclusion requires more research in this regard.Trial registrationthe Iranian Registry of Clinical Trials (IRCT), code: IRCT20120718010324N55 , Date of registration: 27/05/2020, URL: https://en.irct.ir/user/trial/44986/view .

Dataset Information

The Effect of Personalized Shoe Insoles on Parkinson's Disease Subjects: A Triple-Blind Randomized Controlled Trial.

Publications

The Effect of Personalized Shoe Insoles on Parkinson's Disease Subjects: A Triple-Blind Randomized Controlled Trial.

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