Here is the design of a clinical trial:

Official Title: Effect of Customized Software for Foot-related Exercises (SOPeD) for Prevention and Treatment of Foot Musculoskeletal Dysfunctions of People With Diabetic Neuropathy: FOotCAre (FOCAtrial-I) Randomized Controlled Trial

Included conditions:
- Diabetic Neuropathies

Study Armgroups:
- {'label': 'Intervention Group', 'type': 'EXPERIMENTAL', 'description': 'Patients in the intervention group will perform foot-related exercises described in the SOPeD software three times/week at home via web-software. In the follow-up period, patients will follow the same schedule set by the project till the end of the study.', 'interventionNames': ['Other: Physical therapy by foot-ankle segmental and functional exercises']}
- {'label': 'Control Group', 'type': 'NO_INTERVENTION', 'description': 'Participants in the control group will not receive any specific intervention in addition to the treatment recommended by the health professionals team (doctors, nurses, podiatrists), which includes pharmacological treatment, and self-care recommendations and foot care by international consensus.'}

Interventions:
- {'type': 'OTHER', 'name': 'Physical therapy by foot-ankle segmental and functional exercises', 'description': 'The physiotherapeutic foot-ankle exercise protocol is based on previous clinical trials. It was designed following three criteria established in a supervised, face-to-face intervention: muscle stretching; strengthening of the intrinsic muscles; and strengthening of the extrinsic foot-ankle muscles and functional exercises, such as balance and gait training. To avoid monotony, game principles were inserted to reward the exercise execution and enhance motivation. The exercises change from session to session, and the maximum duration is no longer than 20 minutes. The exercises should only be done 3 times/week; no more than eight exercises each day; and the individual difficulty is regulated by the effort scale to manage the customized progression. In total, 39 different exercises were chosen, and when including their sublevels of progression, a total of 104 different exercises can be completed.', 'armGroupLabels': ['Intervention Group']}

Primary Outcomes:
- {'measure': 'Change from Baseline Diabetic neuropathy symptoms at 12-weeks', 'description': 'Score of the Michigan Neuropathy Screening Instrument (MNSI). This questionnaire comprises 15 questions about symptoms and events related to leg and foot sensitivity and is administered by the participant himself. The answers are summed to get a total score. The sum of all items results in a score ranging from 0 to 13 (13 represents the worst rating of the diabetic neuropathy).', 'timeFrame': '12-weeks, 24-weeks (follow-up)'}
- {'measure': 'Change from Baseline of the Fuzzy classification of the diabetic neuropathy severity at 12-weeks', 'description': 'The fuzzy classification of the diabetic neuropathy severity will be given by the Fuzzy software score developed by the Laboratory of Biomechanics of Movement and Human Posture, available free of charge at: http://www.usp.br/labimph/fuzzy/. It is a decision support system for classification of the diabetic neuropathy. This decision is based on three domains: signs and symptoms extracted from the Michigan Neuropathy Screening Instrument; tactile sensitivity through the number of non-sensible areas using a 10-g monofilament; and vibration sensitivity by vibrating a tuning fork (128Hz) characterized as absent, present or diminished. The software produces a score from 0 to 10 and the higher the score, the more severe the diabetic neuropathy.', 'timeFrame': '12-weeks, 24-weeks (follow-up)'}

Please estimate the sample size based on the assumption: 
A statistical power of 0.80, an alpha of 0.05, and an effect size of 0.20 were used. The statistical design included F-test repeated measures and interaction between and within factors with two repeated measures and two study groups. A drop-out rate of 20% was estimated.
Sample size and statistical analyses
        The sample calculation was performed using the GPower v.3.1 program [60]. Two outcomes of extreme functional importance for patients with DPN were used to calculate the sample size. Considering the primary outcome (DPN symptoms), a medium effect size (0.52) was adopted and, for the secondary outcome (peak pressure at forefoot), a small effect size (0.20) was adopted. Both effect sizes were taken from the study by Sartor et al. [30] which evaluated the effect of a 12-week supervised physical therapy exercise in patients with DPN. In order to obtain the largest sample size, the smallest effect size (0.20) was used. A statistical design of F-test repeated measures and interaction between and within factors with two repeated measures and two study groups, a statistical power of 0.80, an alpha of 0.05, and an effect size of 0.20 were used for the sample size calculation. The resulting sample size was 52 individuals. A final sample size of 62 patients was then chosen after estimating a drop-out rate of 20%.
        The inferential statistical analysis will be based on an intention-to-treat analysis and per-protocol analysis. Mixed general linear models of analysis of variance for repeated measure will be used to detect treatmentâtime interactions (Î±â=â5%), and the NewmanâKeuls post hoc test will be used to obtain group effect (intervention group and control group), time effect (between T0 and T12), and groupâtime interaction. Effect sizes (Cohenâs d coefficient) will also be provided between T0 and T12 and between T12 and T24 to determine if the intervention shows any treatment effect. The difference between the means with their respective 95% confidence intervals will also be calculated. Imputation of any missing data for the analyzed variables will be conducted depending on the nature of the losses: missing completely at random, missing at random, or missing not at random. The per-protocol analysis will include only those patients who completed follow-up in the allocated intervention group. If there is evidence that the difference in the treatment depends on certain patient characteristics identified in the baseline assessment, a subgroup analysis will be performed.