An interventional study of Modellata in Body Fat Distribution and Cellulitis, sponsored by Indústria Brasileira Equipamentos Médicos - IBRAMED. Status unknown at 1 site in Brazil. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-18.
Sponsored by Indústria Brasileira Equipamentos Médicos - IBRAMED · Not applicable, Interventional, and Treatment
OBJECTIVE: To evaluate the efficacy of vibro-oscillatory therapy through an electromedical equipment in improving body contour and appearance of cellulite.
SUBJECTS AND METHODS: A prospective and comparative longitudinal clinical study will be performed in 30 women with cellulitis. Patients will be submitted to data collection and evaluation and before and after vibration-oscillatory therapy.
HYPOTHESES: Patients are expected to show improvement in body contour and cellulite after vibration-oscillatory therapy.
STATISTICAL ANALYSIS: A descriptive analysis will be done before and after vibration-oscillatory therapy, with frequency tables for categorical and descriptive variables (mean, standard deviation, median, minimum and maximum values) for continuous or numerical variables. In order to compare the main variables between the groups and the collection times, the analysis of variance (ANOVA) for repeated measures will be used. Tukey's test will be used to compare the groups. The significance level adopted for the statistical tests will be 5% or p \<0.05.
After approval by the institutional committee of Research Ethics, the subjects will be approached by the researcher responsible on the day of their evaluation, where they completed the registration form, after a brief analysis of the inclusion and exclusion criteria of the present study, the individuals included in the study will be collection of anthropometric data: weight, height, BMI, perimeter of the treated region, assessment of the degree of gynoid lipodystrophy, clinical inspection and photographic study of the treated area, ultrasound examination to assess the thickness of the dermis and hypodermis and the examination with Cutometer ® to assess the viscoelasticity of the skin.
Patients will be divided according to the degree of cellulite they present and will be treated with vibration therapy, such as the Modellata® electromedical equipment (Ibramed- Brazilian Industry of Electronic Equipment), being performed three times a week for two months totaling 16 sessions by a dermato-functional physiotherapist.
Data collection and evaluation will be performed before and after treatment.
160 studies on the registry are indexed under Cellulitis; 14 are open to participants now.
This study's planned enrollment of 30 is below the median of 157 across 124 interventional studies indexed under Cellulitis.
Browse Cellulitis studies →Indústria Brasileira Equipamentos Médicos - IBRAMED is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
treatment such as the Modellata electromedical device (Ibramed), in the abdomen, flanks, thigh posterior, inner thigh and buttocks. Being performed twice a week, with a total duration of 50 minutes to the session, being 10 sessions total to end the treatment.
Device: Modellata
treatment such as the Modellata electromedical device (Ibramed), in the abdomen, flanks, thigh posterior, inner thigh and buttocks.
Improve body contour
Perimetry, photos, and ultrasound
Time frame: 1 hour per session (10 sessions 5 weeks).
Improve appearance of cellulite
perimetry, photos, ultra son, degree of cellulite
Time frame: 1 hour per session (10 sessions 5 weeks).
Plan to share: Undecided
No publications or documents are linked to this record.
Started Oct 2017 (actual). Primary completion is estimated for Dec 2017, 1 month after the start.
Of 18 interventional studies with no phase under Cellulitis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 27. This study's planned 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Indústria Brasileira Equipamentos Médicos - IBRAMED