Clinical Research Directory

Sensory Stimulation as a Driver of Diet-induced Thermogenesis

This study aims to assess the influence of sensory stimulation on diet-induced energy expenditure by way of a clinical cross-over trial in 24 healthy participants either receiving a meal bolus with (orally) and without sensory stimulation (nasogastric-tube).

Longitudinal Evaluation of Direct Neurotization Technique in Breast Reconstruction With Fully Autologous Components

This clinical trial aims to evaluate whether direct neurotization using fully autologous components during autologous breast reconstruction improves postoperative breast sensation and sensory-related quality of life in women undergoing unilateral mastectomy. Direct neurotization involves coapting the recipient intercostal nerve to an autologous nerve graft placed within the flap to facilitate reinnervation. The study's primary questions are: 1. Does direct neurotization using fully autologous nerve grafts improve cutaneous sensory recovery, as assessed by Semmes-Weinstein monofilament thresholds measured at standardized breast locations? 2. Does neurotization enhance patient-reported sensory outcomes and quality of life, as assessed by the BREAST-Q Sensation Module? As secondary objectives, the study will assess whether biological predictors of nerve regeneration correlate with sensory outcomes. These include: 1. Neuregulin-1 (NRG1) expression in flap tissue biopsy; 2. Cross-sectional area of the recipient nerve fibres; 3. Breast morphometry measured at baseline and follow-up; 4. Intraepidermal nerve fibre density (IENFD) on skin biopsy. Participants will be randomly assigned to receive either: 1. Neurotized autologous breast reconstruction using fully autologous graft components, or 2. Standard (non-neurotized) autologous breast reconstruction. The study will compare these groups to determine whether neurotization accelerates or enhances the return of breast sensation over a 6-month follow-up period, with evaluations at 1 month, 3 months, and 6 months after surgery. Participants will undergo: 1. Autologous breast reconstruction with or without direct neurotization as part of their planned cancer surgery. 2. Sensory testing using Semmes-Weinstein monofilaments at baseline, 1, 3, and 6 months. 3. Completion of BREAST-Q questionnaires evaluating breast sensation, symptoms, and quality of life at each follow-up visit. 3\. Intraoperative tissue sampling for NRG1 analysis and nerve morphometry. 4. Skin biopsy (if applicable) to assess intraepidermal nerve fibre density. 5. Breast morphometry assessment using a breast morphometry measurement software tool. This study seeks to provide high-quality evidence on the effectiveness of direct neurotization using fully autologous components in restoring breast sensation and to explore biological predictors that may influence sensory recovery after autologous breast reconstruction.

Additional Effects of Proprioceptive Neuromuscular Facilitation With Otago Exercises on Fall Risk in Diabetes Mellitus Patients

Diabetes Mellitus is considered as one of the most prevalent issues among global population and 50% of all the diabetic patients particularly diabetes type II develop peripheral neuropathy. Diabetic Peripheral Neuropathy (DPN) affects feet and legs first, followed by the hands and arms. This study will involve two groups, one performing the Otago Exercise Program, and the other performing a combined PNF and Otago exercise protocol. This study aims to assess the additional effects of Proprioceptive Neuromuscular Facilitation with Otago Exercise Program on Risk of fall which will be assessed by assessing balance, Fear of Fall and Sensory Function. Key outcome measures, including the Berg Balance Scale, Fall Efficacy Scale, Functional Reach test and Semmes Weinstein Monofilament Test will be used in evaluating the effectiveness of the exercise interventions. The participants would be screened through Michigan Neuropathy Screening Instrument and Berg Balance scale for inclusion criteria, and outcome measures will be assessed by using Berg Balance Scale, Fall efficacy scale, Functional Reach Test and Semmes Weinstein Monofilament testing method on the day of starting the intervention and on the last day of intervention. Intervention will be given for a total of 40-50 minutes per session, 3 sessions/week for consecutive 6 weeks And than the data will be recorded at the end of 6 weeks again.

Effects of Thumb Manipulation on Hand Grip Strength, Function, and Sensation

This randomized controlled study will aim to investigate the effects of thumb manipulation on hand grip strength, function, and sensation in healthy individuals. A total of 60 volunteers aged between 18 and 50 years will be recruited from Ortadağ Special Education and Rehabilitation Center. Participants will be randomly assigned to either a chiropractic manipulation group (n=30) or a control group (n=30), with an equal distribution of males and females in each group. The intervention group will receive thumb manipulation twice weekly for 4 weeks, while the control group will not receive any intervention. Outcome measures will include two-point discrimination (assessed with a discriminator), hand grip strength (measured using a dynamometer), pinch strength (evaluated with a pinch meter), and hand function (measured by the Duruöz Hand Index). Statistical analyses will be performed with a significance level set at p\<0.05. It is expected that participants in the manipulation group will show greater improvements in all measured parameters compared to the control group, suggesting a positive effect of thumb manipulation on hand-related sensorimotor functions in healthy individuals.