Tokyo, May 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061658) titled 'A Study on the Quantitative Evaluation of Skin Softness in Healthy Adults and Patients with Lymphedema Using Tactile Sensors' on May 22.
Study Type:
Observational
Primary Sponsor:
Institute - Fujita Health University
Condition:
Condition - Healthy adults
Patients with lymphedema
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study examines the reliability and clinical utility of a tactile sensor developed by a collaborating research institution as a method for evaluating the effectiveness of skin care for patients with lymphedema.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Healthy Adults
1. Individuals who, prior to participating in this study, received a thorough explanation and provided written informed consent of their own free will based on a full understanding of the study
2. Individuals who are 18 years of age or older
3. Individuals whose general physical condition is stable and who are capable of independent postural and motor functions while in bed.
Inpatients or outpatients receiving lymphedema treatment at the Department of Rehabilitation, Fujita Health University Hospital
1. Participants who, prior to participating in this study, have provided written informed consent of their own free will or whose legal representative has provided written informed consent on their behalf after receiving a thorough explanation and demonstrating a full understanding of the study.
2. Participants who are 18 years of age or older.
3. Participants whose general medical condition is stable and who are capable of independent positioning and movement in bed.
Key exclusion criteria - Healthy adults
1. Those who have difficulty understanding instructions
2. Those who require assistance with bedside positioning and movements
3. Any other cases deemed inappropriate by the principal researcher or co-researchers
Inpatients or outpatients receiving lymphedema treatment at the Department of Rehabilitation, Fujita Health University Hospital
1. Those who have difficulty understanding instructions
2. Those who require assistance with bedside positioning and movements
3. Any other cases deemed inappropriate by the principal researcher or co-researchers
Target Size - 100
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 05 Month 21 Day
Date of IRB - 2026 Year 05 Month 21 Day
Anticipated trial start date - 2026 Year 05 Month 22 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070537
Disclaimer: Curated by HT Syndication.