Tokyo, Sept. 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062960) titled 'Effects of Different Wheelchair Seat Surfaces on Interface Pressure Distribution and Perceived Comfort' on Sept. 17.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Single blind -participants are blinded Control - Active

Primary Sponsor: Institute - Welloop Inc.

Condition: Condition - Wheelchair users and healthy individuals Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effects of different wheelchair seat surfaces. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Wheelchair seat made of elastic woven fabric Interventions/Control_2 - Conventional wheelchair seat made of nylon fabric

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - Inclusion Criteria for the Wheelchair User Group Individuals who use a wheelchair on a daily basis. Individuals classified as Level1 on the Hoffer Sitting Ability Classification. Individuals who understand the study information and can provide informed consent. Individuals who can understand the assessor's instructions and complete self-reported assessments. Individuals considered able to undergo the measurements safely at an adult day-care facility or similar setting.

Inclusion Criteria for the Healthy Adult Group Healthy adults who understand the study information and can provide informed consent. Key exclusion criteria - Exclusion Criteria for the Wheelchair User Group Individuals who have difficulty understanding the study information or measurement instructions because of severe cognitive impairment, aphasia, higher cortical dysfunction, or a similar condition. Individuals who are unable to maintain a quiet seated position during measurements or who have marked involuntary movements. Individuals with active pressure injuries, wounds, or severe skin lesions on the buttocks or posterior thighs. Individuals who are unable to continue the measurements because of severe pain or distress. Individuals who are unable to maintain the standardized sitting posture because of severe spinal deformity, pelvic deformity, joint contracture, or a similar condition. Individuals whose body weight exceeds the safe operating limit of the measurement equipment or study wheelchair. Individuals considered unsuitable for participation by the principal investigator or the therapist responsible for the assessment.

Exclusion Criteria for the Healthy Adult Group Individuals with a medical history or condition that makes it difficult to maintain a seated position, those with pain or skin lesions on the buttocks or thighs, or those considered unable to undergo the measurements safely. Target Size - 50

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 09 Month 01 Day Date of IRB - 2026 Year 09 Month 07 Day Anticipated trial start date - 2026 Year 09 Month 07 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072090

Disclaimer: Curated by HT Syndication.