Tokyo, July 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062118) titled 'A foundational study evaluating dynamic stability of prosthetic gait using wearable sensors' on July 3.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Hokkaido University of Science

Condition: Condition - Healthy adult gait (no target disease). A non-therapeutic foundational study to validate methods for evaluating dynamic stability of prosthetic and orthotic gait. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - In healthy adults, mock prosthesis attachment and metronome-cued walking are performed, and gait data recorded with a pelvic wearable sensor smartphone are used to calculate the maximum finite-time Lyapunov exponent lambda max. The objectives are 1 to determine the minimum number of steps required for lambda max to reach a plateau 2 to validate whether lambda max from concatenated short walking segments can serve as a surrogate for lambda max from continuous walking using ICC and Bland-Altman analysis and 3 to examine the effects of free versus metronome-regulated walking and presence versus absence of mock prosthesis attachment on lambda max. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Duration one visit per participant total about 90-120 minutes. Four within-subject conditions in sequence. 1 Free walking normal without mock prosthesis self-paced continuous about 300-400 steps and short segments. 2 Free walking with mock prosthesis on right lower limb self-paced continuous and short segments. 3 Regulated walking with mock prosthesis synchronized to individual metronome at conversational volume. 4 Regulated walking without mock prosthesis synchronized to same metronome. Order of conditions 3 and 4 is randomized per participant.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1. Healthy adults aged 18 years or older 2. Students graduate students or faculty and staff of Hokkaido University of Science 3. Able to understand the study in Japanese and provide voluntary consent 4. Able to walk safely on indoor level walkway and wear mock prosthesis safely Key exclusion criteria - 1. Neuromusculoskeletal disease balance disorder or severe visual or hearing impairment affecting gait 2. Pregnancy or self-reported possibility of pregnancy 3. Unable to wear mock prosthesis safely or with significant pain 4. Assessed by investigators as high fall risk Target Size - 12

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 01 Day Anticipated trial start date - 2026 Year 08 Month 01 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=R000071085

Disclaimer: Curated by HT Syndication.