Tokyo, Feb. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060679) titled 'Changes in movement with a hip assist robotic orthosis' on Feb. 16.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - National Center for Geriatrics and Gerontology
Condition:
Condition - Cerebrovascular disease, bone and joint disease, spinal disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To explore changes in movement with robotic orthosis by gait analysis
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Subjects walk on the ground and on a treadmill in 5 conditions as follows: 1 without robotic orthosis, 2 robotic orthosis with power off, 3 robotic orthosis with low intensity, 4 robotic orthosis with high intensity, and 5 without robotic orthosis again. The 2-4 are performed in random order.
On the ground, subjects walk 8 meters twice at a comfortable walking speed. On the treadmill, subjects walk at a comfortable walking speed for 30 seconds.
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients who are able to walk on the ground and treadmill under supervision or independently, or with the use of suspension devices.
Key exclusion criteria - Patients with severe cognitive impairment, who require restrictions on exercise due to internal disease, and who have pain with robotic orthoses
Target Size - 50
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 01 Month 15 Day
Date of IRB - 2026 Year 01 Month 15 Day
Anticipated trial start date - 2026 Year 02 Month 16 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=R000069386
Disclaimer: Curated by HT Syndication.
