Tokyo, Jan. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000054490) titled 'Development and Clinical Application of a Therapist-Worn Gait Training Support System' on Jan. 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Kyoto Prefectural University of Medicine
Condition:
Condition - central nervous disease, bone and joint disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To develop a therapist-worn gait training support system and investigate its clinical efficacy.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Wearable sensors capable of measuring gait training parameters were attached to the patient, and the acquired data were transmitted in real time to a therapist-worn device to support gait training.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. Patients who are able to provide written informed consent to participate in the study of their own free will
2. Patients aged 20 years or older and younger than 90 years at the time of consent
3. Ability to participate in gait training
Key exclusion criteria - 1. Presence of a cardiac pacemaker
2. Pregnancy
3. Disturbance of consciousness or cognitive impairment
4. Recurrence
5. Requirement for gait assistance
6. Use of medications that affect heart rate
7. Inability or refusal to provide informed consent
8. Patients deemed inappropriate for participation by the attending physician or principal investigator etc
Target Size - 20
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2024 Year 09 Month 01 Day
Date of IRB - 2024 Year 10 Month 09 Day
Anticipated trial start date - 2025 Year 05 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=R000062236
Disclaimer: Curated by HT Syndication.