Tokyo, Sept. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062759) titled 'A study of changes in gait before and after treatment and factors associated with gait in patients with joint, spinal, and neurological disorders' on Sept. 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 - Ehime University
Condition:
Condition - Osteoarthritis, osteonecrosis of the femoral head, chronic spinal disorders, Parkinson's disease, and parkinsonian syndromes
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to quantitatively evaluate gait before and after treatment in patients with joint, spinal, and neurological disorders using biomechanical analysis and to identify factors associated with gait and changes in gait after treatment by examining their relationships with patient characteristics, physical findings, imaging findings, and patient-reported outcomes.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Surgical treatment for joint and spinal disorders and pharmacological treatment for Parkinson's disease and parkinsonian syndromes are provided as part of routine clinical care. Treatment is determined by the attending physician according to each patient's clinical condition, and no treatment is assigned by the study protocol. Gait, physical findings, imaging findings, and patient-reported outcomes are assessed before treatment and within one year after treatment.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Patients undergoing surgical treatment for osteoarthritis, osteonecrosis of the femur, or chronic spinal disorders at our institution, or patients receiving treatment for Parkinson's disease or parkinsonian syndromes at our institution
2. Patients who can walk on level ground without assistance at the time of study enrollment
3. Patients who are able to answer questions regarding their subjective symptoms
4. Patients who are able to understand and respond to instructions and questions related to the study procedures
Key exclusion criteria - 1. Patients who are unable to complete patient-reported outcome assessments because of dementia or other conditions
2. Patients considered by the investigators to be unable to participate in or complete follow-up because of their health status
3. Patients considered by the investigators to have severe psychosocial disorders that could substantially affect study participation or study outcomes
4. Patients scheduled to participate in another clinical trial or clinical study within 30 days
5. Patients in a protected status, including those who are unable to provide valid consent because of impaired decision-making capacity
Target Size - 300
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 08 Month 24 Day
Date of IRB - 2026 Year 08 Month 24 Day
Anticipated trial start date - 2026 Year 08 Month 24 Day
Last follow-up date - 2030 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071853
Disclaimer: Curated by HT Syndication.