Tokyo, Aug. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058775) titled 'A study to track the relationship between knee bending motion and fear of movement in patients after total knee replacement surgery, and to investigate the rehabilitative effects on fear of movement' on Aug. 13.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Historical
Primary Sponsor:
Institute - Other
Condition:
Condition - Osteoarthritis of the knee (after total knee arthroplasty)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to clarify the relationship between kinematic data and movement fear in weight-bearing knee flexion movements in patients who have undergone total knee arthroplasty (TKA), with the goal of obtaining scientific knowledge that will contribute to the establishment of clinical intervention guidelines. Furthermore, rehabilitation interventions will be implemented for patients with movement fear, and the effects of these interventions on movement fear and kinematic indicators will also be verified.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Pain neuroscience education plus graded exposure in addition to usual postoperative rehabilitation.
Eligibility:
Age-lower limit - 40
years-old
Gender - Male and Female
Key inclusion criteria - Patients who have undergone total knee arthroplasty (TKA) with the same implant model performed by the same surgeon at Toshiyama-kai Kiba Hospital.
Key exclusion criteria - 1. Patients with difficulty understanding tasks due to severe cognitive decline, 2. Patients with a history of central nervous system disease, 3. Patients with a history of surgery on other parts of the body within the past 3 months, 4. Patients with other lower limb diseases (hip osteoarthritis, rheumatism, etc.), 5. Patients with chronic pain from before surgery.
Target Size - 130
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 05 Month 10 Day
Date of IRB - 2023 Year 05 Month 15 Day
Anticipated trial start date - 2025 Year 05 Month 15 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=R000067183
Disclaimer: Curated by HT Syndication.