Tokyo, Dec. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059991) titled 'How electrical muscle stimulation affects quadriceps muscle thickness in patients after anterior cruciate ligament reconstruction using quadriceps tendon?' on Dec. 5.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Kanazawa University
Condition:
Condition - Anterior cruciate ligament injury
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - In patients who undergo anterior cruciate ligament reconstruction using quadriceps tendon, postoperative recovery of knee extensor strength is often insufficient, potentially delaying safe and early return to sports. The aim of this study is to examine, in a prospective randomized controlled trial, whether electrical muscle stimulation of the quadriceps modifies quadriceps muscle thickness after ACL reconstruction using quadriceps tendon.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Standard postoperative physical therapy program after anterior cruciate ligament reconstruction plus electrical muscle stimulation applied to the quadriceps muscle.
Interventions/Control_2 - Standard postoperative physical therapy program after anterior cruciate ligament reconstruction.
Eligibility:
Age-lower limit - 12
years-old
=
Gender - Male and Female
Key inclusion criteria - - Patients undergoing primary anterior cruciate ligament reconstruction
- Patients in whom a quadriceps tendon autograft is used for ACL reconstruction
- Patients who participated in sports activities before injury (Tegner Activity Level Scale > 6)
Key exclusion criteria - - Patients with multi-ligament knee injuries
- Patients who do not aim to return to sports
- Patients with a history of lower limb surgery or neuromuscular diseases
Target Size - 52
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2024 Year 06 Month 10 Day
Date of IRB - 2024 Year 12 Month 19 Day
Anticipated trial start date - 2025 Year 12 Month 05 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068585
Disclaimer: Curated by HT Syndication.