The Effect of Hyperbaric Oxygen Therapy for Acceleration Recovery After Anterior Cruciate Ligament Reconstruction(ACLR)
NCT Number: NCT06493851
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anterior Cruciate Ligament Reconstruction
Interventions: DEVICE: hyperbaric oxygen therapy
Sponsor: Assaf-Harofeh Medical Center
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2026-01-01
Locations: The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh), Zrifin, 70300, Israel

Summary:
The aim of the current study is to evaluate the effect of HBOT for acceleration recovery after ACLR.

Primary Outcome Measures: International Knee Documentation Committee, The aim of the international knee documentation committee (IKDC) is to detect improvement or deterioration in symptoms, function, and sport activity following knee impairment. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)., Change from Baseline immediately after the intervention
Secondary Outcome Measures: Knee MRI, At each of the evaluations, patients will undergo structural MRI scanning. Images will be acquired on MAGNETOM Vida 3T Scanner, configured with a channel receiver knee coils (Siemens Healthcare, Erlangen, Germany) at Shamir medical centre.

Edema and haemorrhage are seen as increased signal in the substance of the ACL in an acute injury., Change from Baseline immediately after the intervention|Laxity ligament test, Laxity ligament test includes 2 parts: 1- Lachman, anterior drawer, pivot - Manual assessment of the knee joint stabilization, The result will recorded as normal to severely abnormal according to criteria established by the IKDC. 2- KT-1000 - The KT-1000 test is knee arthrometer assessment for ACL laxity, The results of the KT-1000 examination will be recorded as normal to severely abnormal according to guidelines established by the IKDC ., Change from Baseline immediately after the intervention|physical measurement - ROM, ROM - Range of motion will be assessed with the patient in the supine position using a goniometer, passive knee flexion will be rated normal to severely abnormal according to established IKDC guidelines., Change from Baseline immediately after the intervention|physical measurement - Edema, Edema- One of the common measurement methods in research is knee perimetry, the assessor measures the knee girth at 3 points: the fold at the popliteal fossa (P0), 5 cm above P0 (PA), and 5 cm below P0 (PB). Data on perimetry were calculate., Change from Baseline immediately after the intervention|physical measurement - Vas for pain, Vas for pain - Pain scales are useful for the assessment of postoperative pain and based on self-reporting and represent subjective pain intensity, The evaluation is performed according to the IKDC., Change from Baseline immediately after the intervention|physical measurement - Maximal quadriceps power by dynamometer, Maximal quadriceps power by dynamometer - Quadriceps strength after ACLR usually assessed by isometric dynamometry and comparison the strength of the ACLR limb with the uninjured limb., Change from Baseline immediately after the intervention|Functional scores- (PROM), Tegner Lysholm knee scoring scale - patient-reported outcome measure (PROM) ,The total score is the sum of each response to the eight questions and may range from 0-100. Higher scores indicate a better outcome with fewer symptoms or disabilities, Score are categorized as excellent (95-100), good (84-94), fair (65-83), and poor (\<64)., Change from Baseline immediately after the intervention|Functional scores - Vas for global rating of knee function, Vas for global rating of knee function - measure the participation restrictions experienced during activities of daily living and sports by patients with a history of ACLR. rating of function by assessing the level of knee function on a 0 to 100 scale, with 0 points representing complete loss of function due to their knee injury and 100 points representing their level of function prior to their knee injury., Change from Baseline immediately after the intervention|Short form health survey (sf-36), Quality of life questionnaire, scale of 0-100, higher score means better outcome, Change from Baseline immediately after the intervention|Functional measurement, Balance Error Scoring System (BESS) - minimally clinical important difference (MCID) is 3 points and MDC intra-rater 7.3 points., Change from Baseline immediately after the intervention|Functional measurement - (SEBT), Modified Star Excursion Balance Test (SEBT) - Minimally clinical important difference (MCID) is 3.5% difference between the two legs., Change from Baseline immediately after the intervention|Functional measurement - Single Hop test, Single Hop test - MDC- score improved by 21.98 for women and 21.81 for man (as a % of leg length)., Change from Baseline immediately after the intervention