Clinical trial NCT05929118: The Effect of Aquatic Rehabilitation on Knee Function in Anterior Cruciate Ligament Reconstruction Patients.
Official title: The Impact of Aquatic Rehabilitation on Gait and Muscle Function in Patients After Anterior Cruciate Ligament Reconstruction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction
Hydrotherapy
Gait
Muscle Function
Lead sponsor: Beijing Sport University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the applicability and effectiveness of an aquatic rehabilitation training program with a conventional land-based rehabilitation program in terms of lower extremity biomechanics and knee function in Anterior Cruciate Ligament Reconstruction (ACLR) patients. The main questions it aims to answer are:

* Does aquatic rehabilitation accelerate the recovery of gait symmetry and muscle function in patients after ACLR？
* Previous studies have not uncovered the training characteristics of aquatic rehabilitation, which allow for training movements that cannot be performed on land, and it is unknown whether these different training movement characteristics are more effective for patients with ACLR.

Participants were randomly divided into an aquatic rehabilitation group (AR) and a land-based rehabilitation group (LR), and each group performed 70-90 minutes of training per session for a total of 6 sessions. This included warm-up activities, mobility training, strength training, functional exercises, and finishing activities. Each training session was conducted 1-2 days apart, 2-3 sessions per week, and the training was completed within 2-3 weeks.

Detailed description: Twenty subjects were finally included through the screening criteria. The names of all subjects were entered into Microsoft Excel 2016 and the RAND function was used to generate a random number between 0 and 1 for each subject, each random number being different. Subjects with an odd number of random numbers were assigned to the aquatic rehabilitation group and those with an even number of random numbers were assigned to the terrestrial rehabilitation group. The final two intervention groups of 10 participants, including 7 males and 3 females, were assigned and baseline testing was performed. Different phases of the training program were developed and adjusted according to the subjects' postoperative time. Testing was repeated after completion of the intervention, and International Knee Documentation Committee (IKDC) 2000 follow-up was performed at one year.

The technical route of this study was to collect basic information about the study subjects, including age, height, weight, injury history, surgery, and current recovery, and to test the muscle function, degree of knee swelling, thigh circumference, knee flexion mobility, closed-eye balance ability and gait of the study subjects, who filled in the IKDC2000 score. Each intervention group was then trained separately for 70-90 minutes each time for a total of 6 sessions, and post-intervention testing was performed with the same testing procedure as the pre-intervention testing. The IKDC score was used again for follow-up one year after the end of the intervention, and the relevant indexes were collected for collation and then compared and analyzed to discuss the effect of each intervention method on patients in the early postoperative period after ACLR.

Basic information and experimental data entry and organization were performed using Microsoft Excel 2016, and the results of all indicators measured before and after the experiment were analyzed and calculated in International Business Machines (IBM) SPSS Statistics 26.0. The data were tested for normality using the Shapiro-Wilk Test (Shapiro-Wilk Test). For the series conforming to the normal distribution, expressed as mean (Mean) and standard deviation (SD), the independent samples t-test was used to compare whether there was a statistically significant difference in baseline values between the 2 intervention groups, the paired samples t-test was used to observe whether there was a statistically significant difference between each intervention method before and after the intervention, and the independent samples t-test was used to compare the post-intervention Whether there was a statistically significant difference in efficacy between the 2 intervention groups; the series that did not conform to the normal distribution were expressed as median and quartile (Q), and the Mann-Whitney U test was used to compare the baseline values of different training groups, and the Wilcoxon signed rank test in the non-parametric method was used to observe whether there was a statistically The Mann-Whitney U test was used to compare the efficacy of the different training groups after the intervention. Significant differences were set at P \< 0.05 and very significant differences at P \< 0.01.

Eligibility criteria: Inclusion Criteria:

* Patients 4-8 weeks after unilateral ACL reconstruction surgery, or combined meniscus removal or resection, or 6-10 weeks after combined meniscus suturing after unilateral ACL reconstruction;
* No other lower extremity injury in the last 3 months, except for meniscal injury.

Exclusion Criteria:

* Contraindications related to underwater conditions such as open wounds, infectious diseases, history of neurological diseases (stroke, degenerative diseases of the central or peripheral nervous system, etc.), and being on psychotropic or anti-hypertensive drugs;
* Fear of water and inability to comply with experimental arrangements;
* History of ACL reconstruction surgery on the contralateral lower extremity and not more than half a year ago.

Primary outcomes:
measure: Stride Length Change
timeFrame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
measure: Step Length Change
timeFrame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
measure: Stride Length Time Change
timeFrame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
measure: Step Length Time Change
timeFrame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
measure: Single Support Phase Change
timeFrame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
measure: Oscillation Frequency Change
timeFrame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
measure: Mechanical Stress Relaxation Time Change
timeFrame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
measure: Creep Change
timeFrame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
measure: Range of Motion Change
timeFrame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
measure: 2000 IKDC Subjective Knee Evaluation Form Change
timeFrame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention). Follow-up was performed again one year after the end of the intervention using the IKDC score.
measure: Stiffness Change
timeFrame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
measure: Decrement Value Change
timeFrame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Secondary outcomes:
measure: Degree of Knee Swelling Change
timeFrame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
measure: Thigh Muscle Atrophy Change
timeFrame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Sport University
state: Beijing
Study officials:
affiliation: Beijing Sport University
name: Lin Song, Doctor
role: STUDY_CHAIR
affiliation: Beijing Sport University
name: Zekun Liu, Bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Sport University
name: Shuyuan Yan, Master
role: PRINCIPAL_INVESTIGATOR
References: