The Effect of Aquatic Rehabilitation on Knee Function in Anterior Cruciate Ligament Reconstruction Patients.

Anterior Cruciate Ligament Reconstruction Clinical Trial

Official title:

The Impact of Aquatic Rehabilitation on Gait and Muscle Function in Patients After Anterior Cruciate Ligament Reconstruction.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05929118
• Other study ID #: 2022158H
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: February 3, 2023

Study information

• Verified date: May 2023
• Source: Beijing Sport University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 3, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction
• Gait
• Hydrotherapy
• Muscle Function

Intervention

Other:
• Aquatic Rehabilitation
Reviewing the existing literature studies and related books, and combining the post-operative rehabilitation process of ACLR with the opinions of experts from the China Aquatic Rehabilitation Association, the Aquatic rehabilitation program of this study was designed.
• Land-based Rehabilitation
Peking University Third Hospital Anterior Cruciate Ligament (ACL) Postoperative Rehabilitation Guidelines.

Locations

Country	Name	City	State
China	Beijing Sport University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Sport University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stride Length Change	Kinovea 0.8.15 software was used for gait video calibration to analyze and calculate the stride length, which is the longitudinal linear distance between two consecutive heel touches on the same side of the foot during walking. The time, place, and testers of the test were kept consistent.	Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Primary	Step Length Change	Kinovea 0.8.15 software was used to calibrate the gait video to analyze and calculate the step length, which is the longitudinal linear distance between two points when the left and right heels touch the ground during walking. The time, place, and testers of the test were kept consistent.	Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Primary	Stride Length Time Change	Kinovea 0.8.15 software was used to calibrate the gait video to analyze and calculate the stride length, which is the time between two consecutive landings on the same side of the heel during walking. The time, place, and testers of the test were kept consistent.	Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Primary	Step Length Time Change	Kinovea 0.8.15 software was used to calibrate the gait video to analyze and calculate the step length time, which is the time between the two points where the left and right heels touch the ground during walking. The time, place, and testers of the test were kept consistent.	Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Primary	Single Support Phase Change	Kinovea 0.8.15 software was used to calibrate the gait video to analyze and calculate the single support phase, which is the time between the toe of one foot leaving the ground and the foot following the ground on that side during walking. The time, place, and testers of the test were kept consistent.	Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Primary	Oscillation Frequency Change	Oscillation Frequency (Hz) is the intrinsic pressure of the muscle, that is, the pressure carried by the muscle itself in the relaxed state or in the absence of voluntary contraction, and represents the muscle tone. The time, place, and testers of the test were kept consistent.	Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Primary	Mechanical Stress Relaxation Time Change	Mechanical Stress Relaxation Time (MSRT) is the time required for the muscle to return from its deformed state to its original state after active contraction or withdrawal of external pressure. The time, place, and testers of the test were kept consistent.	Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Primary	Creep Change	Creep (Deborah number) is the ratio of the mechanical stress release time to the time required for the muscle to reach maximum deformation by external force, SRT and Creep represent muscle viscosity. The time, place, and testers of the test were kept consistent.	Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Primary	Range of Motion Change	Active and passive Range of Motion in knee flexion. The time, place, and testers of the test were kept consistent.	Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Primary	2000 IKDC Subjective Knee Evaluation Form Change	2000 IKDC Subjective Knee Evaluation Form is divided into three modules: knee symptoms (7 questions), motor activity (10 questions) and self-functional score (2 questions), where knee symptoms include frequency and degree of pain, stiffness, swelling, locking and instability; motor activity includes activity level, going up and down stairs, squatting, kneeling straight down, sitting and standing up with bent knees, running, jumping and landing on the affected limb, and quick starts and stops; and self-functional score includes pre-injury and current self-functional scores, graded from unable to perform daily activities (0 points) to unrestricted daily activities (10 points). The time, place, and testers of the test were kept consistent.	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.
Secondary	Degree of Knee Swelling Change	The circumference of the knee joint was measured with a soft tape to indicate the degree of swelling of the knee joint. The subject was placed in a supine position with the lower extremities in a slightly flexed and relaxed position, and the hands were placed naturally on the side of the body. The medial and lateral femoral condyles were used as the midline of the knee joint, and the circumference of the knee joint enclosed by this midline was measured and recorded with the upper edge of the soft dipstick to reflect the swelling of the knee joint. The swelling effect of the intervention was reflected by the change in the circumference of the knee before and after training, and the difference in circumference between the two sides could reflect the degree of swelling. The time, place, and testers of the test were kept consistent.	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	Thigh Muscle Atrophy Change	Thigh circumference can indirectly indicate the strength of the knee flexor and extensor muscles by indirectly reflecting the cross-sectional area of the thigh muscles, so the circumference of the thigh at 10 cm above the patella was measured with a soft dermatome to reflect the muscle strength of the thigh, and the resulting atrophy index was calculated to reflect the degree of atrophy of the thigh. The time, place, and testers of the test were kept consistent.	Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).