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

NCT05929118 | Completed

• 1 other identifier: 2022158H
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydrotherapy; Gait; Muscle Function; Anterior Cruciate Ligament Reconstruction

Outcome Measures

Primary Outcomes (12)

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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.

• Stiffness Change

  Stiffness indicates the resistance of a muscle to contraction or to an external force that deforms its initial shape. 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).

• Decrement Value Change

  The Decrement (Dec) value represents a muscle's ability to return to its initial shape after the reduction or removal of an external force, with muscle elasticity being inversely proportional to the Dec value. A lower Dec value indicates greater muscle elasticity. 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 Outcomes (2)

• Degree of Knee Swelling Change

  Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).

• Thigh Muscle Atrophy Change

  Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).

Study Arms (2)

Aquatic Rehabilitation

EXPERIMENTAL

Each group performed 70-90 minutes per session for a total of 6 interventions, all of which included warm-up activities, mobility training, strength training, functional exercise, and finishing activities. Each training was conducted 1-2 days apart, 2-3 times per week, and the training was completed within 2-3 weeks.

Other: Aquatic Rehabilitation

Land-based Rehabilitation

EXPERIMENTAL

Each group performed 70-90 minutes per session for a total of 6 interventions, all of which included warm-up activities, mobility training, strength training, functional exercise, and finishing activities. Each training was conducted 1-2 days apart, 2-3 times per week, and the training was completed within 2-3 weeks.

Other: Land-based Rehabilitation

Interventions

Land-based Rehabilitation OTHER

Peking University Third Hospital Anterior Cruciate Ligament (ACL) Postoperative Rehabilitation Guidelines.

Land-based Rehabilitation

Aquatic Rehabilitation OTHER

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.

Aquatic Rehabilitation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Sport University: lead

Study Sites (1)

Beijing Sport University

Beijing, Beijing Municipality, 100084, China

Location

Study Officials

• Lin Song, Doctor

  Beijing Sport University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: July 3, 2023
• Study Start: November 1, 2020
• Primary Completion: December 15, 2022
• Study Completion: February 3, 2023
• Last Updated: January 5, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)