Effectiveness of Rehabilitation After Arthroscopic ACL Reconstruction Using Inertial Exercises

NCT ID: NCT06726044

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-02

Study Completion Date

2023-02-28

Brief Summary

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The primary aim of the study was to compare the effectiveness of two rehabilitation protocols for patients following ACL reconstruction. The first group (SR) underwent standard rehabilitation, which included the following treatments:

Manual therapy: manual mobilization of the patella and fibular head Anti-swelling therapy: manual lymphatic drainage techniques Compression and cryotherapy Reflex therapy: clavi-therapy Kinesiotherapy: strength exercises Kinesiotaping Osteopathic techniques Myofascial release Manual scar treatment Activation of gliding movement in the knee joint; soft tissue techniques in the popliteal region Flossing Knee flexion and extension exercises in a closed and next in open kinematic chain Isometric quadriceps exercises at full extension and 45-degree flexion

In addition to the above, the second group (SR+I) performed inertial exercises, which were introduced starting from the fifth week of rehabilitation. After 12 weeks of rehabilitation, its effectiveness was evaluated using standard tests.

The results indicate that the innovative rehabilitation protocol incorporating inertial exercises can be effectively applied in the rehabilitation of individuals following arthroscopic ACL reconstruction. None of the monitored rehabilitation effectiveness indicators in the SR+I group were inferior to those in the SR group. Moreover, certain parameters assessing rehabilitation effectiveness showed the SR+I protocol to have advantages over the SR protocol.

Detailed Description

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The primary goal of the study was to compare the effectiveness of two rehabilitation protocols in patients following ACL reconstruction. The first group (SR), consisting of 12 participants, underwent a standard rehabilitation program twice a week for 12 weeks. Each session lasted approximately 60 minutes and was conducted by the same therapist. The standard rehabilitation program included the following treatments:

Manual therapy: manual mobilization of the patella and fibular head Anti-swelling therapy: manual lymphatic drainage techniques Compression and cryotherapy Reflex therapy: clavi-therapy Kinesiotherapy: strength exercises Kinesiotaping Osteopathic techniques Myofascial release Manual scar treatment Activation of gliding movement in the knee joint; soft tissue techniques in the popliteal region Flossing Knee flexion and extension exercises in closed kinematic chains The same in open kinematic chains Isometric quadriceps exercises at full extension and 45-degree flexion

The second group (SR+I) followed the same standard protocol but also performed inertial exercises from the fifth week of rehabilitation. These exercises were conducted on an InerKnee setup, adapted from the Cyklotren device, and began four weeks post-surgery, provided the patient achieved at least 90 degrees of knee flexion (including full extension). The inertial exercises protocol included:

knee extension exercises performed in a seated position for the operated leg 4 sets of exercises, each lasting 15 seconds individually adjusted resistance to maintain a 1-second extension cycle passive rest periods of 2 minutes between sets

After 12 weeks of rehabilitation, effectiveness was evaluated using standard tests. The results showed that the innovative rehabilitation protocol, incorporating inertial exercises, can be effectively applied to patients following arthroscopic ACL reconstruction. No monitored indicators in the SR+I group were worse than those in the SR group. In fact, several parameters indicated the SR+I protocol's superiority over the standard protocol.

Conditions

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Anterior Cruciate Ligament Injury

Keywords

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ACL reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study finally included 24 people after ACL reconstruction. All of them participated in 12 - week rehabilitation; SR - standard rehabilitation, SR+I - standard rehabilitation and inertial exercises
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard rehabilitation

12 subjects after ACL reconstruction. Subjects participated in standard rehabilitation program twice a week for 12 weeks. Each session lasted approximately 60 minutes.

Group Type ACTIVE_COMPARATOR

Standard rehabilitaion after ACL reconstruction

Intervention Type OTHER

The SR group, consisting of 12 participants, underwent a standard rehabilitation program twice a week for 12 weeks. Each session lasted approximately 60 minutes and was conducted by the same therapist.

After 12 weeks of rehabilitation, effectiveness was evaluated using standard tests. Before rehabilitation involving kinesiotherapy (two weeks post-surgery), the following measurements were conducted:

Height and body weight Thigh circumference measurements Assessment of muscle and tendon stiffness Body composition evaluation

After the rehabilitation the following measurements and assessments were conducted:

Body weight Thigh circumference measurements Assessment of muscle and tendon stiffness Body composition evaluation Evaluation of the strength of knee extensor and flexor muscles under isokinetic conditions Evaluation of knee extensor strength under inertial conditions Postural stability assessment

Standard rehabilitaion after ACL reconstruction plus inertial exercises

Intervention Type OTHER

The SR+I group, consisting of 12 participants, underwent a standard rehabilitation program twice a week for 12 weeks including inertial exercises. Each session lasted approximately 70 minutes and was conducted by the same therapist.

Subjects also performed inertial exercises from the fifth week of rehabilitation. These exercises were conducted on an InerKnee. The inertial exercises protocol included: knee extension exercises performed in a seated position for the operated leg, 4 sets of exercises, each lasting 15 seconds individually, adjusted resistance to maintain a 1-second extension cycle, passive rest periods of 2 minutes between sets After 12 weeks of rehabilitation, effectiveness was evaluated using standard tests the same as in SR group.

Standard rehabilitation and inertial exercises

12 subjects after ACL reconstruction. Subjects participated in standard rehabilitation program twice a week for 12 weeks and additionally performed inertial exercises from the fifth week of rehabilitation. Then each session lasted approximately 70 minutes.

Group Type EXPERIMENTAL

Standard rehabilitaion after ACL reconstruction

Intervention Type OTHER

The SR group, consisting of 12 participants, underwent a standard rehabilitation program twice a week for 12 weeks. Each session lasted approximately 60 minutes and was conducted by the same therapist.

After 12 weeks of rehabilitation, effectiveness was evaluated using standard tests. Before rehabilitation involving kinesiotherapy (two weeks post-surgery), the following measurements were conducted:

Height and body weight Thigh circumference measurements Assessment of muscle and tendon stiffness Body composition evaluation

After the rehabilitation the following measurements and assessments were conducted:

Body weight Thigh circumference measurements Assessment of muscle and tendon stiffness Body composition evaluation Evaluation of the strength of knee extensor and flexor muscles under isokinetic conditions Evaluation of knee extensor strength under inertial conditions Postural stability assessment

Standard rehabilitaion after ACL reconstruction plus inertial exercises

Intervention Type OTHER

The SR+I group, consisting of 12 participants, underwent a standard rehabilitation program twice a week for 12 weeks including inertial exercises. Each session lasted approximately 70 minutes and was conducted by the same therapist.

Subjects also performed inertial exercises from the fifth week of rehabilitation. These exercises were conducted on an InerKnee. The inertial exercises protocol included: knee extension exercises performed in a seated position for the operated leg, 4 sets of exercises, each lasting 15 seconds individually, adjusted resistance to maintain a 1-second extension cycle, passive rest periods of 2 minutes between sets After 12 weeks of rehabilitation, effectiveness was evaluated using standard tests the same as in SR group.

Interventions

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Standard rehabilitaion after ACL reconstruction

The SR group, consisting of 12 participants, underwent a standard rehabilitation program twice a week for 12 weeks. Each session lasted approximately 60 minutes and was conducted by the same therapist.

After 12 weeks of rehabilitation, effectiveness was evaluated using standard tests. Before rehabilitation involving kinesiotherapy (two weeks post-surgery), the following measurements were conducted:

Height and body weight Thigh circumference measurements Assessment of muscle and tendon stiffness Body composition evaluation

After the rehabilitation the following measurements and assessments were conducted:

Body weight Thigh circumference measurements Assessment of muscle and tendon stiffness Body composition evaluation Evaluation of the strength of knee extensor and flexor muscles under isokinetic conditions Evaluation of knee extensor strength under inertial conditions Postural stability assessment

Intervention Type OTHER

Standard rehabilitaion after ACL reconstruction plus inertial exercises

The SR+I group, consisting of 12 participants, underwent a standard rehabilitation program twice a week for 12 weeks including inertial exercises. Each session lasted approximately 70 minutes and was conducted by the same therapist.

Subjects also performed inertial exercises from the fifth week of rehabilitation. These exercises were conducted on an InerKnee. The inertial exercises protocol included: knee extension exercises performed in a seated position for the operated leg, 4 sets of exercises, each lasting 15 seconds individually, adjusted resistance to maintain a 1-second extension cycle, passive rest periods of 2 minutes between sets After 12 weeks of rehabilitation, effectiveness was evaluated using standard tests the same as in SR group.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ACL reconstruction performed by the same doctor using similar technique, lack of other disases, minimum 90% attendance in rehabilitation sessions

Exclusion Criteria

* other chronic disases, rehabilitation was not completed, other injury during rehabilitation
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poznan University of Physical Education

OTHER

Sponsor Role collaborator

University in Zielona Góra

OTHER

Sponsor Role lead

Responsible Party

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Mariusz Naczk

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Physical Education and Sport, Faculty in Gorzow Wielkopolski, Poznan University of Physical Education, Poznan, Poland

Gorzów Wielkopolski, , Poland

Site Status

Countries

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Poland

Other Identifiers

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University of Zielona Gora

Identifier Type: -

Identifier Source: org_study_id