- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06726044
Effectiveness of Rehabilitation After Arthroscopic ACL Reconstruction Using Inertial Exercises
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gorzow Wielkopolski, Poland, 66-400
- Department of Physical Education and Sport, Faculty in Gorzow Wielkopolski, Poznan University of Physical Education, Poznan, Poland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
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 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. |
|
Experimental: 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.
|
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 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee extensors anf flexors strength under isokinetic and inertial conditions.
Time Frame: 12 weeks of rehabilitation
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After 12 weeks of rehabilitation, muscle strength was assessed in all patients under isokinetic and inertial conditions. Measurements were conducted following these guidelines:
the range of motion was consistently set at 60˚, starting from a knee flexion angle of 90˚ ± 30˚.
The patient's arms were crossed on the chest during the measurement. Testing began with the healthy limb and concluded with the operated limb. Patients |
12 weeks of rehabilitation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body balance, stability and mobility after rehabilitation
Time Frame: 12 weeks of rehabilitation
|
Y-Balance Test - Examination Description The Y-Balance Test is a dynamic balance assessment tool used to evaluate an individual's postural control and stability. Here's the procedure:
|
12 weeks of rehabilitation
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- University of Zielona Gora
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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