Anterior Cruciate Ligament InjuryNCT06726044
Effectiveness of Rehabilitation After Arthroscopic ACL Reconstruction Using Inertial Exercises
A study testing Standard rehabilitaion after ACL reconstruction and Standard rehabilitaion after ACL reconstruction plus inertial exercises in people with Anterior Cruciate Ligament Injury, run by University in Zielona Góra at 1 site in Poland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- Standard rehabilitaion after ACL reconstruction and Standard rehabilitaion after ACL reconstruction plus inertial exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePoland
- Study dates
- 2 Apr 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ACL reconstruction performed by the same doctor using similar technique, lack of other disases, minimum 90% attendance in rehabilitation sessions
Who cannot join
- other chronic disases, rehabilitation was not completed, other injury during rehabilitation
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Physical Education and Sport, Faculty in Gorzow Wielkopolski, Poznan University of Physical Education, Poznan, Poland
Gorzów Wielkopolski, 66-400
About this study
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
Read more
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- Standard rehabilitaion after ACL reconstruction, Standard rehabilitaion after ACL reconstruction plus inertial exercises
- Keywords
- ACL reconstruction
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard rehabilitaion after ACL reconstructionOther
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 exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard rehabilitation | Active comparator | 12 subjects after ACL reconstruction. Subjects participated in standard rehabilitation program twice a week for 12 weeks. Each session lasted approximately 60 minutes. Receives: Other: Standard rehabilitaion after ACL reconstruction; Other: Standard rehabilitaion after ACL reconstruction plus inertial exercises |
| Standard rehabilitation and inertial exercises | Experimental | 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. Receives: Other: Standard rehabilitaion after ACL reconstruction; Other: Standard rehabilitaion after ACL reconstruction plus inertial exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee extensors anf flexors strength under isokinetic and inertial conditions.
After 12 weeks of rehabilitation, muscle strength was assessed in all patients under isokinetic and inertial conditions. Measurements were conducted following these guidelines:
- Isokinetic measurements at two speeds: of 60˚/s, and 180˚/s, with five repetitions of flexion and extension for each limb and each speed in a seated position,
- the axis of rotation of the dynamometer was aligned with the axis of rotation of the knee joint.
- patients performed trial repetitions to familiarize themselves with the movement speed and range of motion. the range of motion was consistently set at 60˚, starting from a knee flexion angle of 90˚ ± 30˚.
- patients were secured using crossed straps, a hip belt, and a limb-specific belt.
- only the patient and the examiner are allowed in the room during the measurement process
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
Measured: 12 weeks of rehabilitation
Secondary outcomes (1)
Body balance, stability and mobility after 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:
- positioning: the participant stands on a designated mark with one foot (the tested limb), which serves as the base and starting point for all three arms of the Y-shape scale. The opposite foot (non-tested limb) is used to reach as far as possible along the measurement arms of the Y.
- testing directions: Anterior Posterolateral Posteromedial
- rules: the foot of the reaching limb must not bear weight or touch the floor forcefully. The arms must stay positioned on the hips during the entire test. Loss of balance, ground contact with the reaching foot, or incorrect arm positioning invalidates the trial
- execution: the participant performs three attempts for each direction. The farthest distance reached in each direction is recorded.
Measured: 12 weeks of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start2 Apr 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University in Zielona Góra
- Sponsor type
- University, hospital or other
- Collaborators
- Poznan University of Physical Education
- Responsible party
- Principal investigator, Mariusz Naczk, University in Zielona Góra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726044
- Sponsor's protocol ID
- University of Zielona Gora
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data from research excluding private data; names etc.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Rehabilitation After Arthroscopic ACL Reconstruction Using Inertial Exercises
- ClinicalTrials.gov ID
- NCT06726044
- Acronym / sponsor ID
- University of Zielona Gora
- Conditions
- Anterior Cruciate Ligament Injury
- Keywords
- ACL reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University in Zielona GóraUniversity, hospital or other
- Collaborators
- Poznan University of Physical Education
- Study start
- 2 Apr 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Standard rehabilitation | Active comparator | Other: Standard rehabilitaion after ACL reconstruction, Other: Standard rehabilitaion after ACL reconstruction plus inertial exercises12 subjects after ACL reconstruction. Subjects participated in standard rehabilitation program twice a week for 12 weeks. Each session lasted approximately 60 minutes. |
| Standard rehabilitation and inertial exercises | Experimental | Other: Standard rehabilitaion after ACL reconstruction, Other: Standard rehabilitaion after ACL reconstruction plus inertial exercises12 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ACL reconstruction performed by the same doctor using similar technique, lack of other disases, minimum 90% attendance in rehabilitation sessions
Key exclusion criteria (1 listed)
- other chronic disases, rehabilitation was not completed, other injury during rehabilitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard rehabilitaion after ACL reconstructionThe 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 | Other | Standard rehabilitation, Standard rehabilitation and inertial exercises |
| Standard rehabilitaion after ACL reconstruction plus inertial exercisesThe 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. | Other | Standard rehabilitation, Standard rehabilitation and inertial exercises |
Primary outcome
Knee extensors anf flexors strength under isokinetic and inertial conditions.
Time frame: 12 weeks of rehabilitation
After 12 weeks of rehabilitation, muscle strength was assessed in all patients under isokinetic and inertial conditions. Measurements were conducted following these guidelines: * Isokinetic measurements at two speeds: of 60˚/s, and 180˚/s, with five repetitions of flexion and extension for each limb and each speed in a seated position, * the axis of rotation of the dynamometer was aligned with the axis of rotation of the knee joint. * patients performed trial repetitions to familiarize themselves with the movement speed and range of motion. the range of motion was consistently set at 60˚, starting from a knee flexion angle of 90˚ ± 30˚. * patients were secured using crossed straps, a hip belt, and a limb-specific belt. * only the patient and the examiner are allowed in the room during the measurement process 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
1 secondary outcome
Body balance, stability and mobility after rehabilitation
Time frame: 12 weeks of rehabilitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: Yes. All data from research excluding private data; names etc.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard rehabilitaion after ACL reconstruction and Standard rehabilitaion after ACL reconstruction plus inertial exercises in people with Anterior Cruciate Ligament Injury, run by University in Zielona Góra at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee extensors anf flexors strength under isokinetic and inertial conditions. (time frame: 12 weeks of rehabilitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.