Anterior Cruciate Ligament InjuriesNCT05423184
The Effectıveness Of Structured Myofascial Chain Exercise Training After Anterior Cruciate Ligament Reconstruction
A study testing Exercise Therapy For Lower Extremities and Exercise Therapy For Myofascial Chains in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
Anterior cruciate ligament reconstruction(ACLR) surgery accepts best choices which condicions are totaly ruptured ACL or partial ruputures when patients with high activity level. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
- What is being tested?
- Exercise Therapy For Lower Extremities and Exercise Therapy For Myofascial Chains
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 15 Aug 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between the ages of 18-45
- Being able to establish written and verbal communication in Turkish
- Post-Op rehabilitation after primary ACL surgery with Autograft in reconstruction, at 8 weeks, post op at 12 weeks at the latest.
- To have participated in an exercise-based rehabilitation program structured by a physiotherapist in the early and mid-term after surgery (a standardized program will not be applied in the early and mid-term, and participation in the study after rehabilitation is sufficient)
- Gaining full range of motion in the knee joint in the direction of extension, gaining full range of motion in the flexion direction with a maximum loss of 5 degrees
- BMI greater than 20 and less than 30
Show all 13Show fewer
- No previous history of surgery involving the lower extremity
- To be able to perform a normal gait pattern without compensatory movements
- m.Quadriceps Femoris Muscle strength of at least 60% of the healthy side
- Having an IKDC score of 55 or higher
- To have sufficient technological device usage skills and fast internet infrastructure to use video communication technologies without any problems.
- Having a device that provides the necessary equipment for video calling
- Having 15 m2 of space to allow exercise in the living area
Who cannot join
- Using allograft in reconstruction
- History of any chronic systemic, rheumatological, neurological, vascular disease
- History of traumatic injury to intact extremities and trunk in the last 6 months
- Presence of pain complaints including spine and shoulder pain over 3 according to the Visual Analogue Scale
- Those who use anti-inflammatory drugs
- Presence of cognitive or psychological illness that will prevent cooperation
Trial locations and contacts
1 site in 1 country.
About this study
Anterior cruciate ligament reconstruction(ACLR) surgery accepts best choices which condicions are totaly ruptured ACL or partial ruputures when patients with high activity level. Rehabilitation after ACL is an indispensable element of treatment because ACL injury causes severe instability and early degenerative changes in the knee. Although there is no standard rehabilitation program after ACLR but the concept of "Functional Rehabilitation" is prefers nowadays which structred according to therapeutic goals, it is planned in three stages as early, mid-term and late-term. After the late-term goals are achieved safely and the individuals reach to needed criterias, the stage of returning to sports or activity is planned. Patients with an active life expectancy, the goal at the end of rehabilitation after ACLR is to return to activity or sports and to reach pre-injury performance. Most individuals fail to return to sports or activity after ACL due to long-term strength deficits, neuromuscular and biomechanical changes, knee instability, and early developing knee osteoarthritis. Addition to that; changes that affect both the knee joint and the whole body biomechanics occur even in individuals who successfully return to activity and sports after ACL. Although there are problems that affect the whole body by exceeding a single segment in rehabilitation after ACLR; there is no study using the myofascial chain exercises approach in the treatment of these problems. Hip, core or trunk stabilization exercises and neuromuscular trainings that include more than one body segment added to the ACLR program provides more positive effects on rehabilitation outcomes than regional applications. In this project, researches aim to investigate that the effectiveness of structured myofascial chain exercises training, which will be applied in the late period of rehabilitation after ACLR, on functionality, performance and participation.In project scope; After completing the early and mid-term rehabilitation after surgery, the volunteers who met the criteria for transition to late rehabilitation were divided into two groups; lower extremity exercise training will be given to the first group and myofascial chain exercise training will be given to the second group. The control group will consist of healthy volunteers. In addition to the control group; The operated and intact extremities of the volunteers in the experimental groups will be compared. The training session, in which preterm and postterm evaluations and the exercises are taught, will be carried out with the face-to-face method, and the ongoing exercise sessions will be carried out with the telerehabilitation method. Reasearch outcome measures will be evaluated with strength, flexibility, balance, endurance, activity performance against time measurements and self-assessment questionnaires. End of this project; important data will be obtained in the fight against the risks created by the deficits that continue after the ACLR. The deficits seen after ACL fails to individuals from returning to their pre-injury functional level; the desired success cannot be achieved in returning to work, returning to sports, and returning to activity. Due to this situation, which poses a global problem, even if there is a return to work or sports after injury, branch and job changes may be required and the desired level of performance cannot be achieved. In individuals who cannot return to activity, inactive life increases the risk of non-communicable chronic diseases as well as the increased risk of osteoarthritis. In case of success in the project, important information will be obtained in order to prevent both the quality of life and the cost of secondary health and social life problems associated with ACL injuries. The content of the program will be expanded to include other sports injuries by applying to follow-up projects for the registration of the method to be applied for the first time.
- Conditions
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
- Being tested
- Exercise Therapy For Lower Extremities, Exercise Therapy For Myofascial Chains
- Keywords
- Tele-Health, Sports injuries, Anterior Cruciate Ligament, Reconstruction, Exercise, Physical Therapy And Rehabilitation
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Athletic Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Therapy For Lower ExtremitiesOther
Participants who have inclusion criterias after ACL reconstrontion pos-op 8. week will included this study. Certified Physiotherapist who have master of science degree and doctorate student will assessed them before and after treatment with face to face. Also exercise education will give face to face with same therapist. After that first sessions patients will progress their standardize exercises pragram with telerehabilition during 6 weeks and 18 sessions. This program includes four directions single leg raise with theraband, squat, lunge walk and static balance exercises. All sessions will be supervised with physiotherapist. End of study assessments will perform again with same therapist.
Exercise Therapy For Myofascial ChainsOther
Participants who have inclusion criterias after ACL reconstrontion pos-op 8. week will included this study. Certified Physiotherapist who have master of science degree and doctorate student will assessed them before and after treatment with face to face. Also exercise education will give face to face with same therapist. After that first sessions patients will progress their structered exercises pragram with telerehabilition during 6 weeks and 18 sessions. This program includes four directions single leg and arm raise with theraband, squat with arm participation using theraband, lunge walk with arm participation using theraband and static balance exercises with arm participation using theraband. All sessions will be supervised with physiotherapist. End of study assessments will perform again with same therapist.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Therapy For Lower Extremities | Active comparator | Participants will treated exercises with focused on lower extremities especilly knee joint and muscles. Exercise program continue for 18 sessions with 3 times a week and 6 week duration. Exercises are; straight leg raise, assisted squat, lunge. All sessions supervised by a physiotherapist with synchron tele-rehabilitation. Receives: Other: Exercise Therapy For Lower Extremities |
| Exercise Therapy For Myofascial Chains | Experimental | Participants will treated exercises with focused on whole body especilly myofascial chains.
Exercise program continue for 18 sessions with 3 times a week and 6 week duration. Exercises are; straight leg raise, assisted squat, lunge with upper extremities and whole body participation. All sessions supervised by a physiotherapist with synchron tele-rehabilitation. Receives: Other: Exercise Therapy For Myofascial Chains |
| Control Group | No intervention | Participants will do any exercises. They will join only assessment sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IKDC (International Knee Documentation Committee) Subjective Knee Score change is being assessed.
Self-Reported measure score was recorded with higher scores mean better outcomes.
Measured: Change from Baseline knee function at 6 week
Secondary outcomes (8)
Quadriceps Femoris and Hamstring muscle strength change is being assessed.
Isometric muscle testing with digital hand held dynamometer was performed for three times. Maximum value of musle strenght in lbs were recorded.
Measured: Change from baseline knee strength at 6 week
Flexibility change is being assessed.
Sit and Reach Test was performed for three times. Maximum value of reaching in cm were recorded.
Measured: Change from Baseline flexibility at 6 week
Static balance change is being assessed.
Modified with flat ground flamingo balance test were performed for three times. Minimum number of faults in a minute were recorded.
Measured: Change from Baseline Balance at 6 week
Dynamic balance change is being assessed.
Y Balance Test were performed for three times. Maximum value of reaching in cm were recorded.
Measured: Change from Baseline Balance at 6 week
Performance change is being assessed.
Repeated sitting and stepping moves in 30 seconds were performed for three times. Maximum number of moves were recorded.
Measured: Change from Baseline Performance at 6 week
Lysholm Knee Score change is being assessed.
Self-Reported measure score was recorded with higher scores mean better outcomes.
Measured: Change from Baseline knee function at 6 week
Knee injury and Osteoarthritis Outcome Score
Self-Reported measure score was recorded with higher scores mean better outcomes.
Measured: Change from Baseline knee function at 6 week
Tampa Kinesiophobia
Self-Reported measure score was recorded with lower scores mean better outcomes.
Measured: Change from Baseline kinesiophobia function at 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Jan 2022
- Primary completion30 Jun 2023
- Study completion15 Aug 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 InjuriesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomize Controlled Study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Mirsad ALKAN, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423184
- Sponsor's protocol ID
- 2023
- Status last verified
- Sep 2023
- First submitted
- 8 Dec 2021
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectıveness Of Structured Myofascial Chain Exercise Training After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT05423184
- Acronym / sponsor ID
- 2023
- Conditions
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
- Keywords
- Tele-Health, Sports injuries, Anterior Cruciate Ligament, Reconstruction, Exercise, Physical Therapy And Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 21 Jun 2022 (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.
Anterior cruciate ligament reconstruction(ACLR) surgery accepts best choices which condicions are totaly ruptured ACL or partial ruputures when patients with high activity level. Rehabilitation after ACL is an indispensable element of treatment because ACL injury causes severe instability and early degenerative changes in the knee. Although there is no standard rehabilitation program after ACLR but the concept of "Functional Rehabilitation" is prefers nowadays which structred according to therapeutic goals, it is planned in three stages as early, mid-term and late-term. After the late-term goals are achieved safely and the individuals reach to needed criterias, the stage of returning to sports or activity is planned. Patients with an active life expectancy, the goal at the end of rehabilitation after ACLR is to return to activity or sports and to reach pre-injury performance. Most individuals fail to return to sports or activity after ACL due to long-term strength deficits, neuromuscular and biomechanical changes, knee instability, and early developing knee osteoarthritis. Addition to that; changes that affect both the knee joint and the whole body biomechanics occur even in individuals who successfully return to activity and sports after ACL. Although there are problems that affect the whole body by exceeding a single segment in rehabilitation after ACLR; there is no study using the myofascial chain exercises approach in the treatment of these problems. Hip, core or trunk stabilization exercises and neuromuscular trainings that include more than one body segment added to the ACLR program provides more positive effects on rehabilitation outcomes than regional applications. In this project, researches aim to investigate that the effectiveness of structured myofascial chain exercises training, which will be applied in the late period of rehabilitation after ACLR, on functionality, performance and participation.In project scope; After completing the early and mid-term rehabilitation after surgery, the volunteers who met the criteria for transition to late rehabilitation were divided into two groups; lower extremity exercise training will be given to the first group and myofascial chain exercise training will be given to the second group. The control group will consist of healthy volunteers. In addition to the control group; The operated and intact extremities of the volunteers in the experimental groups will be compared. The training session, in which preterm and postterm evaluations and the exercises are taught, will be carried out with the face-to-face method, and the ongoing exercise sessions will be carried out with the telerehabilitation method. Reasearch outcome measures will be evaluated with strength, flexibility, balance, endurance, activity performance against time measurements and self-assessment questionnaires. End of this project; important data will be obtained in the fight against the risks created by the deficits that continue after the ACLR. The deficits seen after ACL fails to individuals from returning to their pre-injury functional level; the desired success cannot be achieved in returning to work, returning to sports, and returning to activity. Due to this situation, which poses a global problem, even if there is a return to work or sports after injury, branch and job changes may be required and the desired level of performance cannot be achieved. In individuals who cannot return to activity, inactive life increases the risk of non-communicable chronic diseases as well as the increased risk of osteoarthritis. In case of success in the project, important information will be obtained in order to prevent both the quality of life and the cost of secondary health and social life problems associated with ACL injuries. The content of the program will be expanded to include other sports injuries by applying to follow-up projects for the registration of the method to be applied for the first time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Prospective Randomize Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Exercise Therapy For Lower Extremities | Active comparator | Other: Exercise Therapy For Lower ExtremitiesParticipants will treated exercises with focused on lower extremities especilly knee joint and muscles. Exercise program continue for 18 sessions with 3 times a week and 6 week duration. Exercises are; straight leg raise, assisted squat, lunge. All sessions supervised by a physiotherapist with synchron tele-rehabilitation. |
| Exercise Therapy For Myofascial Chains | Experimental | Other: Exercise Therapy For Myofascial ChainsParticipants will treated exercises with focused on whole body especilly myofascial chains. Exercise program continue for 18 sessions with 3 times a week and 6 week duration. Exercises are; straight leg raise, assisted squat, lunge with upper extremities and whole body participation. All sessions supervised by a physiotherapist with synchron tele-rehabilitation. |
| Control Group | No intervention | –Participants will do any exercises. They will join only assessment sessions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Being between the ages of 18-45
- Being able to establish written and verbal communication in Turkish
- Post-Op rehabilitation after primary ACL surgery with Autograft in reconstruction, at 8 weeks, post op at 12 weeks at the latest.
- To have participated in an exercise-based rehabilitation program structured by a physiotherapist in the early and mid-term after surgery (a standardized program will not be applied in the early and mid-term, and participation in the study after rehabilitation is sufficient)
- Gaining full range of motion in the knee joint in the direction of extension, gaining full range of motion in the flexion direction with a maximum loss of 5 degrees
Key exclusion criteria (6 listed)
- Using allograft in reconstruction
- History of any chronic systemic, rheumatological, neurological, vascular disease
- History of traumatic injury to intact extremities and trunk in the last 6 months
- Presence of pain complaints including spine and shoulder pain over 3 according to the Visual Analogue Scale
- Those who use anti-inflammatory drugs
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 |
|---|---|---|
| Exercise Therapy For Lower ExtremitiesParticipants who have inclusion criterias after ACL reconstrontion pos-op 8. week will included this study. Certified Physiotherapist who have master of science degree and doctorate student will assessed them before and after treatment with face to face. Also exercise education will give face to face with same therapist. After that first sessions patients will progress their standardize exercises pragram with telerehabilition during 6 weeks and 18 sessions. This program includes four directions single leg raise with theraband, squat, lunge walk and static balance exercises. All sessions will be supervised with physiotherapist. End of study assessments will perform again with same therapist. | Other | Exercise Therapy For Lower Extremities |
| Exercise Therapy For Myofascial ChainsParticipants who have inclusion criterias after ACL reconstrontion pos-op 8. week will included this study. Certified Physiotherapist who have master of science degree and doctorate student will assessed them before and after treatment with face to face. Also exercise education will give face to face with same therapist. After that first sessions patients will progress their structered exercises pragram with telerehabilition during 6 weeks and 18 sessions. This program includes four directions single leg and arm raise with theraband, squat with arm participation using theraband, lunge walk with arm participation using theraband and static balance exercises with arm participation using theraband. All sessions will be supervised with physiotherapist. End of study assessments will perform again with same therapist. | Other | Exercise Therapy For Myofascial Chains |
Primary outcome
IKDC (International Knee Documentation Committee) Subjective Knee Score change is being assessed.
Time frame: Change from Baseline knee function at 6 week
Self-Reported measure score was recorded with higher scores mean better outcomes.
8 secondary outcomes
Quadriceps Femoris and Hamstring muscle strength change is being assessed.
Time frame: Change from baseline knee strength at 6 week
Flexibility change is being assessed.
Time frame: Change from Baseline flexibility at 6 week
Static balance change is being assessed.
Time frame: Change from Baseline Balance at 6 week
Dynamic balance change is being assessed.
Time frame: Change from Baseline Balance at 6 week
Performance change is being assessed.
Time frame: Change from Baseline Performance at 6 week
Lysholm Knee Score change is being assessed.
Time frame: Change from Baseline knee function at 6 week
Knee injury and Osteoarthritis Outcome Score
Time frame: Change from Baseline knee function at 6 week
Tampa Kinesiophobia
Time frame: Change from Baseline kinesiophobia function at 6 week
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 25 Sep 2023.
- Individual participant dataSharing planned: No
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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 Exercise Therapy For Lower Extremities and Exercise Therapy For Myofascial Chains in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
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 13 inclusion and 6 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 25 Sep 2023. 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 Turkey (Türkiye). 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?
IKDC (International Knee Documentation Committee) Subjective Knee Score change is being assessed. (time frame: Change from Baseline knee function at 6 week). 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 25 Sep 2023.