- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05423184
The Effectıveness Of Structured Myofascial Chain Exercise Training After Anterior Cruciate Ligament Reconstruction
September 21, 2023 updated by: Mirsad ALKAN, Bahçeşehir University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Istanbul, Turkey
- Istanbul University-Cerrahpasa
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Exercise Therapy For Lower Extremities
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.
|
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.
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Experimental: Exercise Therapy For Myofascial Chains
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. |
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.
|
No Intervention: Control Group
Participants will do any exercises.
They will join only assessment sessions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IKDC (International Knee Documentation Committee) Subjective Knee Score change is being assessed.
Time Frame: Change from Baseline knee function at 6 week
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Self-Reported measure score was recorded with higher scores mean better outcomes.
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Change from Baseline knee function at 6 week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quadriceps Femoris and Hamstring muscle strength change is being assessed.
Time Frame: Change from baseline knee strength at 6 week
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Isometric muscle testing with digital hand held dynamometer was performed for three times.
Maximum value of musle strenght in lbs were recorded.
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Change from baseline knee strength at 6 week
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Flexibility change is being assessed.
Time Frame: Change from Baseline flexibility at 6 week
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Sit and Reach Test was performed for three times.
Maximum value of reaching in cm were recorded.
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Change from Baseline flexibility at 6 week
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Static balance change is being assessed.
Time Frame: Change from Baseline Balance at 6 week
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Modified with flat ground flamingo balance test were performed for three times.
Minimum number of faults in a minute were recorded.
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Change from Baseline Balance at 6 week
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Dynamic balance change is being assessed.
Time Frame: Change from Baseline Balance at 6 week
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Y Balance Test were performed for three times.
Maximum value of reaching in cm were recorded.
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Change from Baseline Balance at 6 week
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Performance change is being assessed.
Time Frame: Change from Baseline Performance at 6 week
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Repeated sitting and stepping moves in 30 seconds were performed for three times.
Maximum number of moves were recorded.
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Change from Baseline Performance at 6 week
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Lysholm Knee Score change is being assessed.
Time Frame: Change from Baseline knee function at 6 week
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Self-Reported measure score was recorded with higher scores mean better outcomes.
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Change from Baseline knee function at 6 week
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Knee injury and Osteoarthritis Outcome Score
Time Frame: Change from Baseline knee function at 6 week
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Self-Reported measure score was recorded with higher scores mean better outcomes.
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Change from Baseline knee function at 6 week
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Tampa Kinesiophobia
Time Frame: Change from Baseline kinesiophobia function at 6 week
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Self-Reported measure score was recorded with lower scores mean better outcomes.
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Change from Baseline kinesiophobia function at 6 week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Actual)
June 30, 2023
Study Completion (Actual)
August 15, 2023
Study Registration Dates
First Submitted
December 8, 2021
First Submitted That Met QC Criteria
June 14, 2022
First Posted (Actual)
June 21, 2022
Study Record Updates
Last Update Posted (Actual)
September 25, 2023
Last Update Submitted That Met QC Criteria
September 21, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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