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The Effectıveness Of Structured Myofascial Chain Exercise Training After Anterior Cruciate Ligament Reconstruction

Primary Purpose

Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise Therapy For Lower Extremities
Exercise Therapy For Myofascial Chains
Sponsored by
Bahçeşehir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injuries focused on measuring Tele-Health, Sports injuries, Anterior Cruciate Ligament, Reconstruction, Exercise, Physical Therapy And Rehabilitation

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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 10 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

Sites / Locations

  • Istanbul University-Cerrahpasa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Exercise Therapy For Lower Extremities

Exercise Therapy For Myofascial Chains

Control Group

Arm Description

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 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 will do any exercises. They will join only assessment sessions.

Outcomes

Primary Outcome Measures

IKDC (International Knee Documentation Committee) Subjective Knee Score change is being assessed.
Self-Reported measure score was recorded with higher scores mean better outcomes.

Secondary Outcome Measures

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.
Flexibility change is being assessed.
Sit and Reach Test was performed for three times. Maximum value of reaching in cm were recorded.
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.
Dynamic balance change is being assessed.
Y Balance Test were performed for three times. Maximum value of reaching in cm were recorded.
Performance change is being assessed.
Repeated sitting and stepping moves in 30 seconds were performed for three times. Maximum number of moves were recorded.
Lysholm Knee Score change is being assessed.
Self-Reported measure score was recorded with higher scores mean better outcomes.
Knee injury and Osteoarthritis Outcome Score
Self-Reported measure score was recorded with higher scores mean better outcomes.
Tampa Kinesiophobia
Self-Reported measure score was recorded with lower scores mean better outcomes.

Full Information

First Posted
December 8, 2021
Last Updated
September 21, 2023
Sponsor
Bahçeşehir University
Collaborators
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05423184
Brief Title
The Effectıveness Of Structured Myofascial Chain Exercise Training After Anterior Cruciate Ligament Reconstruction
Official Title
The Effectıveness Of Structured Myofascial Chain Exercise Training After Anterior Cruciate Ligament Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
August 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bahçeşehir University
Collaborators
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective Randomize Controlled Study
Masking
Participant
Masking Description
Knowledge that which exercises are structured for research will keep from participants.
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Therapy For Lower Extremities
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Exercise Therapy For Myofascial Chains
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants will do any exercises. They will join only assessment sessions.
Intervention Type
Other
Intervention Name(s)
Exercise Therapy For Lower Extremities
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise Therapy For Myofascial Chains
Intervention Description
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.
Primary Outcome Measure Information:
Title
IKDC (International Knee Documentation Committee) Subjective Knee Score change is being assessed.
Description
Self-Reported measure score was recorded with higher scores mean better outcomes.
Time Frame
Change from Baseline knee function at 6 week
Secondary Outcome Measure Information:
Title
Quadriceps Femoris and Hamstring muscle strength change is being assessed.
Description
Isometric muscle testing with digital hand held dynamometer was performed for three times. Maximum value of musle strenght in lbs were recorded.
Time Frame
Change from baseline knee strength at 6 week
Title
Flexibility change is being assessed.
Description
Sit and Reach Test was performed for three times. Maximum value of reaching in cm were recorded.
Time Frame
Change from Baseline flexibility at 6 week
Title
Static balance change is being assessed.
Description
Modified with flat ground flamingo balance test were performed for three times. Minimum number of faults in a minute were recorded.
Time Frame
Change from Baseline Balance at 6 week
Title
Dynamic balance change is being assessed.
Description
Y Balance Test were performed for three times. Maximum value of reaching in cm were recorded.
Time Frame
Change from Baseline Balance at 6 week
Title
Performance change is being assessed.
Description
Repeated sitting and stepping moves in 30 seconds were performed for three times. Maximum number of moves were recorded.
Time Frame
Change from Baseline Performance at 6 week
Title
Lysholm Knee Score change is being assessed.
Description
Self-Reported measure score was recorded with higher scores mean better outcomes.
Time Frame
Change from Baseline knee function at 6 week
Title
Knee injury and Osteoarthritis Outcome Score
Description
Self-Reported measure score was recorded with higher scores mean better outcomes.
Time Frame
Change from Baseline knee function at 6 week
Title
Tampa Kinesiophobia
Description
Self-Reported measure score was recorded with lower scores mean better outcomes.
Time Frame
Change from Baseline kinesiophobia function at 6 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effectıveness Of Structured Myofascial Chain Exercise Training After Anterior Cruciate Ligament Reconstruction

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