- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07328139
Effects of Core Exercises on Balance in People With and Without ACL Surgery
Comparison of the Effects of Core Stabilization Exercises on Balance and Trunk Endurance in Individuals With Anterior Cruciate Ligament Reconstruction Surgery and Healthy Individuals.
The main purpose of this study is to evaluate and compare the effects of an 8-week core stabilization exercise program on balance, trunk muscle endurance, and lower body strength.
The study includes two groups of participants: 15 individuals who have had Anterior Cruciate Ligament (ACL) reconstruction surgery and 15 healthy individuals. Both groups will perform the same core stabilization exercises for 8 weeks, twice a week, under the supervision of a physiotherapist.
The goal is to determine if this exercise program improves balance and core strength in people who have had ACL surgery and to compare these results with those of healthy individuals performing the same exercises.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Fatih
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Istanbul, Fatih, Turkey (Türkiye), 34093
- Bezmialem Vakif University Faculty of Medicine Hospital, Department of Physical Medicine and Rehabilitation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Aged between 18 and 65 years.
- Agreement to participate regularly in the 8-week exercise program.
- No contraindications to physical activity, as assessed by a medical professional.
- ACLR group: history of unilateral ACL reconstruction within the past five years.
- Control group: no known history of lower extremity injury or surgery.
Exclusion Criteria
- Any musculoskeletal or neurological condition affecting balance or core stabilization.
- Participation in a structured core stabilization exercise program within the previous six months.
- Any acute injury or systemic disease that may interfere with study participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ACL Reconstruction Group
Participants in this arm are individuals who have undergone unilateral Anterior Cruciate Ligament (ACL) reconstruction surgery within the last 5 years.
These participants will receive a core stabilization exercise program for 8 weeks, with supervised sessions held twice per week.
The exercise program includes movements such as the Hundreds, clam exercise, plank, side plank, dead bug, and bridging.
|
Participants receive a supervised core stabilization exercise program for a duration of 8 weeks.
Sessions are conducted twice per week by a physiotherapist.
The program includes a set of standardized exercises such as the Hundreds, clam exercise, plank, side plank, dead bug exercise, curl-ups, and bridging.
|
|
Active Comparator: Healthy Control Group
Participants in this arm are healthy individuals with no known history of lower extremity injury or surgery.
This group is matched to the ACL Reconstruction Group.
These participants will also receive the same core stabilization exercise program for 8 weeks, with supervised sessions held twice per week, to serve as a comparison group.
|
Participants receive a supervised core stabilization exercise program for a duration of 8 weeks.
Sessions are conducted twice per week by a physiotherapist.
The program includes a set of standardized exercises such as the Hundreds, clam exercise, plank, side plank, dead bug exercise, curl-ups, and bridging.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Dynamic Balance as Measured by the Y-Balance Test
Time Frame: Baseline and 8 weeks
|
The Y-Balance Test (YBT) is used to assess dynamic postural control.
Participants stand on one leg at the center of a grid and reach with the other leg as far as possible in three directions: anterior, posteromedial, and posterolateral.
The maximum reach distance in each direction is recorded in centimeters.
A higher score indicates better dynamic balance.
|
Baseline and 8 weeks
|
|
Change in Trunk Muscle Endurance as Measured by the McGill Core Endurance Tests
Time Frame: Baseline and 8 weeks
|
Trunk muscle endurance is assessed using the McGill Core Endurance Test battery, which consists of four tests: a trunk flexor endurance test, a trunk extensor endurance test (Sorenson test), and right and left lateral trunk muscle endurance tests (side bridge).
The time in seconds that a participant can hold each specific position without losing the correct form is recorded.
A longer time indicates greater endurance.
|
Baseline and 8 weeks
|
Collaborators and Investigators
Sponsor
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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2023/361
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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