- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05484778
Analysis of Balance and Functional Hop Tests in Athletes With Lower Extremity Injuries by Dual Task Study
Functional Hop tests and balance measurements are frequently used to decide on returning to sports after lower extremity injuries. Although the athletes show proficiency in these tests and measurements, re-injuries occur when returning to sports. The causes of these re-injuries are mostly functional deficiencies such as inadequate neuromuscular control and stability.
In the competition or sports environment, especially in team games, the athlete also shows cognitive performance, such as communication with teammates and following the game, which are included in the game setup, as well as the physical performance. Performing many tasks or performances at the same time divides the focus of attention on the activities performed, and if the person cannot adequately meet the attention demands, the quality of one or more of the tasks performed will deteriorate. As the level of expertise in the sport increases, the athlete tends to manage his posture, balance and movement with automatic postural control and can focus his attention on a new task.
The concept of focus of attention has been evaluated from different perspectives over time. If it is examined in terms of direction; It is divided into two as the internal focus of attention, which is used by focusing on body movements during the performance of the person, and the external focus of attention, which is used by focusing on the effect of the movement during the performance of the person. As the investigators planned in this study, a second cognitive task assigned to the participant simultaneously during his or her physical performance acts as an external focus of attention, allowing movement control during performance to be carried out by unconscious or automatic processes.
The investigators's aim; It is to examine the balance and functional hop tests that the investigator will apply in athletes by combining them with a simultaneous dual cognitive task that will reflect the field conditions more realistically. In the meantime, investigators think that with the sharing of our results with the literature, it can contribute to both the decision-making processes to return to sports after injury and preventive rehabilitation programs.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Fatih
-
Istanbul, Fatih, Turkey
- Istanbul University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having a history of injury to only one lower extremity before
- Having to stay away from sports activities for at least 1 week and maximum 6 weeks after the injury.
- Not having a lower extremity injury in the last 6 months
- Age range of 14-30 and still being active at high school or university level in sports involving sudden changes of direction and jumping physically
Exclusion Criteria:
- Bilateral lower extremity injury history
- Pregnancy
- Vestibular, respiratory and visual disturbances
- Diabetes
- Auditory or cognitive deficit
- Use of drugs that affect balance, cognition and attention
- Pain in the affected lower extremity (at least 2/10 according to the VAS -Visual Analogue Scale-)
- Lower extremity or waist operation history
- Conditions or neurological disorders that may affect balance
- Head trauma or symptoms related to head trauma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Case Group
This group consists of athletes whose are between the ages of 14-30 and are still active at high school or university level in sports involving sudden changes of direction and jump physically and who have a history of injury to only one lower extremity before.
|
The dual task methodology is a testing model that requires one person to perform two tasks at the same time.
The dual task is divided into two as motor-motor or motor-cognitive.
Dual tasks provide an opportunity to examine the attention demands of both tasks and allow possible interference to be observed.
The idea behind this design is that central processing capacity has a limit and must be distributed among concurrent tasks.
|
|
Other: Control Group
This group consists of athletes whose age range is 14-30, and who are still active at high school or university level in sports involving sudden changes of direction and jump physically and who do not have a history of lower extremity injuries.
|
The dual task methodology is a testing model that requires one person to perform two tasks at the same time.
The dual task is divided into two as motor-motor or motor-cognitive.
Dual tasks provide an opportunity to examine the attention demands of both tasks and allow possible interference to be observed.
The idea behind this design is that central processing capacity has a limit and must be distributed among concurrent tasks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance Performance Measurement (OSI-injured/Worse Side-Single Task)
Time Frame: day 1
|
For balance measurement, Athlete Single Leg Stability, one of the test modes in the Biodex Balance System SD balance device, was preferred. The participant took a position with her/his eyes open, the foot of the untested leg resting on the back of the ankle of the tested leg, her arms crossed over her chest, and the balance center in the middle of the platform most comfortably. The analysis protocol was applied at 5 level, consisting of 20 seconds, 1 sample and 3 test repetitions, with a 10-second rest between repetitions. General stability index (OSI), anterior/posterior stability index (APSI), medial/lateral stability index (MLSI) were recorded. The unit of data obtained in this device is the balance index. And values close to 0 indicate high stability. |
day 1
|
|
Balance Performance Measurement (APSI-injured/Worse Side-Single Task)
Time Frame: day 1
|
For balance measurement, Athlete Single Leg Stability, one of the test modes in the Biodex Balance System SD balance device, was preferred. The participant took a position with her/his eyes open, the foot of the untested leg resting on the back of the ankle of the tested leg, her arms crossed over her chest, and the balance center in the middle of the platform most comfortably. The analysis protocol was applied at 5 level, consisting of 20 seconds, 1 sample and 3 test repetitions, with a 10-second rest between repetitions. General stability index (OSI), anterior/posterior stability index (APSI), medial/lateral stability index (MLSI) were recorded. The unit of data obtained in this device is the balance index. And values close to 0 indicate high stability. |
day 1
|
|
Balance Performance Measurement (MLSI-injured/Worse Side-Single Task)
Time Frame: day 1
|
For balance measurement, Athlete Single Leg Stability, one of the test modes in the Biodex Balance System SD balance device, was preferred. The participant took a position with her/his eyes open, the foot of the untested leg resting on the back of the ankle of the tested leg, her arms crossed over her chest, and the balance center in the middle of the platform most comfortably. The analysis protocol was applied at 5 level, consisting of 20 seconds, 1 sample and 3 test repetitions, with a 10-second rest between repetitions. General stability index (OSI), anterior/posterior stability index (APSI), medial/lateral stability index (MLSI) were recorded. The unit of data obtained in this device is the balance index. And values close to 0 indicate high stability. |
day 1
|
|
Balance Performance Measurement (OSI-noninjured/Better Side-Single Task)
Time Frame: day 1
|
For balance measurement, Athlete Single Leg Stability, one of the test modes in the Biodex Balance System SD balance device, was preferred. The participant took a position with her/his eyes open, the foot of the untested leg resting on the back of the ankle of the tested leg, her arms crossed over her chest, and the balance center in the middle of the platform most comfortably. The analysis protocol was applied at 5 level, consisting of 20 seconds, 1 sample and 3 test repetitions, with a 10-second rest between repetitions. General stability index (OSI), anterior/posterior stability index (APSI), medial/lateral stability index (MLSI) were recorded. The unit of data obtained in this device is the balance index. And values close to 0 indicate high stability. |
day 1
|
|
Balance Performance Measurement (APSI-noninjured/Better Side- Single Task)
Time Frame: day 1
|
For balance measurement, Athlete Single Leg Stability, one of the test modes in the Biodex Balance System SD balance device, was preferred. The participant took a position with her/his eyes open, the foot of the untested leg resting on the back of the ankle of the tested leg, her arms crossed over her chest, and the balance center in the middle of the platform most comfortably. The analysis protocol was applied at 5 level, consisting of 20 seconds, 1 sample and 3 test repetitions, with a 10-second rest between repetitions. General stability index (OSI), anterior/posterior stability index (APSI), medial/lateral stability index (MLSI) were recorded. The unit of data obtained in this device is the balance index. And values close to 0 indicate high stability. |
day 1
|
|
Balance Measurement Performance (MLSI-noninjured/Better Side-Single Task)
Time Frame: day 1
|
For balance measurement, Athlete Single Leg Stability, one of the test modes in the Biodex Balance System SD balance device, was preferred. The participant took a position with her/his eyes open, the foot of the untested leg resting on the back of the ankle of the tested leg, her arms crossed over her chest, and the balance center in the middle of the platform most comfortably. The analysis protocol was applied at 5 level, consisting of 20 seconds, 1 sample and 3 test repetitions, with a 10-second rest between repetitions. General stability index (OSI), anterior/posterior stability index (APSI), medial/lateral stability index (MLSI) were recorded. The unit of data obtained in this device is the balance index. And values close to 0 indicate high stability. |
day 1
|
|
Functional Hop Test (THD-injured/Worse Side-Single Task)
Time Frame: day 1
|
Triple hop for distance ,Crossover hop for distance-CHD -In these two tests, the distance between the starting line and the heel line in step 3 was measured. Normalization was done by dividing this distance (m) by the athlete's height (m). The results of this measurement method have certain cut-off values depending on gender and age. In this study, the performance was not compared according to the cut-off values, but between the groups. |
day 1
|
|
Functional Hop Test (CHD-injured/Worse Side-Single Task)
Time Frame: day 1
|
Triple hop for distance ,Crossover hop for distance-CHD -In these two tests, the distance between the starting line and the heel line in step 3 was measured. Normalization was done by dividing this distance (m) by the athlete's height (m). The results of this measurement method have certain cut-off values depending on gender and age. In this study, the performance was not compared according to the cut-off values, but between the groups. |
day 1
|
|
Functional Hop Test (6MHT-injured/Worse Side-Single Task)
Time Frame: day 1
|
6m hop for timed-6MTH: The participant was asked to jump on one leg as fast as possible from the marked start point to the finish point, which is 6 meters away from the marked start point.
The time from the start to the end of 6 meters was recorded.
|
day 1
|
|
Functional Hop Test(THD-noninjured/Better Side- Single Task)
Time Frame: day 1
|
Triple hop for distance ,Crossover hop for distance-CHD -In these two tests, the distance between the starting line and the heel line in step 3 was measured.
Normalization was done by dividing this distance (m) by the athlete's height (m).
|
day 1
|
|
Functional Hop Test(CHD-noninjured/Better Side-Single Task)
Time Frame: day 1
|
Triple hop for distance ,Crossover hop for distance-CHD -In these two tests, the distance between the starting line and the heel line in step 3 was measured.
Normalization was done by dividing this distance (m) by the athlete's height (m).
|
day 1
|
|
Functional Hop Test(6MHT-noninjured/Better Side-Single Task)
Time Frame: day 1
|
6m hop for timed-6MTH: The participant was asked to jump on one leg as fast as possible from the marked start point to the finish point, which is 6 meters away from the marked start point.
The time from the start to the end of 6 meters was recorded.
|
day 1
|
|
Functional Hop Test THD LSI-Single Task
Time Frame: day 1
|
The limb symmetry index (LSI) was calculated to evaluate the difference between the two legs in all functional tests.
Calculation for the case group; LSI = Affected leg score ÷ Unaffected leg score × 100 This calculation for the control group; LSI= Worse score ÷ Better score × 100.
|
day 1
|
|
Functional Hop Test CHD LSI-Single Task
Time Frame: day 1
|
The limb symmetry index (LSI) was calculated to evaluate the difference between the two legs in all functional tests.
Calculation for the case group; LSI = Affected leg score ÷ Unaffected leg score × 100 This calculation for the control group; LSI= Worse score ÷ Better score × 100.
|
day 1
|
|
Functional Hop Test 6MHT LSI-Single Task
Time Frame: day 1
|
The limb symmetry index (LSI) was calculated to evaluate the difference between the two legs in all functional tests.
Calculation for the case group; LSI = Affected leg score ÷ Unaffected leg score × 100 This calculation for the control group; LSI= Worse score ÷ Better score × 100.
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance Performance Measurement (OSI-injured/Worse Side-Dual Task)
Time Frame: day 1
|
For balance measurement, Athlete Single Leg Stability, one of the test modes in the Biodex Balance System SD balance device, was preferred. The participant took a position with her/his eyes open, the foot of the untested leg resting on the back of the ankle of the tested leg, her arms crossed over her chest, and the balance center in the middle of the platform most comfortably. The analysis protocol was applied at 5 level, consisting of 20 seconds, 1 sample and 3 test repetitions, with a 10-second rest between repetitions. General stability index (OSI), anterior/posterior stability index (APSI), medial/lateral stability index (MLSI) were recorded. The unit of data obtained in this device is the balance index. And values close to 0 indicate high stability. |
day 1
|
|
Balance Performance Measurement (APSI-injured/Worse Side-Dual Task)
Time Frame: day 1
|
For balance measurement, Athlete Single Leg Stability, one of the test modes in the Biodex Balance System SD balance device, was preferred. The participant took a position with her/his eyes open, the foot of the untested leg resting on the back of the ankle of the tested leg, her arms crossed over her chest, and the balance center in the middle of the platform most comfortably. The analysis protocol was applied at 5 level, consisting of 20 seconds, 1 sample and 3 test repetitions, with a 10-second rest between repetitions. General stability index (OSI), anterior/posterior stability index (APSI), medial/lateral stability index (MLSI) were recorded. The unit of data obtained in this device is the balance index. And values close to 0 indicate high stability. |
day 1
|
|
Balance Performance Measurement (MLSI-injured/Worse Side-Dual Task)
Time Frame: day 1
|
For balance measurement, Athlete Single Leg Stability, one of the test modes in the Biodex Balance System SD balance device, was preferred. The participant took a position with her/his eyes open, the foot of the untested leg resting on the back of the ankle of the tested leg, her arms crossed over her chest, and the balance center in the middle of the platform most comfortably. The analysis protocol was applied at 5 level, consisting of 20 seconds, 1 sample and 3 test repetitions, with a 10-second rest between repetitions. General stability index (OSI), anterior/posterior stability index (APSI), medial/lateral stability index (MLSI) were recorded. The unit of data obtained in this device is the balance index. And values close to 0 indicate high stability. |
day 1
|
|
Balance Performance Measurement (OSI-noninjured/Better Side- Dual Task)
Time Frame: day 1
|
For balance measurement, Athlete Single Leg Stability, one of the test modes in the Biodex Balance System SD balance device, was preferred. The participant took a position with her/his eyes open, the foot of the untested leg resting on the back of the ankle of the tested leg, her arms crossed over her chest, and the balance center in the middle of the platform most comfortably. The analysis protocol was applied at 5 level, consisting of 20 seconds, 1 sample and 3 test repetitions, with a 10-second rest between repetitions. General stability index (OSI), anterior/posterior stability index (APSI), medial/lateral stability index (MLSI) were recorded. The unit of data obtained in this device is the balance index. And values close to 0 indicate high stability. |
day 1
|
|
Balance Performance Measurement(APSI-noninjured/Better Side-Dual Task)
Time Frame: day 1
|
For balance measurement, Athlete Single Leg Stability, one of the test modes in the Biodex Balance System SD balance device, was preferred. The participant took a position with her/his eyes open, the foot of the untested leg resting on the back of the ankle of the tested leg, her arms crossed over her chest, and the balance center in the middle of the platform most comfortably. The analysis protocol was applied at 5 level, consisting of 20 seconds, 1 sample and 3 test repetitions, with a 10-second rest between repetitions. General stability index (OSI), anterior/posterior stability index (APSI), medial/lateral stability index (MLSI) were recorded. The unit of data obtained in this device is the balance index. And values close to 0 indicate high stability. |
day 1
|
|
Balance Performance Measurement(MLSI-noninjured/Better Side-Dual Task)
Time Frame: day 1
|
For balance measurement, Athlete Single Leg Stability, one of the test modes in the Biodex Balance System SD balance device, was preferred. The participant took a position with her/his eyes open, the foot of the untested leg resting on the back of the ankle of the tested leg, her arms crossed over her chest, and the balance center in the middle of the platform most comfortably. The analysis protocol was applied at 5 level, consisting of 20 seconds, 1 sample and 3 test repetitions, with a 10-second rest between repetitions. General stability index (OSI), anterior/posterior stability index (APSI), medial/lateral stability index (MLSI) were recorded. The unit of data obtained in this device is the balance index. And values close to 0 indicate high stability. |
day 1
|
|
Functional Hop Test(THD-injured/Worse Side-Dual Task)
Time Frame: day 1
|
Triple hop for distance ,Crossover hop for distance-CHD -In these two tests, the distance between the starting line and the heel line in step 3 was measured.
Normalization was done by dividing this distance (m) by the athlete's height (m).
|
day 1
|
|
Functional Hop Test (CHD-injured/Worse Side-Dual Task)
Time Frame: day 1
|
Triple hop for distance ,Crossover hop for distance-CHD -In these two tests, the distance between the starting line and the heel line in step 3 was measured.
Normalization was done by dividing this distance (m) by the athlete's height (m).
|
day 1
|
|
Functional Hop Test (6MHT-injured/Worse Side-Dual Task)
Time Frame: day 1
|
6m hop for timed-6MTH: The participant was asked to jump on one leg as fast as possible from the marked start point to the finish point, which is 6 meters away from the marked start point.
The time from the start to the end of 6 meters was recorded.
|
day 1
|
|
Functional Hop Test(THD-noninjured/Better Side-Dual Task)
Time Frame: day 1
|
Triple hop for distance ,Crossover hop for distance-CHD -In these two tests, the distance between the starting line and the heel line in step 3 was measured.
Normalization was done by dividing this distance (m) by the athlete's height (m).
|
day 1
|
|
Functional Hop Test(CHD-noninjured/Better Side-Dual Task)
Time Frame: day 1
|
Triple hop for distance ,Crossover hop for distance-CHD -In these two tests, the distance between the starting line and the heel line in step 3 was measured.
Normalization was done by dividing this distance (m) by the athlete's height (m).
|
day 1
|
|
Functional Hop Test(6MHT-noninjured/Better Side-Dual Task)
Time Frame: day 1
|
day 1
|
|
|
Functional Hop Test THD LSI-Dual Task
Time Frame: day 1
|
The limb symmetry index (LSI) was calculated to evaluate the difference between the two legs in all functional tests.
Calculation for the case group; LSI = Affected leg score ÷ Unaffected leg score × 100 This calculation for the control group; LSI= Worse score ÷ Better score × 100.
|
day 1
|
|
Functional Hop Test CHD LSI-Dual Task
Time Frame: day 1
|
The limb symmetry index (LSI) was calculated to evaluate the difference between the two legs in all functional tests.
Calculation for the case group; LSI = Affected leg score ÷ Unaffected leg score × 100 This calculation for the control group; LSI= Worse score ÷ Better score × 100.
|
day 1
|
|
Functional Hop Test 6MHT LSI-Dual Task
Time Frame: day 1
|
The limb symmetry index (LSI) was calculated to evaluate the difference between the two legs in all functional tests.
Calculation for the case group; LSI = Affected leg score ÷ Unaffected leg score × 100 This calculation for the control group; LSI= Worse score ÷ Better score × 100.
|
day 1
|
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IU-ELIF-001
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
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