NCT05484778

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 28, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

August 13, 2025

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

Same day

First QC Date

July 4, 2022

Results QC Date

October 2, 2022

Last Update Submit

August 8, 2025

Conditions

Keywords

dual-task paradigm

Outcome Measures

Primary Outcomes (15)

  • Balance Performance Measurement (OSI-injured/Worse Side-Single Task)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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

    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

    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

    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 Outcomes (15)

  • Balance Performance Measurement (OSI-injured/Worse Side-Dual Task)

    day 1

  • Balance Performance Measurement (APSI-injured/Worse Side-Dual Task)

    day 1

  • Balance Performance Measurement (MLSI-injured/Worse Side-Dual Task)

    day 1

  • Balance Performance Measurement (OSI-noninjured/Better Side- Dual Task)

    day 1

  • Balance Performance Measurement(APSI-noninjured/Better Side-Dual Task)

    day 1

  • +10 more secondary outcomes

Study Arms (2)

Case Group

OTHER

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.

Procedure: Dual tasking paradigm

Control Group

OTHER

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.

Procedure: Dual tasking paradigm

Interventions

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.

Case GroupControl Group

Eligibility Criteria

Age14 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Istanbul, Fatih, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Athletic InjuriesKnee InjuriesAnkle InjuriesHip InjuriesReinjuries

Condition Hierarchy (Ancestors)

Wounds and InjuriesLeg Injuries

Results Point of Contact

Title
Aysen Elif YILMAZ
Organization
IstanbulU

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 4, 2022

First Posted

August 2, 2022

Study Start

September 28, 2022

Primary Completion

September 28, 2022

Study Completion

September 30, 2022

Last Updated

August 13, 2025

Results First Posted

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations