Meniscus LesionNCT06886542
Comparison of the Effectiveness of Single and Dual Task Training Applied to Individuals With Knee Meniscus Lesion
A study testing Dual task training, Single task training and Conventional physiotherapy in people with Meniscus Lesion, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The main function of the meniscus is to transfer and distribute femoral pressure to the tibia. Treatment of meniscus tears is divided into conservative and surgical treatment. The most preferred methods for patients with meniscus lesions include meniscectomy and exercise therapy. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Meniscus Lesion
- What is being tested?
- Dual task training, Single task training and Conventional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jun 2025to 17 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 to 65 years old
- According to magnetic resonance imaging (MRI) results, there is a maximum of Grade 2 degenerative bilateral meniscus tear
- Having a Standardized Mini Mental Test score of 24 and above
- Volunteering
- Know how to read and write
- Not having vision or hearing problems that cannot be corrected with a device
- Being able to walk independently in society
Who cannot join
- Not meeting the inclusion criteria
- Having compliance issues or emotional and cognitive problems that will prevent participation in the assessments and clinical practices to be used in the study
- Having problems participating in exercises or follow-ups
- Having had surgery related to the lower extremity
- Having a neuromuscular disease
- Having a history of systemic inflammatory joint disease
Show all 9Show fewer
- Having a rheumatic disease
- Having an additional pathology in the knee
- Receiving additional treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Recep Tayyip Erdoğan University
Rize, Turkey, 53350
Rumeysa Reis Kul, 05367390930, rumeysa.reis@erdogan.edu.tr
About this study
Official title: Comparison of the Effectiveness of Single and Dual Task Training Applied to Individuals With Knee Meniscus Lesion: A Randomized Controlled, Single-Blind Study
The main function of the meniscus is to transfer and distribute femoral pressure to the tibia. Treatment of meniscus tears is divided into conservative and surgical treatment. The most preferred methods for patients with meniscus lesions include meniscectomy and exercise therapy. The anterior and posterior horns of the meniscus contain numerous mechanoreceptors, including Ruffini endings (slow adapting) and Pacinian corpuscles (fast adapting), which provide information about the position and movement of the joint. Reduced proprioception due to mechanoreceptor damage from meniscus tears may be associated with decreased postural stability, as sensory information associated with a patient's conscious perception of joint movement through mechanoreceptors in the meniscus may contribute to postural stability.
Dual task is based on the simultaneous maintenance of motor-motor or cognitive-motor performance. Dual tasking is used to evaluate the simultaneous performance of a postural task and a motor or cognitive task to examine the interaction or effect of the secondary task on primary task performance. In a purposeful movement, it is necessary to have the ability to adapt to overcome environmental loads and achieve the goal. This also involves performing a cognitive task simultaneously while performing a motor task. In knee meniscus lesions, knee joint position sense and sensory input decrease, walking speed decreases, and attention devoted to walking increases.
Read the detailed description
Complex movement formation needs to be restructured as a result of sensory and motor disorders. With the loss of movement organization, postural control becomes vulnerable to cognitive attention elements and additional motor tasks. While physical disability creates a burden for the individual and society, it also has a negative impact on executive functions. Robust cognitive processes are essential when performing complex motor tasks and ensuring stable walking. Because the dependence on cognitive resources increases to compensate for the loss of control in postural stability and balance. Although walking and balance are considered to be automatic tasks, performance decreases when processing capacity is exceeded by a simultaneous task. In dual task studies, it has been reported that there is an increase in step time and a decrease in step length due to the increase in the single and double support phases of walking. This situation has been interpreted as a strategy developed to maintain balance in dual task conditions. With the dual task training to be applied to these individuals, it is aimed to ensure that motor control, balance, and the complex movements they encounter in daily life activities can be maintained in balance while walking.
- Conditions
- Meniscus Lesion
- Being tested
- Dual task training, Single task training, Conventional physiotherapy
- Keywords
- knee meniscus lesion, dual task training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual task trainingOther
Dual task training is based on the simultaneous maintenance of motor-motor or cognitive-motor performance. The exercises given in single task training will be applied by combining them with cognitive and motor cognitive tasks.
Single task trainingOther
Single task training is a training approach that aims to improve the performance of individuals by focusing on only one task at a time.
Conventional physiotherapyOther
Range of motion, stretching, resistance exercises, isometric exercise, Before the treatment, a Hotpack will be applied to warm up the muscles, increase flexibility and improve performance. After exercise, transcutaneous electrical stimulation (TENS) will be used to relieve pain, reduce muscle tension and provide faster recovery.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients in this group are the group to which dual task training and conventional physiotherapy will be applied Receives: Other: Dual task training; Other: Conventional physiotherapy |
| Control group | Active comparator | Patients in this group are the group to which single task training and conventional physiotherapy will be applied. Receives: Other: Single task training; Other: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Balance
The Modified Four Square Step Test will be used in the dynamic balance assessment.The test involves changing direction while taking steps forward, backward, and sideways. Individuals will be asked to stand in square number 1 and face square number 2. The movement will be started and they will be asked to step into squares number 2,3,4,1,4,3,2,1 in order. First, they will take a turn clockwise and then counterclockwise. Two measurements will be made and the average value will be recorded in seconds. The test will be repeated with single task, cognitive dual task and motor dual task.
Measured: Change from baseline at 8 weeks treatment program and two months after.
Static Balance
Static balance will be assessed with a one-leg standing test.The test starts when one foot leaves the ground and ends when it touches the ground again, in case of excessive oscillation or jumping with the foot on the ground. The person is asked to stand on one leg for as long as possible. The test is terminated when 30 seconds are reached. The test will be applied to bilateral lower extremities with single task, cognitive dual task, and motor dual task.
Measured: Change from baseline at 8 weeks treatment program and two months after.
Gait Evaluation
A 10-meter walking test will be used to evaluate individuals' walking. Two measurements will be made and the average value will be recorded in seconds. The test will be repeated with single task, cognitive dual task and motor dual task.
Measured: Change from baseline at 8 weeks treatment program and two months after.
Assessment of Functional Mobility
The Timed Up and Go Test will be used to assess functional mobility. In this test, the individual is asked to stand up while sitting in a chair with armrests and no wheels with the command 'Start', walk at his/her normal pace on a flat surface to a colored tape that was previously attached 3 meters away, then turn around and walk back to the chair and sit down again. The test will be repeated twice and the average time will be recorded in seconds. The test will be repeated with a single task, a cognitive dual task and a motor dual task.
Measured: Change from baseline at 8 weeks treatment program and two months after.
Joint Position Sense
Joint position sense is evaluated by the angular difference between a repeatedly determined target position and the estimated position, and this is called absolute angular error. 30° and 60° knee flexion will be determined as target angles. A smartphone measurement application will be used for measurement. For the test position, individuals will be seated with their hips and knees at 90° flexion and their feet off the ground, and while the knee is slowly brought from 90° flexion to passive extension, individuals will be asked to perceive and learn this position by first stopping at 60° flexion angle for 5 seconds. Then, the individual will be asked to bring their knee to this target angle and the measurement will be made. The difference will be recorded as absolute angular error. The same process will be done for 30° flexion angle. Three repetitions will be requested for both positions and the averages will be calculated and recorded.
Measured: Change from baseline at 8 weeks treatment program and two months after.
Secondary outcomes (5)
Functional Capacity Assessment
The timed sit-to-stand test is a test used to measure muscular strength and endurance. The individual is asked to sit down and stand up as many times as possible in 30 seconds without support from a 43-45 cm high chair without armrests, with their feet shoulder-width apart, and the number reached is recorded.
Measured: Change from baseline at 8 weeks treatment program and two months after.
Evaluation of the Functional Level of the Knee
The Western Ontario Meniscal Evaluation Tool (WOMET) will be used in this evaluation. This inventory includes 16 items representing the areas of influence of physical symptoms (nine items), sports/leisure/work/lifestyle (four items) and emotions (three items). A value between "0-10" is requested for each item. The score for each subgroup is obtained by dividing the marked values of the questions belonging to that section by the number of questions and multiplying by 10. The total score is obtained by adding all the scores, dividing by 16 and multiplying by 10.
Measured: Change from baseline at 8 weeks treatment program and two months after.
Dual Task Assessment
The evaluation of dual task performance will be done with the Dual Task Evaluation Questionnaire. The Likert type survey consists of 10 questions. It includes the answers (4) very often, (3) often, (2) sometimes, (1) rarely and not applicable. The total score is calculated as the average value per question.
Measured: Change from baseline at 8 weeks treatment program and two months after.
Pain level
Visual analog scale will be used to examine pain levels of participants. Individuals are presented with a line numbered evenly from 1 to 10 and asked to mark the point corresponding to their pain intensity. A higher score indicates that severity of pain increasing.
Measured: Change from baseline at 8 weeks treatment program and two months after.
Muscle Strength Measurement
In this evaluation, a Lafayette brand digital hand dynamometer will be used. This device objectively shows the amount of force used in the muscle test. The knee extension force will be determined by placing the dynamometer distal to the tibia while the patient is in a sitting position and the knee is flexed at 65 degrees, and the patient will be asked to perform a maximal isometric contraction. The knee flexion force will be determined by placing the dynamometer distal to the tibia while the patient is in a prone position and the knee is flexed at 75 degrees, and the patient will be asked to perform a maximal isometric contraction. The measurement will be repeated 3 times and the highest value will be recorded.
Measured: Change from baseline at 8 weeks treatment program and two months after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start17 Jun 2025 (estimated)
- Primary completion17 Aug 2026 (estimated)
- Study completion17 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus LesionStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment dual parallel group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rumeysa Reis Kul MSc, Principal investigator, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886542
- Sponsor's protocol ID
- 26.12.24/ 10-1059
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Indivudual participant data will be available to the responsible researcher.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Single and Dual Task Training Applied to Individuals With Knee Meniscus Lesion: A Randomized Controlled, Single-Blind Study
- ClinicalTrials.gov ID
- NCT06886542
- Acronym / sponsor ID
- 26.12.24/ 10-1059
- Conditions
- Meniscus Lesion
- Keywords
- knee meniscus lesion, dual task training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 17 Jun 2025 (estimated)
- Primary completion
- 17 Aug 2026 (estimated)
- Study completion
- 17 Aug 2026 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main function of the meniscus is to transfer and distribute femoral pressure to the tibia. Treatment of meniscus tears is divided into conservative and surgical treatment. The most preferred methods for patients with meniscus lesions include meniscectomy and exercise therapy. The anterior and posterior horns of the meniscus contain numerous mechanoreceptors, including Ruffini endings (slow adapting) and Pacinian corpuscles (fast adapting), which provide information about the position and movement of the joint. Reduced proprioception due to mechanoreceptor damage from meniscus tears may be associated with decreased postural stability, as sensory information associated with a patient's conscious perception of joint movement through mechanoreceptors in the meniscus may contribute to postural stability.
Dual task is based on the simultaneous maintenance of motor-motor or cognitive-motor performance. Dual tasking is used to evaluate the simultaneous performance of a postural task and a motor or cognitive task to examine the interaction or effect of the secondary task on primary task performance. In a purposeful movement, it is necessary to have the ability to adapt to overcome environmental loads and achieve the goal. This also involves performing a cognitive task simultaneously while performing a motor task. In knee meniscus lesions, knee joint position sense and sensory input decrease, walking speed decreases, and attention devoted to walking increases.
Detailed description
Complex movement formation needs to be restructured as a result of sensory and motor disorders. With the loss of movement organization, postural control becomes vulnerable to cognitive attention elements and additional motor tasks. While physical disability creates a burden for the individual and society, it also has a negative impact on executive functions. Robust cognitive processes are essential when performing complex motor tasks and ensuring stable walking. Because the dependence on cognitive resources increases to compensate for the loss of control in postural stability and balance. Although walking and balance are considered to be automatic tasks, performance decreases when processing capacity is exceeded by a simultaneous task. In dual task studies, it has been reported that there is an increase in step time and a decrease in step length due to the increase in the single and double support phases of walking. This situation has been interpreted as a strategy developed to maintain balance in dual task conditions. With the dual task training to be applied to these individuals, it is aimed to ensure that motor control, balance, and the complex movements they encounter in daily life activities can be maintained in balance while walking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment dual parallel group design
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Dual task training, Other: Conventional physiotherapyPatients in this group are the group to which dual task training and conventional physiotherapy will be applied |
| Control group | Active comparator | Other: Single task training, Other: Conventional physiotherapyPatients in this group are the group to which single task training and conventional physiotherapy will be applied. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 40 to 65 years old
- According to magnetic resonance imaging (MRI) results, there is a maximum of Grade 2 degenerative bilateral meniscus tear
- Having a Standardized Mini Mental Test score of 24 and above
- Volunteering
- Know how to read and write
Key exclusion criteria (9 listed)
- Not meeting the inclusion criteria
- Having compliance issues or emotional and cognitive problems that will prevent participation in the assessments and clinical practices to be used in the study
- Having problems participating in exercises or follow-ups
- Having had surgery related to the lower extremity
- Having a neuromuscular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual task trainingDual task training is based on the simultaneous maintenance of motor-motor or cognitive-motor performance. The exercises given in single task training will be applied by combining them with cognitive and motor cognitive tasks. | Other | Treatment group |
| Single task trainingSingle task training is a training approach that aims to improve the performance of individuals by focusing on only one task at a time. | Other | Control group |
| Conventional physiotherapyRange of motion, stretching, resistance exercises, isometric exercise, Before the treatment, a Hotpack will be applied to warm up the muscles, increase flexibility and improve performance. After exercise, transcutaneous electrical stimulation (TENS) will be used to relieve pain, reduce muscle tension and provide faster recovery. | Other | Control group, Treatment group |
Primary outcome
Dynamic Balance
Time frame: Change from baseline at 8 weeks treatment program and two months after.
The Modified Four Square Step Test will be used in the dynamic balance assessment.The test involves changing direction while taking steps forward, backward, and sideways. Individuals will be asked to stand in square number 1 and face square number 2. The movement will be started and they will be asked to step into squares number 2,3,4,1,4,3,2,1 in order. First, they will take a turn clockwise and then counterclockwise. Two measurements will be made and the average value will be recorded in seconds. The test will be repeated with single task, cognitive dual task and motor dual task.
Static Balance
Time frame: Change from baseline at 8 weeks treatment program and two months after.
Static balance will be assessed with a one-leg standing test.The test starts when one foot leaves the ground and ends when it touches the ground again, in case of excessive oscillation or jumping with the foot on the ground. The person is asked to stand on one leg for as long as possible. The test is terminated when 30 seconds are reached. The test will be applied to bilateral lower extremities with single task, cognitive dual task, and motor dual task.
Gait Evaluation
Time frame: Change from baseline at 8 weeks treatment program and two months after.
A 10-meter walking test will be used to evaluate individuals' walking. Two measurements will be made and the average value will be recorded in seconds. The test will be repeated with single task, cognitive dual task and motor dual task.
Assessment of Functional Mobility
Time frame: Change from baseline at 8 weeks treatment program and two months after.
The Timed Up and Go Test will be used to assess functional mobility. In this test, the individual is asked to stand up while sitting in a chair with armrests and no wheels with the command 'Start', walk at his/her normal pace on a flat surface to a colored tape that was previously attached 3 meters away, then turn around and walk back to the chair and sit down again. The test will be repeated twice and the average time will be recorded in seconds. The test will be repeated with a single task, a cognitive dual task and a motor dual task.
Joint Position Sense
Time frame: Change from baseline at 8 weeks treatment program and two months after.
Joint position sense is evaluated by the angular difference between a repeatedly determined target position and the estimated position, and this is called absolute angular error. 30° and 60° knee flexion will be determined as target angles. A smartphone measurement application will be used for measurement. For the test position, individuals will be seated with their hips and knees at 90° flexion and their feet off the ground, and while the knee is slowly brought from 90° flexion to passive extension, individuals will be asked to perceive and learn this position by first stopping at 60° flexion angle for 5 seconds. Then, the individual will be asked to bring their knee to this target angle and the measurement will be made. The difference will be recorded as absolute angular error. The same process will be done for 30° flexion angle. Three repetitions will be requested for both positions and the averages will be calculated and recorded.
5 secondary outcomes
Functional Capacity Assessment
Time frame: Change from baseline at 8 weeks treatment program and two months after.
Evaluation of the Functional Level of the Knee
Time frame: Change from baseline at 8 weeks treatment program and two months after.
Dual Task Assessment
Time frame: Change from baseline at 8 weeks treatment program and two months after.
Pain level
Time frame: Change from baseline at 8 weeks treatment program and two months after.
Muscle Strength Measurement
Time frame: Change from baseline at 8 weeks treatment program and two months after.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: No. Indivudual participant data will be available to the responsible researcher.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rumeysa Reis Kul MSc principal investigator
Recep Tayyip Erdogan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual task training, Single task training and Conventional physiotherapy in people with Meniscus Lesion, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rumeysa Reis Kul MSc (05367390930, rumeysa.reis@erdogan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Balance (time frame: Change from baseline at 8 weeks treatment program and two months after.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.