NCT06886542

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Jun 2025Aug 2026

First Submitted

Initial submission to the registry

March 7, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

June 17, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2026

Last Updated

May 20, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

March 7, 2025

Last Update Submit

May 15, 2025

Conditions

Keywords

knee meniscus lesiondual task training

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    Change from baseline at 8 weeks treatment program and two months after.

Secondary Outcomes (5)

  • Functional Capacity Assessment

    Change from baseline at 8 weeks treatment program and two months after.

  • Evaluation of the Functional Level of the Knee

    Change from baseline at 8 weeks treatment program and two months after.

  • Dual Task Assessment

    Change from baseline at 8 weeks treatment program and two months after.

  • Pain level

    Change from baseline at 8 weeks treatment program and two months after.

  • Muscle Strength Measurement

    Change from baseline at 8 weeks treatment program and two months after.

Study Arms (2)

Treatment group

EXPERIMENTAL

Patients in this group are the group to which dual task training and conventional physiotherapy will be applied

Other: Dual task trainingOther: Conventional physiotherapy

Control group

ACTIVE COMPARATOR

Patients in this group are the group to which single task training and conventional physiotherapy will be applied.

Other: Single task trainingOther: Conventional physiotherapy

Interventions

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.

Treatment group

Single task training is a training approach that aims to improve the performance of individuals by focusing on only one task at a time.

Control group

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.

Control groupTreatment group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Having a rheumatic disease
  • Having an additional pathology in the knee
  • Receiving additional treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdoğan University

Rize, Turkey, 53350, Turkey (Türkiye)

Location

Study Officials

  • Rumeysa Reis Kul MSc

    Recep Tayyip Erdogan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rumeysa Reis Kul MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The evaluation of the patients will be carried out by a blinded investigator.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment dual parallel group design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2025

First Posted

March 20, 2025

Study Start

June 17, 2025

Primary Completion (Estimated)

August 17, 2026

Study Completion (Estimated)

August 17, 2026

Last Updated

May 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Indivudual participant data will be available to the responsible researcher.

Locations