NCT06594497

Brief Summary

Volunteer participants who have undergone anterior cruciate ligament surgery at Bursa Çekirge State Hospital and meet the inclusion criteria will be included in the study. The study will select a sample group from the universe using the probability sampling method (simple random sampling). Participants will be divided into 2 groups: Conventional Physiotherapy + Kinesthetic motor imagery training group and Conventional physiotherapy group with randomization software (https://www.randomizer.org/). Conventional physiotherapy practices created by the physician will be applied by physiotherapists working in the hospital. Knee functions will be evaluated with the IKDC scale, reaction time will be assessed with video recording supported by the Kinovea program, kinesiophobia will be assessed with the Tampa kinesiophobia scale, and finally, autonomic functions will be evaluated with the polar device. Measurements will be repeated after 6 weeks of interventions.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress93%
Sep 2024Aug 2026

First Submitted

Initial submission to the registry

July 31, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

September 27, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

March 5, 2025

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

July 31, 2024

Last Update Submit

March 4, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Kinesiophobia

    Tampa Kinesiophobia Scale: This scale, consisting of 17 questions, evaluates the person's avoidance of movement or fear of re-injury. A Likert-type scale consisting of 4 points is used. 1 point means 'I disagree', and 4 points means 'I agree'. The individual receives a total score between 17 and 68 on this scale. A high score means high kinesiophobia.

    Through study completion, an average of 1 year

  • Activity Level

    Tegner Activity Scale: Although the scale consists of 11 questions in total, the difficulty level increases as you go from 0 to 10. While 0 means that he is either resting or retired due to his knee problem, 10 means that he is at a level where he can play competitive football at the national and elite levels. The individual is asked to mark the most appropriate one among these 11 items according to his activity level.

    Through study completion, an average of 1 year

Secondary Outcomes (2)

  • Knee Fuctions

    Through study completion, an average of 1 year

  • Self-confidence Level

    Through study completion, an average of 1 year

Study Arms (2)

Conventional Physiotherapy group

ACTIVE COMPARATOR

In line with the relevant physician's protocol, Quadriceps Isometric Exercises, Passive ROM exercises, active hip exercises while wearing a brace, ankle exercises, and ice application training are given. The patient is asked to continue as a home program for 2 weeks. After 2 weeks, electrical stimulation (15-20 minutes), current exercises, and ice application continue in the unit. (15min). A total of 30 sessions are applied. In addition, it is requested that the exercises be done at home, as in the treatment program (3x10).

Other: Conventional Physiotherapy

Conventional Physiotherapy + Kinesthetic motor imagery training group

EXPERIMENTAL

Motor imagery training will be planned according to the PETTLEP model. A quiet environment will be provided to minimize distractions during the motor imagery session, and the patient's eyes will be closed throughout the session. At the very beginning of the session, a relaxation exercise lasting approximately 2 minutes will be performed to maximize attention during motor imagery. In relaxation exercises, patients will be asked to focus on their breathing, become aware of each body area, and relax the muscles in these areas. Care will be taken to ensure that the imagined movement is of similar duration to the real and optimal movement. Motor imagery will mostly be studied from a first-person perspective. During kinesthetic imagery, people will be asked to feel the movement of their body parts during each exercise without any body movement occurring. 3 sessions per week will last for 6 weeks in total.

Other: Conventional PhysiotherapyOther: Conventional Physiotherapy + Kinesthetic motor imagery training

Interventions

Conventional Physiotherapy

Conventional Physiotherapy + Kinesthetic motor imagery training groupConventional Physiotherapy group

Conventional Physiotherapy + Kinesthetic motor imagery training

Conventional Physiotherapy + Kinesthetic motor imagery training group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals with anterior cruciate ligament repair,
  • Individuals who have no experience in this type of training,
  • Not having any vision, hearing, or speech problems that would prevent the tests from being performed.
  • Individuals who agree to the purposes of this study and to participate voluntarily.

You may not qualify if:

  • Have previous experience in Motor Imagery techniques or training,
  • Having any orthopedic problem that prevents walking,
  • Having a history of neurological disease,
  • People being treated with any medication that affects the central nervous system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, 43100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Meltem Işıntaş

    Kutahya Health Sciences University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2024

First Posted

September 19, 2024

Study Start

September 27, 2024

Primary Completion

April 1, 2025

Study Completion (Estimated)

August 1, 2026

Last Updated

March 5, 2025

Record last verified: 2024-07

Locations