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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06459102
Other study ID # KaratayUH12
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date February 1, 2025

Study information

Verified date June 2024
Source KTO Karatay University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study was to determine the effect of motor learning training in addition to a 6-week conventional physiotherapy program on motor imagery, function pain and grip strength in individuals with chronic lateral epicondylitis. At the end of the study, it is aimed to develop a system for motor learning training in individuals with chronic lateral epicondylitis and to create a new exercise protocol.


Description:

The study will include 46 volunteers aged 18-65 years. Participants will be randomly assigned to the Motor learning (n=23) and control (n=23) groups according to an internet-based randomization program. The system to be used in the first phase of the study will be developed. The system will consist of a glove with a pressure sensor on the inner surface and an M-IMU sensor on the outer surface, a computer and a monitor. The pressure sensor on the inner surface will collect instantaneous data on grip force and the M-IMU sensor on the outer surface will collect instantaneous data on wrist movement. The software to be developed will process the instantaneous information from the sensors and reflect it to the monitor. In the second phase of the study, the effectiveness of the motor learning exercise protocol to be applied with the developed system will be evaluated. The motor learning group will receive 3 sessions of motor learning exercise per week for 6 weeks, 5 days a week, in addition to the conventional physiotherapy program. The control group will receive eccentric training for the extensor carpi radialis brevis (ECRB) muscle and static stretching exercises for the ECRB muscle in addition to the conventional physiotherapy program 5 days a week for 6 weeks. All evaluations of the participants will be performed blindly by an independent investigator before and at the end of the study. Participants' motor imagery will be assessed through a left/right judgment task in which they must recognize whether hand images correspond to their left or right side using the Recognise™ application (Neuro Orthopaedic Institute, Adelaide, Australia). Participants' function will be assessed using the Patient Rated Tennis Elbow Evaluation (PRTEE), pain will be assessed using a visual analog scale, and grip strength will be assessed using a hydraulic hand dynamometer. Activities of Daily Living The DASH questionnaire is a questionnaire that asks about physical activities and symptoms of disease. It helps to assess problematic arm, shoulder and hand activities. It is a 30-item questionnaire that assesses the patient's ability to perform certain upper limb activities. These activities include activities performed at home, whether there are complaints such as pain, weakness, tingling in the hand, arm or shoulder, sports activities, etc. The DASH is a self-report questionnaire in which patients can rate difficulties and interventions in their daily lives on a 5-point Likert scale. The lower the calculated DASH score, the better the patient's functionality. Satisfaction Participants' satisfaction will be assessed through a satisfaction survey on technological rehabilitation practices.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 46
Est. completion date February 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - a diagnosis of chronic LET by a physician and - a pain score > 3 on the visual analog scale (VAS) Exclusion Criteria: - concomitant disorders of the wrist and forearm, such as elbow fracture or dislocation, and - treatment with corticosteroid injections within the previous 6 months

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Motor Learning
Konvansiyonel fizyoterapi programina ek olarak 4 hafta, haftada …. Seans motor ögrenme egzersizi yapilacaktir. Egzersiz için katilimci sirt destekli bir sandalyede, bir masanin önünde, kollari masanin üzerinde olacak sekilde oturacaktir. Katilimcinin eline üst yüzeyinde IMU sensor, avuç içerisinde basinç sensörü olan bir eldiven giydirilecek, avuç içine bir silindir yerlestirilecektir. Katilimcidan elindeki silindiri maksimum güçle kavrarken el bilegini ekstansiyona getirmesi ve sonrasinda tekrar fleksiyona getirmesi istenecektir. Katilimciya tüm hareket sirasinda maksimum kuvvetini korumasi istenecektir. Katilimciya hareket boyunca karsisinda yer alan monitörde, kas gücü ve el bileginin eklem hareket açikligi hakkinda görsel geri bildirim saglanacaktir. Katilimcinin avuç içindeki silindirin boyutu ayni tutularak agirligi degistirilerek ayni protokol uygulanacaktir.
Control
The control group will receive a conventional physiotherapy program for 4 weeks, 5 days a week. Eccentric training for the extensor carpi radialis brevis (ECRB) muscle, the most affected wrist extensor tendon, and static stretching exercises for the ECRB muscle will be given. For eccentric training, the weight that the patients can lift in 10 maximal repetitions will be calculated and they will be asked to work with this weight. The best stretching position for the ECRB tendon is extension of the elbow joint, pronation of the forearm and flexion of the wrist with ulnar deviation. Each participant will be taught to perform each exercise for 10 repetitions and 10 seconds. Patients will perform these exercises in a sitting position. In the control group, daily exercises will be performed under the supervision of a physiotherapist

Locations

Country Name City State
Turkey KTO Karatay University Konya Karatay

Sponsors (1)

Lead Sponsor Collaborator
KTO Karatay University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Motor imagery Motor imagery will be assessed through a left/right judgment task in which participants will need to recognize whether hand images correspond to their left or right side using the Recognise™ application (Neuro Orthopaedic Institute, Adelaide, Australia). Baseline, 6 weeks
Secondary Function Total scores range from 0 to 100, with higher scores indicating increased pain and loss of function Baseline, 6 weeks
Secondary Elbow Pain Participants' pain will be assessed with a 10 cm visual analog scale. For pain, 0 (baseline) means no pain and the other end (10, endpoint) means very severe pain; the patient marks his/her pain level on this 10 cm line. The assessment will be done at night, at rest and patient activity pain. Baseline, 6 weeks
Secondary Grip strength The maximal grip strength of the patients will be measured with a hydraulic hand dynamometer. Measurements will be performed in two positions. In the sitting position, measurements will be made in shoulder adduction, elbow 90 flexion, forearm neutral position, wrist 0-30 extension and 0-15 ulnar deviation. In standing position, shoulder abduction, elbow extension and forearm neutral position will be measured. Patients will be asked to press the dynamometer with maximum force for 3 seconds and this value will be recorded as the maximum grip force. The measurements will be repeated three times at 30-second intervals on the affected limb and the average of the measurements will be recorded. Baseline, 6 weeks
Secondary Activities of Daily Living The DASH questionnaire is a questionnaire that asks about physical activities and symptoms of disease. It helps to assess problematic arm, shoulder and hand activities. It is a 30-item questionnaire that assesses the patient's ability to perform certain upper limb activities. These activities include activities performed at home, whether there are complaints such as pain, weakness, tingling in the hand, arm or shoulder, sports activities, etc. The DASH is a self-report questionnaire in which patients can rate difficulties and interventions in their daily lives on a 5-point Likert scale. The lower the calculated DASH score, the better the patient's functionality. Baseline, 6 weeks
Secondary Treatment satisfaction Participants' satisfaction will be assessed through a satisfaction survey on technological rehabilitation practices Baseline, 6 weeks
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