- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06459102
The Effect of Motor Learning Exercises on Lateral Epicondylitis
The Effect of Motor Learning Exercises on Motor Imagery, Function, Pain and Grip Strength in Individuals With Chronic Lateral Epicondylitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Karatay
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Konya, Karatay, Turkey
- KTO Karatay University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Motor Learning
In addition to the conventional physiotherapy program, motor learning exercise will be performed for 6 weeks, 3 sessions per week.
For the exercise, the participant will sit in a chair with back support, in front of a table, with arms on the table.
The participant will wear a glove with an IMU sensor on the upper surface and a pressure sensor on the palm, and a cylinder will be placed in the palm.
The participant will be asked to bring the wrist into extension and then back into flexion while grasping the cylinder with maximum force.
The participant will be asked to maintain maximum strength during the entire movement.
The participant will be given visual feedback on muscle strength and range of motion of the wrist on the monitor in front of them throughout the movement.
The same protocol will be applied by keeping the size of the cylinder in the participant's palm the same and changing the weight.
|
In addition to the conventional physiotherapy program .... per week for 4 weeks Sessions of motor learning exercise will be performed.
For the exercise, the participant will sit in a chair with back support, in front of a table, with arms on the table.
The participant will wear a glove with an IMU sensor on the upper surface and a pressure sensor on the palm, and a cylinder will be placed in the palm.
The participant will be asked to bring the wrist into extension and then back into flexion while grasping the cylinder with maximum force.
The participant will be asked to maintain maximum strength during the entire movement.
The participant will be given visual feedback on muscle strength and range of motion of the wrist on the monitor in front of them throughout the movement.
The same protocol will be applied by keeping the size of the cylinder in the participant's palm the same and changing the weight.
|
|
Active Comparator: 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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motor imagery
Time Frame: Baseline, 6 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Function
Time Frame: Baseline, 6 weeks
|
Total scores range from 0 to 100, with higher scores indicating increased pain and loss of function
|
Baseline, 6 weeks
|
|
Elbow Pain
Time Frame: Baseline, 6 weeks
|
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
|
|
Grip strength
Time Frame: Baseline, 6 weeks
|
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
|
|
Activities of Daily Living
Time Frame: Baseline, 6 weeks
|
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
|
|
Treatment satisfaction
Time Frame: Baseline, 6 weeks
|
Participants' satisfaction will be assessed through a satisfaction survey on technological rehabilitation practices
|
Baseline, 6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KaratayUH12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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