- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06966544
- Original Trial
Investigating the Effectiveness of Graded Motor Imagery Training in Children With Obstetric Brachial Plexus Injury
Investigating the Effectiveness of Graded Motor Imagery Training on Upper Limb Function, Proprioception, Functional Mobility, Balance and Quality of Life in Children With Obstetric Brachial Plexus Injury
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hüseyin MAHİROĞLU, Msc
- Phone Number: +905327011772
- Email: huseyin.mahiroglu@tinaztepe.edu.tr
Study Locations
-
-
Menemen
-
Izmir, Menemen, Turkey, 35400
- Recruiting
- Izmir Bakircay University Physiotherapy and Rehabilitation Application and Research Center
-
Contact:
- Hüseyin MAHİROĞLU, MSc.
- Phone Number: +905327011772
- Email: huseyin.mahiroglu@tinaztepe.edu.tr
-
Contact:
-
Principal Investigator:
- Hüseyin MAHİROĞLU, MSc.
-
Sub-Investigator:
- Gülbin Ergin, Associate Professor
-
Sub-Investigator:
- Hande Gazeteci Tekin, Associate Professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Obtaining family consent and the child's willingness
- Being between the ages of 7-18
- Being diagnosed with obstetric brachial plexus injury
- Not having received physical therapy in the last 6 months
Exclusion Criteria:
- Having a traumatic (postnatal) brachial plexus injury
- Having undergone surgery for complications related to brachial plexus injury within the last six months (release, tendon transfer, osteotomy, etc.)
- Having another neurological, neuromuscular, musculoskeletal or cardiopulmonary system disease in addition to OBPI
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 |
|---|---|
|
Active Comparator: Conventional Physiotherapy Group
Participants were randomly divided into two arms.
Participants in the activate comparator group will be administered traditional physiotherapy approaches applied after obstetric brachial plexus injury by the researcher physiotherapist.
|
All subjects to be included in our study were evaluated before and after treatment by a physiotherapist acting as a blinded evaluator. In the treatment, conventional physiotherapy approaches are applied twice a week for 8 weeks by the physiotherapist conducting the thesis study. In parallel with the initial evaluation, an individualized conventional physiotherapy program is created according to the functional status of the children and the severity and type of the affected area. The main topics of this program consist of the following: Normal range of motion exercises for shoulder, elbow, wrist and fingers, strengthening exercises for scapulothoracic, shoulder, elbow, hand-wrist joints in all directions, stretching exercises for shoulder, elbow, wrist, fingers (to be selected depending on the patient's involvement), scapulothoracic mobilization, glenohumeral mobilization and elbow according to possible limitations, hand-wrist joint mobilization techniques (myofascial release, gliding |
|
Experimental: Graded Motor Imagery Group
Participants included in the motor imagery group through randomization will receive a progressive motor imagery approach in addition to the conventional physiotherapy treatment received by the first group.
All applications are performed by the same physiotherapist.
|
All approaches applied to the conventional physiotherapy group are applied to this group in the same manner and duration (8 weeks-twice a week). However, in addition to conventional physiotherapy, progressive motor imagery (AMI) training program is being applied twice a week for 8 weeks. In the GMI program, in addition to this program, components of GMI training will be applied to sequentially activate cortical motor networks and improve cortical organization. These are;
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Modified Mallet Classification System
Time Frame: 8 weeks
|
The modified Mallet classification is one of the valid and reliable scales frequently used in the literature to determine the functional status of the extremity in cases with brachial plexus lesions.
This classification system aims to evaluate the global characteristics of the extremity rather than evaluating the functions of individual muscles.
In this system, the extremity's global abduction, global external rotation, and the adequacy of the hand reaching the neck, mouth and back to the spine are evaluated.
A score between 0 and 5 is made according to the position and degree of strain during each movement.
The maximum score that can be obtained is 25, and the score obtained gives an idea about the functional status of the extremity.
|
8 weeks
|
|
Active Movement Scale
Time Frame: 8 weeks
|
Prepared by the Brachial Plexus Clinic of The Hospital for Sick Children (Toronto).
In the OBPY group, the affected upper extremity was evaluated with 15 joint movements (from the shoulder to the fingers) specified on the scale.
The movement is first examined in the position where gravity is eliminated, and if a full score is obtained, it is evaluated in the position against gravity and a score between (0-7) is given.
|
8 weeks
|
|
The Quality of Upper Extremity Skills Test (QUEST)
Time Frame: 8 Weeks
|
QUEST is a test that evaluates the child's manual skills and the quality of movement.
It was developed by Prof. Dr. Carol De MATTEO for use in the 18-month-8 age group.
Later, the validity and reliability study of this test was conducted for 4-12 age groups.
There are studies in the literature regarding its use in children between the ages of 2-15.
The sections of QUEST are as follows: A. Independent movements B. Grasping C. Weight bearing D. Protective extension E. Hand function rate F. Cooperation rates.
|
8 Weeks
|
|
Range of Motion Measurement
Time Frame: 8 Weeks
|
Range of motion will be assessed by measuring the range of motion of the shoulder, elbow and wrist joints with a universal goniometer.
Active joint movements of the patients will be measured with a universal goniometer before and after treatment and recorded as degrees.
|
8 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Box and Block Test
Time Frame: 8 Weeks
|
The Box and Block Test is a test developed to measure gross manual dexterity.
It is a good indicator of the severity of upper extremity involvement in OBPY.
In the study, the number of blocks collected in 60 seconds is calculated as in the original procedure of the test.
|
8 Weeks
|
|
Proprioception Assessment
Time Frame: 8 Weeks
|
For proprioceptive sense evaluation, joint position sense evaluation (angle reconstruction test) is used in shoulder and elbow joints.
The joint to be measured is ensured to be seen clearly.
Digital inclinometer is used to evaluate poprioceptive sense.
Shoulder joint proprioceptive sense is performed three times at 60, 90 and 120 degree angles using active reposition test.
Eyes are covered with a tape.
It is brought from 0 degree starting position to target angles of and waited for 5 seconds for the individual to learn this position and placed back to the starting position.
The individual is then asked to actively bring his arm to the previously taught target angle and this test is repeated 3 times for each target angle.
After the test, the average of the three angles is taken for each target angle.
Elbow joint flexion is evaluated as specified at 30, 60, 90° angles.
|
8 Weeks
|
|
Timed Up and Go Test
Time Frame: 8 Weeks
|
The Timed Up and Go Test is a simple, practical and rapid test used to assess functional mobility and dynamic balance.
Children are asked to get up from a standard chair with back and arm support, walk a predetermined distance of 3 meters as fast as possible without running, return without touching anything, walk back to the chair and return to a sitting position.
The time taken is recorded in seconds (sec).
|
8 Weeks
|
|
Timed Stair Climb Test
Time Frame: 8 Weeks
|
The Timed Stair Climbing and Descending Test is another test that has been proven to be valid and reliable in the assessment of functional mobility and dynamic balance.
The test begins with the child standing 30 cm away from the bottom rung of a 10-step staircase and climbing the steps with the command.
The individual is asked to climb the steps safely but as quickly as possible and then turn and descend without waiting after climbing the last step, and the test is completed when the individual descends the last step with both feet touching the ground.
The test score is recorded as time (sec).
|
8 Weeks
|
|
Functional Reach Test
Time Frame: 8 Weeks
|
This test was developed to assess stability.
The functional reach test is an easily applicable, performance-based assessment method.
It is defined as the maximum distance that an individual can reach forward in the horizontal plane while maintaining stability on the support surface in a standing position.
The person holds the shoulder parallel to the surface being measured while in 90-degree flexion.
The distance between the shoulder and the tip of the 3rd finger is measured.
Then, patients are asked to reach the farthest distance possible without moving their feet, and the point where the tip of the 3rd finger reaches is marked on the surface.
|
8 Weeks
|
|
Quality of Life Assesment
Time Frame: 8 Weeks
|
The pediatric quality of life scale (PedsQL 4.0) will be used to assess health-related quality of life.
The scale was developed to assess the health-related quality of life of children and adolescents aged 2-18 and consists of 5 main headings.
These are; physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning.
|
8 Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gulbin Ergin, Associate Professor, Izmir Bakırçay University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- BakircayU-FTR-HM-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Obstetric Brachial Plexus Injury
-
Biruni UniversityRecruitingBrachial Plexus Palsy | Brachial Plexus Birth Palsy | Brachial Plexus Palsy Due to Birth Trauma | Obstetric Brachial Plexus InjuryTurkey (Türkiye)
-
Istanbul University - CerrahpasaCompletedObstetric Brachial Plexus InjuryTurkey (Türkiye)
-
Emine AtıcıCompletedObstetric Brachial Plexus InjuryTurkey
-
Siriraj HospitalCompletedBrachial Plexus Injury | Brachial Plexus PalsyThailand
-
All India Institute of Medical Sciences, New DelhiCompletedBrachial Plexus InjuryIndia
-
Hacettepe UniversityRecruitingObstetric Brachial Plexus InjuryTurkey
-
Istanbul University - Cerrahpasa (IUC)CompletedBrachial Plexus Palsy | Obstetric; InjuryTurkey
-
Huashan HospitalCompleted
-
University of British ColumbiaChildren's & Women's Health Centre of British ColumbiaWithdrawnBirth Related Brachial Plexus Injury | Obstetrical Brachial Plexus Palsy
-
Centre Hospitalier Universitaire VaudoisWithdrawnBrachial Plexus InjurySwitzerland
Clinical Trials on Conventional Physiotherapy
-
Istanbul Demiroglu Bilim UniversityCompletedMuscle Weakness | Rehabilitation | Intensive Care Unit SyndromeTurkey
-
University of SalamancaCompleted
-
Pamukkale UniversityCompletedChronic Low-back PainTurkey
-
Kirsehir Ahi Evran UniversitesiEnrolling by invitation
-
International Hellenic UniversityRecruiting
-
Kutahya Health Sciences UniversityRecruitingAnterior Cruciate Ligament InjuriesTurkey
-
Bezmialem Vakif UniversityCompleted
-
Riphah International UniversityRecruitingLateral EpicondylitisPakistan
-
University of LahoreRecruitingHypotonic Cerebral PalsyPakistan
-
Eastern Mediterranean UniversityCompletedCervical SpondylosisCyprus