Investigating the Effectiveness of Graded Motor Imagery Training in Children With Obstetric Brachial Plexus Injury

NCT06966544 | Recruiting DMC

• 1 other identifier: BakircayU-FTR-HM-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effect of graded motor imagery training on upper extremity motor function, proprioception, functional mobility, balance and quality of life in patients with obstetric brachial plexus injury in addition to conventional treatment. In this context, our aim is to identify new and potential physiotherapeutic approaches to address deficits in motor planning that have been shown to occur at the level of the central nervous system.

Conditions

Obstetric Brachial Plexus Injury

Outcome Measures

Primary Outcomes (4)

• The Modified Mallet Classification System

  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

  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)

  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

  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 Outcomes (6)

• Box and Block Test

  8 Weeks

• Proprioception Assessment

  8 Weeks

• Timed Up and Go Test

  8 Weeks

• Timed Stair Climb Test

  8 Weeks

• Functional Reach Test

  8 Weeks

Study Arms (2)

Conventional Physiotherapy Group

ACTIVE COMPARATOR

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.

Other: Conventional Physiotherapy

Graded Motor Imagery Group

EXPERIMENTAL

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.

Other: Graded Motor Imagery

Interventions

Conventional Physiotherapy OTHER

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

Conventional Physiotherapy Group

Graded Motor Imagery OTHER

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; * Laterality training with the help of visuals selected in the first stage (0-2 weeks) * In the second stage, motor imagery activities designed in the form of scenarios to be developed specifically for motor activity deficiencies seen in OBPY (2-5 weeks) * In the third stage, a mirror therapy program will be prepared (5-8 weeks).

Graded Motor Imagery Group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

Izmir Bakircay University Physiotherapy and Rehabilitation Application and Research Center

Izmir, Menemen, 35400, Turkey (Türkiye)

RECRUITING

Study Officials

• Gulbin Ergin, Associate Professor

  İzmir Bakırcay University

  STUDY DIRECTOR

Central Study Contacts

Hüseyin MAHİROĞLU, Msc

CONTACT

+905327011772; huseyin.mahiroglu@tinaztepe.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Model Details: Two groups; conventional physiotherapy versus conventional physiotherapy plus graded motor imagery training.

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: May 12, 2025
• Study Start: March 4, 2024
• Primary Completion: June 20, 2025
• Study Completion: July 20, 2025
• Last Updated: May 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)