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

NCT06966544 | Completed DMC

• 1 other identifier: BakircayU-FTR-HM-01
• Study Type: interventional
• Target: 42
• 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; Birth Related Brachial Plexus Injury; Neonatal Brachial Plexus Palsy

Outcome Measures

Primary Outcomes (3)

• Change from Baseline in the Modified Mallet Total Score at 8 Weeks

  The Modified Mallet Classification is a valid and reliable scale frequently used in the literature to determine the functional status of the upper extremity in individuals with brachial plexus injuries. Rather than assessing the functions of individual muscles, this classification system evaluates the global functional characteristics of the affected upper extremity. It assesses five movements: global abduction, global external rotation, hand-to-neck, hand-to-mouth, and hand-to-spine. Each movement is scored from 1 to 5 according to the position achieved and the quality of movement. The total score ranges from 5 to 25, with higher scores indicating better upper extremity function.

  Baseline and 8 weeks

• Change from Baseline in Active Movement Scale Scores at 8 Weeks

  The Active Movement Scale was developed by the Brachial Plexus Clinic at The Hospital for Sick Children in Toronto. In children with obstetric brachial plexus injury, the affected upper extremity is evaluated across 15 joint movements extending from the shoulder to the fingers. Each movement is initially assessed with gravity eliminated. If full movement is achieved in the gravity-eliminated position, the movement is subsequently evaluated against gravity. Each movement is scored separately from 0 to 7, with higher scores indicating better active movement performance.

  Baseline and 8 weeks

• Change from Baseline in Range of Motion at 8 Weeks

  Range of motion (ROM) was assessed using a universal goniometer to identify movement limitations in the upper-extremity joints. Measurements were performed according to standard goniometric measurement principles and recorded in degrees. Active range of motion of the shoulder, elbow, forearm, and wrist joints of the affected upper extremity was evaluated. The assessed movements included shoulder flexion, extension, abduction, internal rotation, and external rotation; elbow flexion and extension; forearm supination and pronation; and wrist flexion and extension. During the assessment, the participants' starting positions and the placement of the goniometer axis, stationary arm, and moving arm were standardized according to established measurement procedures. Care was taken to prevent compensatory movements originating from the trunk, scapula, shoulder, and forearm.

  Baseline and 8 weeks

Secondary Outcomes (14)

• Change from Baseline in Movement Imagery Questionnaire for Children Scores at 8 Weeks

  Baseline and 8 weeks

• Change from Baseline in Kinesthetic and Visual Imagery Questionnaire-20 Scores at 8 Weeks

  Baseline and 8 weeks

• Change from Baseline in Raimondi Hand Score at 8 Weeks

  Baseline and 8 weeks

• Change from Baseline in Gilbert-Raimondi Score for Elbow Function at 8 Weeks

  Baseline and 8 weeks

• Change from Baseline in Gilbert Shoulder Scale Scores at 8 Weeks

  Baseline and 8 weeks

Study Arms (2)

Conventional Physiotherapy Group

ACTIVE COMPARATOR

Participants in the control group received a standardized conventional physiotherapy program for 45 minutes, twice weekly for 8 weeks. The program included upper extremity range of motion exercises, selective strengthening, stretching, sensory-motor stimulation, functional activities, trunk stabilization, balance exercises and a home exercise program.

Other: Conventional Physiotherapy

Graded Motor Imagery Group

EXPERIMENTAL

Participants in the study group received a graded motor imagery program in addition to the same conventional physiotherapy program. The graded motor imagery program was applied for 15 minutes per session, twice weekly for 8 weeks, and included lateralization training, explicit motor imagery training and mirror therapy.

Other: Graded Motor Imagery

Interventions

Graded Motor Imagery OTHER

The graded motor imagery program was applied in addition to conventional physiotherapy for 15 minutes per session, twice weekly for 8 weeks. The program consisted of three sequential phases. During weeks 0-2, lateralization training was performed using Recognise™ Hand and Recognise™ Shoulder applications. During weeks 2-6, explicit motor imagery training was applied according to PETTLEP principles, progressing from simple upper extremity movements to individualized functional and participation-based activities. During weeks 6-8, mirror therapy was performed, progressing from distal hand and wrist movements to proximal, reaching and functional upper extremity tasks. Participants were instructed to focus on the visual or imagined movement without actual movement during imagery tasks and to perceive the mirror reflection as movement of the affected extremity during mirror therapy.

Graded Motor Imagery Group

Conventional Physiotherapy OTHER

The conventional physiotherapy program was delivered for 45 minutes per session, twice weekly for 8 weeks. The program was individualized according to the child's age, functional level, cooperation, severity and type of involvement. It included passive, active-assisted and active range of motion exercises for the shoulder, elbow, forearm, wrist and fingers; selective strengthening exercises for scapulothoracic and upper extremity muscles; stretching of shortened muscles and soft tissues using static manual and PNF techniques when indicated; age-appropriate functional upper extremity activities such as reaching, grasping, releasing, carrying, bimanual tasks and activities of daily living; sensory-motor stimulation activities; trunk mobility and stabilization exercises; static and dynamic balance exercises; and a home exercise program.

Conventional Physiotherapy 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
• Having a Modified Mini-Mental State Examination score of \<27.

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

Izmir Bakircay University Physiotherapy and Rehabilitation Application and Research Center

Izmir, Menemen, 35400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neonatal Brachial Plexus Palsy

Condition Hierarchy (Ancestors)

Brachial Plexus Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Birth Injuries; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Wounds and Injuries

Study Officials

• Gulbin Ergin, Professor

  Izmir Bakircay University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor was blinded to group allocation. Participants, care providers, and investigators were not masked due to the nature of the physiotherapy interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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: November 11, 2023
• Primary Completion: June 20, 2026
• Study Completion: June 20, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)