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Studiando l'efficacia dell'addestramento delle immagini motorie classificate nei bambini con lesioni ostetriche del plesso brachiale

27 settembre 2026 aggiornato da: Hüseyin MAHİROĞLU, Izmir Bakircay University

Studiando l'efficacia dell'addestramento delle immagini motorie classificate sulla funzione degli arti superiori, sulla propriocezione, sulla mobilità funzionale, sull'equilibrio e sulla qualità della vita nei bambini con lesioni ostetriche del plesso brachiale

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study was planned as a randomized, controlled, single-blind study. The aim of this study was to investigate the effects of graded motor imagery (GMI) training, performed in addition to conventional treatment of patients with obstetric brachial plexus injury, on upper extremity motor function, proprioception, functional mobility and quality of life. In parallel to the initial assessment, a conventional physiotherapy program was created that is individualized according to the functional status and severity of the effects in the children. In the GMI program, in addition to this program, the components of GMI training are applied to sequentially activate the cortical motor networks and develop cortical organization. All assessments of the participants before and at the end of the treatment are carried out by a blind physiotherapist.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

42

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Menemen
      • Izmir, Menemen, Turchia (Türkiye), 35400
        • Izmir Bakircay University Physiotherapy and Rehabilitation Application and Research Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 7 anni a 18 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Conventional Physiotherapy Group

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.

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.

Sperimentale: Graded Motor Imagery Group

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.

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in the Modified Mallet Total Score at 8 Weeks
Lasso di tempo: Baseline and 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
Lasso di tempo: Baseline and 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
Lasso di tempo: Baseline and 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in Movement Imagery Questionnaire for Children Scores at 8 Weeks
Lasso di tempo: Baseline and 8 weeks

The Movement Imagery Questionnaire for Children was used to assess the child's motor imagery ability. The questionnaire evaluates the ability to mentally imagine movements using three imagery modalities: internal visual imagery, external visual imagery and kinesthetic imagery. The child is asked to imagine specific movements and then rate how easy or difficult the imagery experience was. Each item is scored on a 7-point scale, where lower scores indicate more difficult imagery and higher scores indicate easier and better imagery ability. Subscale scores are calculated for internal visual imagery, external visual imagery and kinesthetic imagery. Higher subscale and total scores indicate better motor imagery ability.

Baseline and 8 weeks
Change from Baseline in Kinesthetic and Visual Imagery Questionnaire-20 Scores at 8 Weeks
Lasso di tempo: Baseline and 8 weeks

The Kinesthetic and Visual Imagery Questionnaire-20 was used to evaluate visual and kinesthetic motor imagery ability. Participants are asked to perform or assume specific movement positions and then mentally imagine the same movement. For each item, the clarity of the visual image and the intensity of the kinesthetic sensation are rated separately. Visual imagery is scored according to how clear the imagined image is, and kinesthetic imagery is scored according to how strongly the movement sensation is felt. Each item is scored on a 5-point scale. Higher visual imagery scores indicate clearer mental images, and higher kinesthetic imagery scores indicate stronger kinesthetic sensations. Higher total scores indicate better motor imagery ability.

Baseline and 8 weeks
Change from Baseline in Raimondi Hand Score at 8 Weeks
Lasso di tempo: Baseline and 8 weeks

Raimondi Hand Score was used to evaluate hand function of the affected upper extremity. The classification assesses functional hand use, including grasp ability, finger flexion and extension, wrist movement, thumb use and forearm rotation. The score ranges from 0 to 5. A score of 0 indicates complete paralysis or absence of grasp, while higher scores indicate progressively better hand and finger function. A score of 5 represents strong finger flexion and extension, full pronation and supination, and good use of the thumb and intrinsic hand muscles. Higher scores indicate better hand function.

Baseline and 8 weeks
Change from Baseline in Gilbert-Raimondi Score for Elbow Function at 8 Weeks
Lasso di tempo: Baseline and 8 weeks

Gilbert-Raimondi Elbow Function Scale was used to assess elbow movements. The scale comprises three components: the degree of active elbow flexion achieved, elbow extension strength, and extension deficit. During the assessment, elbow flexion and extension movements were explained to the participant, who was then instructed to perform them actively. The elbow extension deficit was also measured in degrees. Flexion was scored as 1 when there was no movement or only muscle contraction, 2 for incomplete movement, and 3 for complete movement. Extension was scored as 0 when no movement was present, 1 when extension was weak, and 2 when it was good. The extension deficit was scored as 0 for 0-30°, -1 for 30-50°, and -2 for deficits greater than 50°. Based on the total score, elbow function was classified as poor for scores of 0-1, moderate for scores of 2-3, and good for scores of 4-5. Higher scores indicate better elbow function.

Baseline and 8 weeks
Change from Baseline in Gilbert Shoulder Scale Scores at 8 Weeks
Lasso di tempo: Baseline and 8 weeks

Gilbert Shoulder Function Rating System was used to assess shoulder function and the degree of recovery of shoulder movements in participants with obstetric brachial plexus injury (OBPI). This system grades shoulder function based on shoulder abduction and active external rotation. During the assessment, participants were instructed to actively perform shoulder abduction and external rotation. Scores ranged from 0 to 5 based on the degree of shoulder abduction and active external rotation, with higher scores indicating better shoulder function.

Baseline and 8 weeks
Change from Baseline in Quality of Upper Extremity Skills Test Scores at 8 Weeks
Lasso di tempo: Baseline and 8 weeks

The Quality of Upper Extremity Skills Test (QUEST) is a performance-based assessment tool developed to evaluate the quality of upper-extremity movement and manual skills in children. During the assessment, participants were observed in accordance with the standardized test instructions. Dissociated and controlled movement skills were assessed in the dissociated movements domain; the ability to grasp and release objects in the grasp domain; the capacity to bear weight through the upper extremity in the weight-bearing domain; and protective upper-extremity responses to loss of balance or postural changes in the protective extension domain. Scoring was performed according to the formulas and standardized instructions provided in the scoring manual. Each domain score and the overall QUEST score range from 0 to 100, with higher scores indicating better quality of upper-extremity movement and functional ability.

Baseline and 8 weeks
Change from Baseline in Box and Block Test Score at 8 Weeks
Lasso di tempo: Baseline and 8 weeks

The Box and Block Test was used to assess gross manual dexterity and functional hand performance. The test was administered using a standard box divided into two compartments by a partition and equally sized wooden blocks. During the assessment, the participant was seated at a table, and the box was positioned so that the compartment containing the blocks was on the side of the extremity being tested. Before the test, the instructions were explained to the participant, and a brief practice trial was provided to ensure comprehension. The participant was then instructed to transfer the blocks one at a time from one compartment to the other as quickly as possible for 60 seconds. At the end of the test, the number of blocks transferred to the opposite compartment was recorded. A higher score indicated better gross manual dexterity and functional performance of the upper extremity.

Baseline and 8 weeks
Change from Baseline in Hand Grip Strength at 8 Weeks
Lasso di tempo: Baseline and 8 weeks

Handgrip strength was assessed using a Jamar hydraulic hand dynamometer. Measurements were performed in the standard testing position recommended by the American Society of Hand Therapists. Participants were seated with their hips and knees flexed to approximately 90°, the shoulder adducted, the forearm in a neutral position, the elbow flexed to 90°, and the wrist positioned at 0-30° of extension. Participants were instructed to grip the dynamometer and squeeze with their maximum possible force and were verbally encouraged during each measurement. Three measurements were performed for the affected upper extremity, with brief rest intervals between trials. The mean of the three measurements was calculated and recorded in kilograms. Higher values indicate greater handgrip strength.

Baseline and 8 weeks
Change from Baseline in T-Shirt Donning and Doffing Test Completion Time at 8 Weeks
Lasso di tempo: Baseline and 8 weeks

The T-Shirt Donning and Doffing Test was administered to assess upper-extremity functional performance and movement ability during activities of daily living. The test was performed using a standard T-shirt, with the participant standing 30 cm behind a table. Upon receiving the command, the participant was instructed to put on the T-shirt, take it off, and place it back on the table. The test ended when the removed T-shirt touched the table, and the elapsed time was recorded in seconds. The test was repeated three times, and the mean of the three trials was used in the analysis. A shorter completion time indicates better upper-extremity functional performance.

Baseline and 8 weeks
Change from Baseline in Proprioception at 8 Weeks
Lasso di tempo: Baseline and 8 weeks

Proprioceptive accuracy was assessed at the shoulder and elbow using an active joint position reproduction test with a digital inclinometer. During testing, the participant's vision was occluded. For shoulder abduction, the examiner passively moved the affected arm from the 0° starting position to the target angles of 60° and 90°. Each target position was maintained for 5 seconds to allow the participant to perceive and learn the position, after which the arm was returned to the starting position. The participant was then asked to actively reproduce the target angle. The same procedure was performed for elbow flexion at target angles of 60°, and 90°. Three trials were completed at each target angle. The absolute angular error between the target angle and the actively reproduced angle was calculated for each trial, and the mean of the three trials was recorded in degrees.

Baseline and 8 weeks
Change from Baseline in Timed Up and Go Test Completion Time at 8 Weeks
Lasso di tempo: Baseline and 8 weeks

The Timed Up and Go Test is a simple, practical, and rapid performance-based test used to assess functional mobility and dynamic balance. The child is instructed to stand up from a standard chair with a backrest and armrests, walk a predetermined distance of 3 meters as quickly and safely as possible without running, turn around without touching or receiving support from any object, walk back to the chair, and return to a seated position. The time required to complete the test is recorded in seconds. Lower completion times indicate better functional mobility and dynamic balance.

Baseline and 8 weeks
Change from Baseline in Timed Up and Down Stairs Test Completion Time at 8 Weeks
Lasso di tempo: Baseline and 8 weeks

The Timed Up and Down Stairs Test is a valid and reliable performance-based test used to assess functional mobility and dynamic balance. The test begins with the child standing 30 cm from the bottom of a 10-step staircase. On command, the child is instructed to ascend the stairs as quickly and safely as possible, turn around immediately after reaching the top step without pausing, and descend the stairs. Timing begins with the command to start and ends when the child steps off the lowest step and places both feet on the floor. The time required to complete the test is recorded in seconds. Lower completion times indicate better functional mobility and dynamic balance.

Baseline and 8 weeks
Change from Baseline in Functional Reach Test Distance at 8 Weeks
Lasso di tempo: Baseline and 8 weeks

The Functional Reach Test is an easily administered, performance-based assessment used to evaluate dynamic balance and postural stability. It measures the maximum distance an individual can reach forward in the horizontal plane while maintaining a fixed base of support in standing. The participant stands beside, but does not touch, the measurement surface and raises the arm to 90° of shoulder flexion. The initial position of the tip of the third finger is recorded. The participant is then instructed to reach forward as far as possible without moving the feet, taking a step, touching the measurement surface, or losing balance. The final position of the tip of the third finger is recorded. The functional reach distance is calculated as the difference between the initial and final positions and is reported in centimeters. Greater distances indicate better dynamic balance and postural stability.

Baseline and 8 weeks
Change from Baseline in Quality of Life Scores at 8 Weeks
Lasso di tempo: Baseline and 8 weeks

PedsQL 4.0 was used to assess the participants' health-related quality of life. The scale consists of 23 items and evaluates four core domains: physical functioning, emotional functioning, social functioning, and school functioning. Subscale scores are calculated by averaging the corresponding item scores, whereas the total scale score is calculated by averaging all item scores. Items are rated on a 5-point Likert scale and reverse-scored and linearly transformed to a 0-100 scale. Higher scores indicate better health-related quality of life.

Baseline and 8 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Direttore dello studio: Gulbin Ergin, Professor, Izmir Bakircay University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

11 novembre 2023

Completamento primario (Effettivo)

20 giugno 2026

Completamento dello studio (Effettivo)

20 giugno 2026

Date di iscrizione allo studio

Primo inviato

4 maggio 2025

Primo inviato che soddisfa i criteri di controllo qualità

4 maggio 2025

Primo Inserito (Effettivo)

12 maggio 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • BakircayU-FTR-HM-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared because the dataset includes pediatric clinical data and will be used for planned long-term follow-up analyses. Data will be kept confidential and accessible only to the research team.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .