Virtual Reality and Dual-Task Training for Cortical Plasticity in Children With Brachial Plexus Injury

NCT ID: NCT07291310

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2029-01-01

Brief Summary

Brachial plexus birth injury (BPBI) is a condition that occurs when the nerves controlling the arm are injured during birth, leading to weakness, limited movement, and sensory problems. These motor difficulties may also affect cognitive processes related to movement. BPBI requires long-term follow-up and rehabilitation.

This study will compare two treatment approaches in children with BPBI:

• virtual reality (VR)-based exercises, and
• motor-cognitive dual-task exercises. We will examine their effects on brain adaptation (cortical activation), muscle strength, joint motion, proprioception, and upper-limb function. Fourteen children aged 7-14 years will be randomly assigned to one of the two programs, each delivered for 12 weeks. Afterward, participants will continue a 9-month home program. Assessments will be conducted at baseline, after treatment, and at 12 months, including functional MRI (fMRI).

This study will be the first to evaluate long-term brain changes and functional outcomes after these two rehabilitation approaches in children with BPBI.

Detailed Description

Brachial plexus birth injury (BPBI) is characterized by unilateral or bilateral upper extremity motor and sensory impairment resulting from injury to the cervical (C4-C5 to T1-T2) nerve roots and their associated structures during birth. BPBI often leads to limited active movement, muscle weakness, impaired proprioception, and secondary musculoskeletal problems. Beyond these peripheral symptoms, decreased use of the affected limb and chronic motor impairment may influence cognitive processes related to motor planning and execution. Recent literature also highlights the role of central nervous system plasticity in functional recovery; however, evidence remains limited, and long-term cortical adaptation patterns in children with BPBI are not well understood.

This randomized controlled study aims to compare the effects of two rehabilitation approaches-virtual reality (VR)-based exercises and motor-cognitive dual-task exercises-on cortical adaptation, joint range of motion, muscle strength, proprioception, and upper extremity function in children with BPBI. A secondary aim is to examine the relationship between cortical activation and functional performance.

A total of 14 children aged 7-14 years with C5-C6 or C5-C7 involvement, who have not undergone neurosurgery and score ≥26 on the Modified Pediatric Mini Mental Scale, will be included. Participants will be randomly allocated into two groups:

1. VR-based exercise + conventional physiotherapy (n = 7),

2. Dual-task motor-cognitive exercise + conventional physiotherapy (n = 7).

Interventions will be delivered for 12 weeks, three sessions per week, with each session lasting 1 hour. After the supervised intervention period, participants will continue with a structured home program for 9 months. Evaluations will be conducted at baseline, post-intervention (12 weeks), and at 12 months. Cortical activation will be assessed using functional magnetic resonance imaging (fMRI). Additional outcome measures will include joint range of motion, muscle strength, proprioception, Modified Mallet Classification, and the Brachial Plexus Outcome Measure.

This study is designed to provide novel insights into neuroplastic changes associated with two different rehabilitation approaches and to clarify long-term associations between cortical activation and functional recovery. The findings are expected to contribute to the development of multidisciplinary, neuromodulatory rehabilitation strategies aimed at improving upper extremity function and overall quality of life in children with BPBI.

Conditions

Brachial Plexus Birth Palsy; Physical Therapy

Keywords

Brachial Plexus; Physiotherapy; Cortical Plasticity; Virtual Reality; Dual Task

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dual Task Group

Participants in the dual-task group will receive a motor-cognitive dual-task exercise program in addition to conventional physiotherapy. The program includes simultaneous motor activities (such as reaching, grasping, and upper-limb functional tasks) combined with cognitive challenges involving attention, memory, problem-solving, and decision-making. Each session lasts 60 minutes and is delivered three times per week for 12 weeks. The aim of the intervention is to enhance cortical activation, improve motor planning, and support upper-limb functional performance through combined motor and cognitive stimulation.

Group Type: EXPERIMENTAL

Conventional Physiotherapy Program

Intervention Type: OTHER

The conventional physiotherapy program includes educating the child and family about the condition and treatment goals, maintaining regular communication, planning sessions according to the child's abilities, motivating the child, and promoting active participation. Exercises are designed based on functional, daily-life, and play activities to maintain attention and engagement, following El-Shamy et al. (2017).

Before each session, a 15-minute warm-up of shoulder internal rotation, pectoral, and elbow extension stretches will be performed (3 sets of 10 repetitions, 5-second hold).

Dual Task

Intervention Type: OTHER

Children in the dual-task group will perform exercises integrating conventional physiotherapy with cognitive-motor dual-task activities for a total of 45 minutes per session, following Wollesen et al. (2022). Cognitive tasks will be age- and ability-appropriate: younger children will perform basic memory and attention tasks, while older children will engage in more complex problem-solving, rapid decision-making, and language-based tasks.

Task selection will consider the impact on motor performance, including movement quality, divided attention, reaction time, coordination, and executive functions, aiming to maximize motor-cognitive interaction. To maintain motivation, tasks will be gamified, competitive, offer choices based on personal interest, provide feedback, and reward achievements. Task difficulty will be adjusted individually.

Virtual reality (VR) Group

Participants in the virtual reality (VR) group will receive a VR-based exercise program in addition to conventional physiotherapy. The VR program includes interactive upper-limb activities designed to promote active movement, motor control, and engagement through immersive, game-based tasks. Exercises target reaching, grasping, coordination, and proprioceptive awareness in a visually enriched environment. Each session lasts 60 minutes and is conducted three times per week for 12 weeks. The intervention aims to stimulate cortical activation, support motor learning, and enhance upper-limb functional performance.

Group Type: EXPERIMENTAL

Conventional Physiotherapy Program

Intervention Type: OTHER

The conventional physiotherapy program includes educating the child and family about the condition and treatment goals, maintaining regular communication, planning sessions according to the child's abilities, motivating the child, and promoting active participation. Exercises are designed based on functional, daily-life, and play activities to maintain attention and engagement, following El-Shamy et al. (2017).

Before each session, a 15-minute warm-up of shoulder internal rotation, pectoral, and elbow extension stretches will be performed (3 sets of 10 repetitions, 5-second hold).

Virtual Reality

Intervention Type: OTHER

Children in the VR group will perform conventional physiotherapy followed by 20 minutes of VR-based exercises using the Becure Leap Motion system. The games involve interactive tasks designed to improve wrist, hand, and upper-limb movements, coordination, and motor control, with progressively increasing difficulty levels. Sessions are supervised by the study physiotherapist.

Interventions

Conventional Physiotherapy Program

The conventional physiotherapy program includes educating the child and family about the condition and treatment goals, maintaining regular communication, planning sessions according to the child's abilities, motivating the child, and promoting active participation. Exercises are designed based on functional, daily-life, and play activities to maintain attention and engagement, following El-Shamy et al. (2017).

Before each session, a 15-minute warm-up of shoulder internal rotation, pectoral, and elbow extension stretches will be performed (3 sets of 10 repetitions, 5-second hold).

Intervention Type: OTHER

Virtual Reality

Children in the VR group will perform conventional physiotherapy followed by 20 minutes of VR-based exercises using the Becure Leap Motion system. The games involve interactive tasks designed to improve wrist, hand, and upper-limb movements, coordination, and motor control, with progressively increasing difficulty levels. Sessions are supervised by the study physiotherapist.

Intervention Type: OTHER

Dual Task

Children in the dual-task group will perform exercises integrating conventional physiotherapy with cognitive-motor dual-task activities for a total of 45 minutes per session, following Wollesen et al. (2022). Cognitive tasks will be age- and ability-appropriate: younger children will perform basic memory and attention tasks, while older children will engage in more complex problem-solving, rapid decision-making, and language-based tasks.

Task selection will consider the impact on motor performance, including movement quality, divided attention, reaction time, coordination, and executive functions, aiming to maximize motor-cognitive interaction. To maintain motivation, tasks will be gamified, competitive, offer choices based on personal interest, provide feedback, and reward achievements. Task difficulty will be adjusted individually.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Children aged 7-14 years
• Diagnosed with unilateral DBPP
• C5-C6 or C5-C7 involvement (Narakas I, IIa, IIb)
• Modified Pediatric Mini-Mental Scale score ≥26
• Child and parent willing to participate in the study

Exclusion Criteria

• Previous nerve surgery for DBPP
• Surgery within the past year or Botulinum Toxin injection within the past 3 months
• Any neurological condition other than DBPP
• Vision or hearing impairments affecting participation
• Contraindications for fMRI
• Fixed contractures in shoulder, elbow, wrist, or finger joints
• Participation in regular physiotherapy or other rehabilitation programs within the past 3 months

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: collaborator

Biruni University

OTHER

Sponsor Role: collaborator

Istanbul Aydın University

OTHER

Sponsor Role: lead

Responsible Party

Barış CELBEK

Lecturer in Physiotherapy and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeynep Hoşbay

Role: PRINCIPAL_INVESTIGATOR

Biruni University

Central Contacts

Barış CELBEK, Ph.D.

Role: CONTACT

Phone: 05077536669

Email: bariscelbek3@gmail.com

CELBEK

Role: CONTACT

Phone: 05077536669

Email: bariscelbek3@gmail.com

Other Identifiers

225S038

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024-BİAEK/14-49

Identifier Type: -

Identifier Source: org_study_id