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NCT Number: NCT07291310

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

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.

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Key information

Conditions

Brachial Plexus Birth Palsy Physical Therapy

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional Physiotherapy Program

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

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.

Dual Task

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.

Primary outcomes

  1. Change in Motor Cortex Activation (BOLD Signal) Measured by fMRI

    Time frame: From baseline (pre-treatment) to 12 weeks of intervention and 9-month follow-up after baseline.

    Motor cortex activation will be evaluated before treatment, after 12 weeks, and at 9-month follow-up using non-contrast BOLD fMRI during finger and elbow movements to assess cortical plasticity.

  2. Range of Motion (ROM)

    Time frame: From baseline (pre-treatment) to 12 weeks of intervention and 9 months follow-up after baseline.

    Active joint movement of the affected upper limb will be measured with an electronic goniometer in standardized positions for shoulder, elbow, and wrist.

  3. Brachial Plexus Outcome Measure (BPOM)

    Time frame: From baseline (pre-treatment) to 12 weeks of intervention and 9 months follow-up after baseline.

    Functional performance of the upper limb in daily activities will be assessed using a validated scale, including shoulder, elbow, and hand tasks. The BPOM consists of three domains (shoulder, elbow, and hand) and includes 11 task-based activities, each scored on a 5-point scale (1-5). The total BPOM score ranges from 11 to 55, with higher scores indicating better upper limb functional performance.

  4. Muscle Strength

    Time frame: From baseline (pre-treatment) to 12 weeks of intervention and 9 months follow-up after baseline.

    Upper limb muscle groups will be tested using a handheld dynamometer with standardized positions and the "make method."

Secondary outcomes

  1. Change in Joint Position Sense Error (Degrees) of the Upper Limb Measured

    Time frame: From baseline (pre-treatment) to 12 weeks of intervention and 9 months follow-up after baseline.

    Joint position sense for shoulder, elbow, and wrist will be evaluated using a KForce Sens® device, comparing target and replicated angles with eyes closed.

  2. Modified Mallet Classification

    Time frame: From baseline (pre-treatment) to 12 weeks of intervention and 9 months follow-up after baseline

    Global upper limb movement patterns and functional ability will be assessed using 5 key shoulder and hand tasks, scored 1-5.

Study contacts

Contact information is provided by the study sponsor or research team.

Barış CELBEK, Ph.D.

CONTACT

[email protected]

05077536669

CELBEK

CONTACT

[email protected]

05077536669

Sponsors and collaborators

Lead sponsor

Istanbul Aydın University

Other

Collaborators

  • Biruni University
  • Istanbul University

Registry information

Official study title

Development of Cortical Plasticity Through Virtual Reality and Dual-Task Training in Children With Brachial Plexus Birth Injury: A Different Perspective in Paediatric Neurorehabilitation

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 18, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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