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

Official 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

Overview

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.

Interventions

• Other 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, an
• 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.
• 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 performa

Primary outcome measures

• 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.]
• Range of Motion (ROM) [Time frame: From baseline (pre-treatment) to 12 weeks of intervention and 9 months follow-up after baseline.]
• Brachial Plexus Outcome Measure (BPOM) [Time frame: From baseline (pre-treatment) to 12 weeks of intervention and 9 months follow-up after baseline.]
• Muscle Strength [Time frame: From baseline (pre-treatment) to 12 weeks of intervention and 9 months follow-up after baseline.]

Secondary outcome measures (2)

• 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.]
• Modified Mallet Classification [Time frame: From baseline (pre-treatment) to 12 weeks of intervention and 9 months follow-up after baseline]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Biruni University — Istanbul

Identifiers

NCT: NCT07291310 · 2024-BİAEK/14-49 · 225S038

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗