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

NCT07291310 | Not Yet Recruiting

• 2 other identifiers: 2024-BİAEK/14-49225S038
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Brachial Plexus Birth Palsy; Physical Therapy

Keywords

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

Outcome Measures

Primary Outcomes (4)

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

  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.

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

• Range of Motion (ROM)

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

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

• Brachial Plexus Outcome Measure (BPOM)

  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.

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

• Muscle Strength

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

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

Secondary Outcomes (2)

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

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

• Modified Mallet Classification

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

Study Arms (2)

Dual Task Group

EXPERIMENTAL

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.

Other: Conventional Physiotherapy Program; Other: Dual Task

Virtual reality (VR) Group

EXPERIMENTAL

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.

Other: Conventional Physiotherapy Program; Other: Virtual Reality

Interventions

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).

Dual Task Group; Virtual reality (VR) Group

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.

Virtual reality (VR) Group

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.

Dual Task Group

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biruni University: collaborator
• Istanbul Aydın University: lead
• Istanbul University: collaborator

Study Officials

• Zeynep Hoşbay

  Biruni University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barış CELBEK, Ph.D.

CONTACT

05077536669; bariscelbek3@gmail.com

CELBEK

CONTACT

05077536669; bariscelbek3@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Physiotherapy and Rehabilitation

Model Details: This study uses a parallel assignment design in which participants are randomly allocated to one of two intervention groups: a virtual reality-based exercise program or a dual-task motor-cognitive exercise program, both in addition to conventional physiotherapy

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share