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

ConditionsBrachial Plexus Birth PalsyPhysical Therapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-14
SponsorIstanbul Aydın University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional Physiotherapy Program

    Other intervention

    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 intervention

    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 intervention

    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.

Treatment groups

14 Participants
are divided into 2 treatment groups
Group A: Dual Task GroupExperimental treatment 2 interventions
Group B: Virtual reality (VR) GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From baseline (pre-treatment) to 12 weeks of intervention and 9-month follow-up after baseline.
2

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.

Time frame
From baseline (pre-treatment) to 12 weeks of intervention and 9 months follow-up after baseline.
3

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.

Time frame
From baseline (pre-treatment) to 12 weeks of intervention and 9 months follow-up after baseline.
4

Muscle Strength

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

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

Secondary outcomes

1

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

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

Time frame
From baseline (pre-treatment) to 12 weeks of intervention and 9 months follow-up after baseline.
2

Modified Mallet Classification

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istanbul Aydın University

Lead sponsor

Istanbul University

Collaborator

Biruni University

Collaborator

Source ClinicalTrials.gov

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