Brachial Plexus Birth PalsyNCT07291310
Virtual Reality and Dual-Task Training for Cortical Plasticity in Children With Brachial Plexus Injury
A study testing Conventional Physiotherapy Program, Virtual Reality and Dual Task in people with Brachial Plexus Birth Palsy and Physical Therapy, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Brachial Plexus Birth Palsy, Physical Therapy
- What is being tested?
- Conventional Physiotherapy Program, Virtual Reality and Dual Task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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:
Read more
- 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.
Read the 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:
- 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.
- Conditions
- Brachial Plexus Birth Palsy, Physical Therapy
- Being tested
- Conventional Physiotherapy Program, Virtual Reality, Dual Task
- Keywords
- Brachial Plexus, Physiotherapy, Cortical Plasticity, Virtual Reality, Dual Task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Physiotherapy ProgramOther
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 RealityOther
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 TaskOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Physiotherapy Program; Other: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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
Joint position sense for shoulder, elbow, and wrist will be evaluated using a KForce Sens® device, comparing target and replicated angles with eyes closed.
Measured: From baseline (pre-treatment) to 12 weeks of intervention and 9 months follow-up after baseline.
Modified Mallet Classification
Global upper limb movement patterns and functional ability will be assessed using 5 key shoulder and hand tasks, scored 1-5.
Measured: From baseline (pre-treatment) to 12 weeks of intervention and 9 months follow-up after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Apr 2026
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brachial Plexus Birth PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University, Biruni University
- Responsible party
- Principal investigator, Barış CELBEK, Istanbul Aydın University
- Investigators
- Zeynep Hoşbay, Principal investigator, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291310
- Sponsor's protocol ID
- 2024-BİAEK/14-49
- Other IDs
- 225S038
- Status last verified
- Aug 2026
- First submitted
- 5 Dec 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07291310
- Acronym / sponsor ID
- 2024-BİAEK/14-49
- Conditions
- Brachial Plexus Birth Palsy, Physical Therapy
- Keywords
- Brachial Plexus, Physiotherapy, Cortical Plasticity, Virtual Reality, Dual Task
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Collaborators
- Istanbul University, Biruni University
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Dual Task Group | Experimental | Other: Conventional Physiotherapy Program, Other: Dual TaskParticipants 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. |
| Virtual reality (VR) Group | Experimental | Other: Conventional Physiotherapy Program, Other: Virtual RealityParticipants 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. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Physiotherapy ProgramThe 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). | Other | Dual Task Group, Virtual reality (VR) Group |
| Virtual RealityChildren 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 | Virtual reality (VR) Group |
| Dual TaskChildren 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. | Other | Dual Task Group |
Primary outcome
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.
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.
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.
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."
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zeynep Hoşbay principal investigator
Biruni University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physiotherapy Program, Virtual Reality and Dual Task in people with Brachial Plexus Birth Palsy and Physical Therapy, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.