Obstetric Brachial Plexus InjurySI-BPINCT07134049
Sensory Integration Therapy in Children With Congenital Brachial Plexus Injury: Developmental Outcomes
A study testing sensory integration therapy in people with Obstetric Brachial Plexus Injury, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate the effectiveness of sensory integration therapy in reducing sensory, motor, and cognitive developmental impairments following Congenital Brachial Plexus Injury (CBPI), and to support the overall developmental processes of affected children. Read more about this study
- Who is it for?
- Ages 7 to 35 months
- Conditions the study is for
- Obstetric Brachial Plexus Injury
- What is being tested?
- sensory integration therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jun 2025to 31 Dec 2026
- 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 35 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Confirmed diagnosis of obstetric brachial plexus injury (OBPI) Age between 7 and 35 months No additional diagnosed neurological, psychiatric, and/or muscular disorders No diagnosed mental retardation or cognitive disorder that would prevent participation in assessments Written informed consent from parents or legal guardians
Who cannot join
- Severe visual or hearing impairment preventing participation in assessments Participation in another experimental rehabilitation program within the last 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.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe Univeristy
Ankara
cigdem oksuz, Professor, +90 533 344 22 85
About this study
Official title: Investigation of the Effects of Sensory Integration Therapy on Sensory, Motor, and Cognitive Development in Children With Congenital Brachial Plexus Injury
The purpose of this study is to investigate the effectiveness of sensory integration therapy in reducing sensory, motor, and cognitive developmental impairments following Congenital Brachial Plexus Injury (CBPI), and to support the overall developmental processes of affected children.
Read the detailed description
Detailed Description:
Congenital Brachial Plexus Injury (CBPI) is a peripheral nerve injury occurring during childbirth that can lead to varying degrees of sensory, motor, and functional impairments. These impairments may adversely affect not only motor skills but also sensory processing and cognitive development, particularly in early childhood when neurodevelopment is highly plastic. Sensory integration therapy is a child-centered, play-based intervention designed to improve the brain's ability to process and integrate sensory information from the tactile, vestibular, proprioceptive, visual, and auditory systems. By providing enriched and graded sensory experiences, this therapeutic approach aims to promote adaptive responses, improve motor planning, enhance self-regulation, and support overall developmental progress.
The purpose of this study is to evaluate the effectiveness of sensory integration therapy in reducing sensory, motor, and cognitive developmental impairments in children with CBPI aged 7 to 35 months. Participants in the intervention group will receive individualized sensory integration therapy sessions once a week for 8 weeks, in addition to their routine physiotherapy programs. Developmental outcomes will be assessed using standardized assessment tools before and after the intervention. The findings of this study are expected to contribute to evidence-based rehabilitation approaches for children with CBPI and to inform early intervention strategies aimed at optimizing sensory, motor, and cognitive development.
- Conditions
- Obstetric Brachial Plexus Injury
- Being tested
- sensory integration therapy
- Keywords
- sensory integration, Cognitive development, Motor development, obstetric brachial plexus palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensory integration therapyOther
Sensory Integration Therapy (SIT) is a client-centered rehabilitation approach aimed at improving adaptive and functional responses to sensory stimuli in changing environments. It is based on structured, individualized activities conducted in enriched sensory environments. These environments are designed to be engaging and motivating for children through the use of interactive and playful tasks that match their sensory processing profiles.
Sensory integration plays a key role in motor planning, postural control, attention, and emotional regulation. Deficits in sensory integration-particularly in vestibular, tactile, and proprioceptive systems-may result in poor muscle tone, difficulty with balance and coordination, and impaired motor planning. These issues can negatively impact the development of gross motor, fine motor, language, and academic skills. For this reason, sensory-based interventions that support neural organization and promote adaptive responses are commonly recommended i
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Participants in this group receive individualized sensory integration therapy sessions once a week for 8 weeks, in addition to their routine physiotherapy program. Each session lasts approximately 45 minutes and is based on the core principles of sensory integration therapy. The intervention includes activities involving tactile, vestibular, proprioceptive, auditory, and visual stimuli, tailored to each child's sensory processing needs. Therapy is provided in a sensory-enriched and safe environment, and aims to promote adaptive responses, motor planning, self-regulation, and functional skills. Sessions are play-based and structured to support engagement and motivation. Receives: Other: sensory integration therapy |
| control group | No intervention | Participants in this group will not receive any sensory integration therapy during the 8-week study period. Instead, they will continue with their existing routine physiotherapy program, which may include general motor exercises, range of motion activities, and other standard therapeutic practices. No additional sensory-based interventions will be introduced. This group serves as a comparator to assess the effects of sensory integration therapy provided to the experimental group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) is a standardized assessment tool designed to evaluate the developmental functioning of infants and toddlers aged 1 to 42 months. It measures five key domains: Cognitive, Language (Receptive and Expressive), Motor (Fine and Gross), Social-Emotional, and Adaptive Behavior.
The Bayley-III is widely used in clinical and research settings to identify developmental delays and to monitor developmental progress over time
Measured: The assessment will be conducted at the beginning of the treatment and repeated at the end of the 8-week treatment period.
Secondary outcomes (3)
Dunn Infant/Toddler Sensory Profile (7-35 months)
The Dunn Infant/Toddler Sensory Profile is a standardized caregiver questionnaire designed to assess sensory processing patterns in infants and toddlers aged 7 to 35 months. Developed by Winnie Dunn, the tool evaluates how young children respond to sensory experiences in their daily environments, based on caregiver observations.
Measured: The assessment will be conducted at the beginning of the treatment and repeated at the end of the 8-week treatment period.
Active Movement Scale (AMS)
The Active Movement Scale (AMS) is a standardized clinical assessment tool used to evaluate voluntary motor function in infants and young children, particularly those with brachial plexus birth injury (BPBI) or other upper limb neuromuscular impairments.
The AMS is designed for children from birth up to 1 year of age and beyond, depending on developmental stage. It assesses active range of motion (AROM) in the upper extremities, both against gravity and with gravity eliminated.
Measured: The assessment will be conducted at the beginning of the treatment and repeated at the end of the 8-week treatment period
Modified Mallet Grading System (MMGS)
The Modified Mallet Grading System (MMGS) is a clinical assessment tool used to evaluate shoulder function in patients with brachial plexus birth palsy (BPBP). It measures the functional range and quality of specific shoulder movements through observation of task-based activities.
The MMGS is widely used due to its simplicity, reliability, and ability to track surgical and therapeutic outcomes over time.
Measured: he assessment will be conducted at the beginning of the treatment and repeated at the end of the 8-week treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start23 Jun 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Brachial Plexus InjuryStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Cimilli, Hacettepe University
- Investigators
- Çiğdem Öksüz, PhD, Professor,, Principal investigator, Hacettepe University Faculty of Health Sciences, Department of Occupational Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134049
- Sponsor's protocol ID
- E-68552689-000-00004173157
- Other IDs
- Hacettepe University
- Acronym
- SI-BPI
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Sensory Integration Therapy on Sensory, Motor, and Cognitive Development in Children With Congenital Brachial Plexus Injury
- ClinicalTrials.gov ID
- NCT07134049
- Acronym / sponsor ID
- SI-BPI / E-68552689-000-00004173157
- Conditions
- Obstetric Brachial Plexus Injury
- Keywords
- sensory integration, Cognitive development, Motor development, obstetric brachial plexus palsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Aug 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.
The purpose of this study is to investigate the effectiveness of sensory integration therapy in reducing sensory, motor, and cognitive developmental impairments following Congenital Brachial Plexus Injury (CBPI), and to support the overall developmental processes of affected children.
Detailed description
Detailed Description:
Congenital Brachial Plexus Injury (CBPI) is a peripheral nerve injury occurring during childbirth that can lead to varying degrees of sensory, motor, and functional impairments. These impairments may adversely affect not only motor skills but also sensory processing and cognitive development, particularly in early childhood when neurodevelopment is highly plastic. Sensory integration therapy is a child-centered, play-based intervention designed to improve the brain's ability to process and integrate sensory information from the tactile, vestibular, proprioceptive, visual, and auditory systems. By providing enriched and graded sensory experiences, this therapeutic approach aims to promote adaptive responses, improve motor planning, enhance self-regulation, and support overall developmental progress.
The purpose of this study is to evaluate the effectiveness of sensory integration therapy in reducing sensory, motor, and cognitive developmental impairments in children with CBPI aged 7 to 35 months. Participants in the intervention group will receive individualized sensory integration therapy sessions once a week for 8 weeks, in addition to their routine physiotherapy programs. Developmental outcomes will be assessed using standardized assessment tools before and after the intervention. The findings of this study are expected to contribute to evidence-based rehabilitation approaches for children with CBPI and to inform early intervention strategies aimed at optimizing sensory, motor, and cognitive development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: sensory integration therapyParticipants in this group receive individualized sensory integration therapy sessions once a week for 8 weeks, in addition to their routine physiotherapy program. Each session lasts approximately 45 minutes and is based on the core principles of sensory integration therapy. The intervention includes activities involving tactile, vestibular, proprioceptive, auditory, and visual stimuli, tailored to each child's sensory processing needs. Therapy is provided in a sensory-enriched and safe environment, and aims to promote adaptive responses, motor planning, self-regulation, and functional skills. Sessions are play-based and structured to support engagement and motivation. |
| control group | No intervention | –Participants in this group will not receive any sensory integration therapy during the 8-week study period. Instead, they will continue with their existing routine physiotherapy program, which may include general motor exercises, range of motion activities, and other standard therapeutic practices. No additional sensory-based interventions will be introduced. This group serves as a comparator to assess the effects of sensory integration therapy provided to the experimental group |
Who may qualify
- Ages
- 7 to 35 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Confirmed diagnosis of obstetric brachial plexus injury (OBPI) Age between 7 and 35 months No additional diagnosed neurological, psychiatric, and/or muscular disorders No diagnosed mental retardation or cognitive disorder that would prevent participation in assessments Written informed consent from parents or legal guardians
Key exclusion criteria (1 listed)
- Severe visual or hearing impairment preventing participation in assessments Participation in another experimental rehabilitation program within the last 3 months
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 |
|---|---|---|
| sensory integration therapySensory Integration Therapy (SIT) is a client-centered rehabilitation approach aimed at improving adaptive and functional responses to sensory stimuli in changing environments. It is based on structured, individualized activities conducted in enriched sensory environments. These environments are designed to be engaging and motivating for children through the use of interactive and playful tasks that match their sensory processing profiles. Sensory integration plays a key role in motor planning, postural control, attention, and emotional regulation. Deficits in sensory integration-particularly in vestibular, tactile, and proprioceptive systems-may result in poor muscle tone, difficulty with balance and coordination, and impaired motor planning. These issues can negatively impact the development of gross motor, fine motor, language, and academic skills. For this reason, sensory-based interventions that support neural organization and promote adaptive responses are commonly recommended i | Other | intervention group |
Primary outcome
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
Time frame: The assessment will be conducted at the beginning of the treatment and repeated at the end of the 8-week treatment period.
The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) is a standardized assessment tool designed to evaluate the developmental functioning of infants and toddlers aged 1 to 42 months. It measures five key domains: Cognitive, Language (Receptive and Expressive), Motor (Fine and Gross), Social-Emotional, and Adaptive Behavior. The Bayley-III is widely used in clinical and research settings to identify developmental delays and to monitor developmental progress over time
3 secondary outcomes
Dunn Infant/Toddler Sensory Profile (7-35 months)
Time frame: The assessment will be conducted at the beginning of the treatment and repeated at the end of the 8-week treatment period.
Active Movement Scale (AMS)
Time frame: The assessment will be conducted at the beginning of the treatment and repeated at the end of the 8-week treatment period
Modified Mallet Grading System (MMGS)
Time frame: he assessment will be conducted at the beginning of the treatment and repeated at the end of the 8-week treatment period.
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 21 Aug 2025.
- Individual participant dataSharing planned: No. No individual participant data will be shared
Related trials for Obstetric Brachial Plexus Injury
Recruiting
Development of Diffusion MRI and Tractography Technique for the Detection of Nerve Lesions in Brachial Plexus Injuries
Obstetric Brachial Plexus Palsy
RecruitingObservational study
Evaluation of Pain, Upper Extremity Function, and Social Appearance Anxiety in Adults With Obstetric Brachial Plexus Palsy Who Underwent Shoulder Tendon Transfer Surgery
Brachial Plexus Birth Palsy, Brachial Plexus Palsy
RecruitingObservational study
Validity and Reliability of the Turkish Version of the Impact of Brachial Plexus Injury Questionnaire (IMBPIQ)
Brachial Plexus Birth Palsy, Brachial Plexus Palsy
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.
Çiğdem Öksüz, PhD, Professor, principal investigator
Hacettepe University Faculty of Health Sciences, Department of Occupational Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sensory integration therapy in people with Obstetric Brachial Plexus Injury, run by Hacettepe 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 21 Aug 2025. 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?
Contact elif cimilli, MSc (+905469598168, e.ciminli19@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) (time frame: The assessment will be conducted at the beginning of the treatment and repeated at the end of the 8-week treatment period.). 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 21 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.