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NCT Number: NCT07134049

Sensory Integration Therapy in Children With Congenital Brachial Plexus Injury: Developmental Outcomes

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.

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Key information

Conditions

Obstetric Brachial Plexus Injury

Age range

7 month–35 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe Univeristy

Ankara, Turkey (Türkiye)

Location status: Recruiting

Location contact

cigdem oksuz, Professor

CONTACT

+90 533 344 22 85

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Severe visual or hearing impairment preventing participation in assessments Participation in another experimental rehabilitation program within the last 3 months

Treatment and study plan

Sensory Integration Therapy

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

    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.

  2. 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

    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.

  3. 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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

elif cimilli, MSc

CONTACT

[email protected]

+905469598168

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Investigation of the Effects of Sensory Integration Therapy on Sensory, Motor, and Cognitive Development in Children With Congenital Brachial Plexus Injury

Acronym: SI-BPI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2025
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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