Sensory Integration Therapy in Children With Congenital Brachial Plexus Injury: Developmental Outcomes (SI-BPI)

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.

Study Overview

• Status: Recruiting
• Conditions: Obstetric Brachial Plexus Injury
• Intervention / Treatment: Other: sensory integration therapy

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: elif cimilli, MSc; Phone Number: +905469598168; Email: e.ciminli19@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey
    • Recruiting
    • Hacettepe Univeristy
    • Contact: cigdem oksuz, Professor; Phone Number: +90 533 344 22 85

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; 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.	Other: sensory integration therapy; 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
No Intervention: control group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The assessment will be conducted at the beginning of the treatment and repeated at the end of the 8-week treatment period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	he assessment will be conducted at the beginning of the treatment and repeated at the end of the 8-week treatment period.

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Çiğdem Öksüz, PhD, Professor,, Hacettepe University Faculty of Health Sciences, Department of Occupational Therapy

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 8, 2025
• First Submitted That Met QC Criteria: August 14, 2025
• First Posted (Actual): August 21, 2025

Study Record Updates

• Last Update Posted (Actual): August 21, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Cognitive development; Motor development; sensory integration; obstetric brachial plexus palsy
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: E-68552689-000-00004173157; Hacettepe University (Other Identifier: Hacettepe University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No