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Recruiting NCT07134049

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

No phase Interventional Obstetric Brachial Plexus Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: sensory integration therapy.
Who it may be relevant to
Registry conditions: Obstetric Brachial Plexus Injury. Basic parameters: 7 months — 35 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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,

Primary outcome measures

  • 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.]
Secondary outcome measures (3)
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Hacettepe Univeristy — Ankara

Identifiers

NCT: NCT07134049 · E-68552689-000-00004173157 · Hacettepe University

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗