Clinical trial Recruiting at 1 site Interventional Ages 7 Months to 35 Months

Sensory integration therapy to support development in babies with birth-related brachial plexus injury

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

Run by Hacettepe University · NCT07134049 · Data updated 2026-11-12

This trial will test whether weekly sensory integration therapy helps children aged 7 to 35 months with congenital brachial plexus injury improve sensory, motor, and cognitive development.

Quick facts

Study typeInterventional
Ages7 Months to 35 Months
SexAll
Enrollment30 (estimated)
SponsorHacettepe University
Academic / other
Locations1 site (Ankara)
StatusRecruiting
StartedJune 23, 2025
Main results expectedJuly 31, 2026
Study endsDecember 31, 2026
Registry record updatedAugust 21, 2025
Trial IDNCT07134049 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children aged 7 to 35 months with a confirmed diagnosis of obstetric brachial plexus injury, no additional neurological, psychiatric, or muscular disorders, and with parental written consent are ideal candidates.

Probably not a fit

Children with severe visual or hearing impairment, diagnosed cognitive disorders preventing participation in assessments, additional neurological or muscular diagnoses, or recent participation in another experimental rehabilitation program may not receive benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Sensory integration therapy is a play-based intervention that provides graded tactile, vestibular, proprioceptive, visual, and auditory experiences to improve sensory processing and motor planning. This interventional study enrolls children aged 7 to 35 months with confirmed obstetric brachial plexus injury and no other major neurological or cognitive disorders. Participants in the intervention group will receive individualized sensory integration therapy once a week for eight weeks in addition to routine physiotherapy, with developmental outcomes measured using standardized assessment tools before and after the program. The study compares changes in sensory, motor, and cognitive measures to see if adding sensory integration therapy supports overall developmental progress.

Why it matters

Potential benefit: If successful, the therapy could improve sensory processing, motor skills, and early cognitive development, leading to better functional outcomes for affected children.

How similar studies have gone: Sensory integration approaches have been used in other pediatric neurodevelopmental conditions with mixed results, but there is limited prior research specifically testing this therapy for congenital brachial plexus injury.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Hacettepe Univeristy
    Ankara, Turkey (Türkiye)
    Recruiting

Study contacts

  • Principal investigator: Çiğdem Öksüz, PhD, Professor, — Hacettepe University Faculty of Health Sciences, Department of Occupational Therapy
  • Study coordinator: elif cimilli, MSc
  • Email: e.ciminli19@gmail.com
  • Phone: +905469598168

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.