Sensory integration therapy to support development in babies with birth-related brachial plexus injury
Investigation of the Effects of Sensory Integration Therapy on Sensory, Motor, and Cognitive Development in Children With Congenital Brachial Plexus Injury
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 7 Months to 35 Months |
| Sex | All |
| Sponsor | Hacettepe University Academic / other |
| Locations | 1 site (Ankara) |
| Trial ID | NCT07134049 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Ankara
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.