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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-35
SponsorHacettepe University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • sensory integration therapy

    Other intervention

    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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: intervention groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

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 outcomes

1

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.

Time frame
The assessment will be conducted at the beginning of the treatment and repeated at the end of the 8-week treatment period.
2

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.

Time frame
The assessment will be conducted at the beginning of the treatment and repeated at the end of the 8-week treatment period
3

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.

Time frame
he assessment will be conducted at the beginning of the treatment and repeated at the end of the 8-week treatment period.

Other outcomes

Sponsors and contacts

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