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Completed

NCT Number: NCT05431647

Sensory Integration for Infants With Cortical Visual Impairment

Our study examines the effect of sensory integration training on sensory, motor and oculomotor skills in infants with cortical vision impairment .

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Key information

Conditions

Sensory Integration Disorder Blindness Blindness, Cortical Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

12 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Occupational Therapy Department

Ankara, Çankaya, 06530, Turkey (Türkiye)

About this study

Cortical vision impairment (CVI) and Cerebral Palsy (CP) lead to decrement in sensory and motor functions of infants. The current study examined the effectiveness of sensory integration interventions on sensory, motor, and oculomotor skills in infants with cortical vision impairment. Thirty-four infants with CVI and CP aged 12-18 months were enrolled to the study. The infants were randomly divided into 2 groups as the control and intervention groups. The intervention group took sensory integration intervention 2 days a week for 8 weeks in addition to conventional physiotherapy two days a week for eight weeks. The control group only received the conventional physiotherapy program 2 days a week for 8 weeks. The duration of the treatment sessions were 45 minutes for both interventions. Before and after the intervention, sensory processing functions were evaluated with the Test of Sensory Functions in Infants (TSFI) and motor functions were evaluated with the Alberta Infant Motor Scale (AIMS).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cerepral palsy
  • Cortical visual impairment
  • 12-18 months

Exclusion criteria

  • Not participating in treatment regularly

Treatment and study plan

Sensory Integration Therapy

Other

The individuals were divided into two as randomized controlled. Both physiotherapy and sensory integration therapy were applied to the intervention group. Each treatment was applied as 2 sessions per week, 2 days a week for 8 weeks. In the control group, only physiotherapy treatment was applied for 8 weeks, 2 days a week, 2 sessions per week.

Primary outcomes

  1. Test of Sensory Functions in Infants (TSFI)

    Time frame: 30 minute

    The TSFI consists of 24 items. It was developed to evaluate sensory processing problems in infants aged 4 to 18 months. The test consists of five subsections and 24 items.

  2. Alberta Infant Motor Scale (AIMS)

    Time frame: 30 minute

    The AIMS gives information about the gross motor development of infants whose corrected ages are between 0 and 18 months. In AIMS, the age of infants is calculated as the corrected age. It allows the family and the clinician to obtain information about the infant's current motor development and to compare the motor development before and after treatment.

Secondary outcomes

  1. Test of Sensory Functions in Infants (TSFI)

    Time frame: 30 minute

    The TSFI consists of 24 items. It was developed to evaluate sensory processing problems in infants aged 4 to 18 months. The test consists of five subsections and 24 items.

  2. Alberta Infant Motor Scale (AIMS)

    Time frame: 30 minute

    The AIMS gives information about the gross motor development of infants whose corrected ages are between 0 and 18 months. In AIMS, the age of infants is calculated as the corrected age. It allows the family and the clinician to obtain information about the infant's current motor development and to compare the motor development before and after treatment.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

The Effectiveness of Sensory Integration Interventions on Motor and Sensory Functions in Infants With Cortical Vision Impairment and Cerebral Palsy: A Single Blind Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 24, 2022
Registry last updated
Jun 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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