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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05431647
Other study ID # 2020-20/494
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 6, 2021
Est. completion date June 5, 2021

Study information

Verified date June 2022
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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).


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date June 5, 2021
Est. primary completion date January 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months to 18 Months
Eligibility Inclusion Criteria - Cerepral palsy - Cortical visual impairment - 12-18 months Exclusion Criteria - Not participating in treatment regularly

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Sensory integration therapy
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.

Locations

Country Name City State
Turkey Occupational Therapy Department Ankara Çankaya

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Test of Sensory Functions in Infants (TSFI) 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. 30 minute
Primary Alberta Infant Motor Scale (AIMS) 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. 30 minute
Secondary Test of Sensory Functions in Infants (TSFI) 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. 30 minute
Secondary Alberta Infant Motor Scale (AIMS) 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. 30 minute
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