Sensory Integration for Infants With Cortical Visual Impairment
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
1 other identifier
interventional
34
1 country
1
Brief Summary
Our study examines the effect of sensory integration training on sensory, motor and oculomotor skills in infants with cortical vision impairment .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2021
CompletedFirst Submitted
Initial submission to the registry
June 20, 2022
CompletedFirst Posted
Study publicly available on registry
June 24, 2022
CompletedJune 27, 2022
June 1, 2022
9 days
June 20, 2022
June 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (2)
Test of Sensory Functions in Infants (TSFI)
30 minute
Alberta Infant Motor Scale (AIMS)
30 minute
Study Arms (2)
İntervention group: Physiotherapy and Sensory Integration Therapy
ACTIVE COMPARATORPhysiotherapy program 8 weeks 2 days in a week 45 minutes per session Conventional physiotherapy Sensory integration therapy program 8 weeks 2 days in a week 45 minutes per session Sensory integration therapy
Control group only Physiotherapy
ACTIVE COMPARATORPhysiotherapy program 8 weeks 2 days in a week 45 minutes per session Conventional physiotherapy
Interventions
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.
Eligibility Criteria
You may qualify if:
- Cerepral palsy
- Cortical visual impairment
- months
You may not qualify if:
- Not participating in treatment regularly
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Occupational Therapy Department
Ankara, Çankaya, 06530, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
mustafa cemali, Phd. student
hacettepe üniversitesi
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Phd. student
Study Record Dates
First Submitted
June 20, 2022
First Posted
June 24, 2022
Study Start
January 6, 2021
Primary Completion
January 15, 2021
Study Completion
June 5, 2021
Last Updated
June 27, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR