Sensory Integration for Infants With Cortical Visual Impairment
Primary Purpose
Sensory Integration Disorder
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sensory integration therapy
Sponsored by
About this trial
This is an interventional treatment trial for Sensory Integration Disorder focused on measuring Cerebral Palsy, Cortical Visual Impairment, Sensory Integration, Motor Function, Early Intervention.
Eligibility Criteria
Inclusion Criteria
- Cerepral palsy
- Cortical visual impairment
- 12-18 months
Exclusion Criteria
- Not participating in treatment regularly
Sites / Locations
- Occupational Therapy Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
İntervention group: Physiotherapy and Sensory Integration Therapy
Control group only Physiotherapy
Arm Description
Physiotherapy 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
Physiotherapy program 8 weeks 2 days in a week 45 minutes per session Conventional physiotherapy
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05431647
Brief Title
Sensory Integration for Infants With Cortical Visual Impairment
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 6, 2021 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
June 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Our study examines the effect of sensory integration training on sensory, motor and oculomotor skills in infants with cortical vision impairment .
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensory Integration Disorder
Keywords
Cerebral Palsy, Cortical Visual Impairment, Sensory Integration, Motor Function, Early Intervention.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
İntervention group: Physiotherapy and Sensory Integration Therapy
Arm Type
Active Comparator
Arm Description
Physiotherapy 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
Arm Title
Control group only Physiotherapy
Arm Type
Active Comparator
Arm Description
Physiotherapy program
8 weeks 2 days in a week 45 minutes per session Conventional physiotherapy
Intervention Type
Other
Intervention Name(s)
Sensory integration therapy
Intervention Description
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 Outcome Measure Information:
Title
Test of Sensory Functions in Infants (TSFI)
Description
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.
Time Frame
30 minute
Title
Alberta Infant Motor Scale (AIMS)
Description
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.
Time Frame
30 minute
Secondary Outcome Measure Information:
Title
Test of Sensory Functions in Infants (TSFI)
Description
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.
Time Frame
30 minute
Title
Alberta Infant Motor Scale (AIMS)
Description
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.
Time Frame
30 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Cerepral palsy
Cortical visual impairment
12-18 months
Exclusion Criteria
Not participating in treatment regularly
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mustafa cemali, Phd. student
Organizational Affiliation
hacettepe üniversitesi
Official's Role
Study Director
Facility Information:
Facility Name
Occupational Therapy Department
City
Ankara
State/Province
Çankaya
ZIP/Postal Code
06530
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Sensory Integration for Infants With Cortical Visual Impairment
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