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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
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

12 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

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

First Posted
June 20, 2022
Last Updated
June 24, 2022
Sponsor
Hacettepe University
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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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