NCT05431647

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2021

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 20, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2022

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

9 days

First QC Date

June 20, 2022

Last Update Submit

June 24, 2022

Conditions

Keywords

Cerebral PalsyCortical Visual ImpairmentSensory IntegrationMotor FunctionEarly Intervention.

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 COMPARATOR

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

Other: Sensory integration therapy

Control group only Physiotherapy

ACTIVE COMPARATOR

Physiotherapy program 8 weeks 2 days in a week 45 minutes per session Conventional physiotherapy

Other: Sensory integration therapy

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.

Control group only Physiotherapyİntervention group: Physiotherapy and Sensory Integration Therapy

Eligibility Criteria

Age12 Months - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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)

Location

MeSH Terms

Conditions

Cerebral PalsyBlindness, Cortical

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBlindnessVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • mustafa cemali, Phd. student

    hacettepe üniversitesi

    STUDY DIRECTOR

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

Locations