Sensory Integration DisorderNCT05431647
Sensory Integration for Infants With Cortical Visual Impairment
A study testing Sensory integration therapy in people with Sensory Integration Disorder, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Our study examines the effect of sensory integration training on sensory, motor and oculomotor skills in infants with cortical vision impairment . Read more about this study
- Who is it for?
- Ages 12 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Sensory Integration Disorder
- What is being tested?
- Sensory integration therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2021to 5 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Cerepral palsy
- Cortical visual impairment
- 12-18 months
Who cannot join
- Not participating in treatment regularly
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Occupational Therapy Department
Ankara, Çankaya, 06530
About this study
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
Our study examines the effect of sensory integration training on sensory, motor and oculomotor skills in infants with cortical vision impairment .
Read the 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).
- Conditions
- Sensory Integration Disorder
- Being tested
- Sensory integration therapy
- Keywords
- Cerebral Palsy, Cortical Visual Impairment, Sensory Integration, Motor Function, Early Intervention.
- Medical subject headings
- Cerebral Palsy, Blindness, Cortical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory integration therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Sensory integration therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 minute
Secondary 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.
Measured: 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.
Measured: 30 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start6 Jan 2021
- Primary completion15 Jan 2021
- Study completion5 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory Integration DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Cemali, Hacettepe University
- Investigators
- mustafa cemali, Phd. student, Study director, hacettepe üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431647
- Sponsor's protocol ID
- 2020-20/494
- Status last verified
- Jun 2022
- First submitted
- 20 Jun 2022
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05431647
- Acronym / sponsor ID
- 2020-20/494
- Conditions
- Sensory Integration Disorder
- Keywords
- Cerebral Palsy, Cortical Visual Impairment, Sensory Integration, Motor Function, Early Intervention.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 5 Jun 2021 (actual)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İntervention group: Physiotherapy and Sensory Integration Therapy | Active comparator | Other: Sensory integration therapyPhysiotherapy 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 comparator | Other: Sensory integration therapyPhysiotherapy program 8 weeks 2 days in a week 45 minutes per session Conventional physiotherapy |
Who may qualify
- Ages
- 12 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Cerepral palsy
- Cortical visual impairment
- 12-18 months
Key exclusion criteria (1 listed)
- Not participating in treatment regularly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory integration therapyThe 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. | Other | Control group only Physiotherapy, İntervention group: Physiotherapy and Sensory Integration Therapy |
Primary outcome
Test of Sensory Functions in Infants (TSFI)
Time frame: 30 minute
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)
Time frame: 30 minute
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.
2 secondary outcomes
Test of Sensory Functions in Infants (TSFI)
Time frame: 30 minute
Alberta Infant Motor Scale (AIMS)
Time frame: 30 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Individual participant dataSharing planned: Yes
Related trials for Sensory Integration Disorder
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Effectiveness of Robot-Assisted Intervention and Sensory Integration Therapy in Enhancing Social-Emotional Skills in Children With Autism
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Awareness Among PT Regarding Sensory Integration Therapy on CP Population
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mustafa cemali, Phd. student study director
hacettepe üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory integration therapy in people with Sensory Integration Disorder, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of Sensory Functions in Infants (TSFI) (time frame: 30 minute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022; AzTrials last refreshed its copy on 1 Nov 2026.