HydrocephalusNCT03595033
Hydrocephalus iPad-App Based Intervention Study
A study testing iPad app-based intervention in people with Hydrocephalus and Hydrocephaly, run by Children's Hospital Medical Center, Cincinnati.
Trial summary
This is a pilot study examining the feasibility and efficacy of using Apple iPad applications ("apps") during therapy interventions that target visual motor, visual attention, and visual-spatial reasoning skills in school age children who were previously treated surgically for hydrocephalus. Read more about this study
- Who is it for?
- Ages 6 to 6 years
- Conditions the study is for
- Hydrocephalus, Hydrocephaly, Hydrocephalus in Children
- What is being tested?
- iPad app-based intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 24 Nov 2015to 28 Dec 2018
- 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 6 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children, aged 6 to 17 years, with hydrocephalus who have had a surgical intervention
- Deficits in 2 of more of the following neuropsychological testing categories: visual motor, visual attention, or visual reasoning.
Who cannot join
- Shunt revision within the past one year
- MRI-sensitive programmable shunt or any other MRI-sensitive implant
- Braces or other dental hardware that would interfere with the quality of MRI images (participants with braces are only excluded from the MRI portion of the study)
- Intellectual disability: IQ < 70
- Deficits in one or none of the three following neuropsychological testing categories: visual motor, visual attention, or visual reasoning
- Age 18 years or greater
- Non-English speaking: We will not enroll non-English speaking participants because the iPad applications are not readily available in other languages. All neuropsychological testing materials are also in English.
About this study
Official title: iPad Application Based Therapy Intervention in School Age Children With Surgically Treated Hydrocephalus
This is a pilot study examining the feasibility and efficacy of using Apple iPad applications ("apps") during therapy interventions that target visual motor, visual attention, and visual-spatial reasoning skills in school age children who were previously treated surgically for hydrocephalus. Each subject will participate in an initial assessment and baseline MRI, followed by 6-weeks of iPad app-based interventions, and finally a follow-up assessment and a follow-up MRI.
Read the detailed description
Long term visuospatial and visuomotor functional deficits are common in pediatric patients with surgically treated hydrocephalus. The deficits are often mild/moderate at early school age although the gap may widen as the children grow older, leading to increasing adverse impact on school performance and academic achievement. The proposed study will generate initial pilot data for the usage of iPad application based therapy intervention for the treatment of cognitive deficits common to pediatric hydrocephalus. It will help determine the optimal intensity and duration of training protocol adapted for the study. In addition, the sensitivity of neuroimaging (DTI) in response to the therapy will be assessed and validated as a biomarker that reflects the neuroanatomical alterations underpinning the outcome changes. This study will generate the crucial data to support the design of future Phase III clinical trial with the long term goal as changing the current standard of care in order to prevent neurocognitive and sensorimotor deficits before the injury to neural circuitry becomes irreversible.
The participants who meet the inclusion criteria and do not opt-out of participation will be called by a study coordinator to ensure eligibility and to schedule the initial assessment date. Participation in this study will include 8-10 study visits. These visits include 2 neuropsychological assessments, 2 MRI visits, and 6 weekly visits during intervention phase. MRI visit can be combined with the neuropsychological assessment visit if possible at both the pre- and post intervention time points.
- Conditions
- Hydrocephalus, Hydrocephaly, Hydrocephalus in Children
- Being tested
- iPad app-based intervention
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPad app-based interventionDevice
The 1-hour of home based intervention will break into three 20-min sessions, each including iPad apps targeting one of the three domains of deficits: visual attention, visual-spatial reasoning, and visual-motor skills.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Phase | Experimental | Throughout the intervention phase, participants will attend weekly intervention visits. During these visits, an occupational therapist (OT) will educate the participant and their caregiver on the therapy plan which includes the iPad apps to be completed during the week. The participants will be asked to complete their therapy plan for 1 hour per day at home, 4 days per week. Receives: Device: iPad app-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
General intellectual functioning, including visual-spatial reasoning
The Perceptual Reasoning Index (PRI) of the revision of the Wechsler Abbreviated Scale of Intelligence (WASI-II). PRI includes the subtests Block Design and Matrix Reasoning. The Raw scores of the subtests are converted to T-scores, which are summed for a Sum of T-scores for Perceptual Reasoning. The Sum of T-scores for Perceptual Reasoning is converted to a Composite Score of the PRI, which can be used to find the Percentile Rank. The Block Design raw scores range from 0-51 and the Matrix Reasoning raw scores range from 0-23. The T-score ranges are from 20-54. The Composite Scores range from 40-160.The higher the scores of the subtests, the higher the score on the PRI, the greater the subject's ability to analyze and synthesize abstract visual stimuli and the subject's fluid intelligence, broad visual intelligence, classification and spatial ability, knowledge of part-whole relationships, simultaneous processing, and perceptual organization.
Measured: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
Basic visual perception, visual-motor integration, and graphomotor skills
The Beery-Buktenica Developmental Test of Visual Motor Integration 6th Edition (Beery VMI). The composite score is the sum of the scores of three subtests: Visual-Motor Integration, Visual Perception, and Motor Coordination. The scores for the subtests are calculated using pre-formatted tables to determine the standard score, scaled score, and percentile based off of the raw score. The composite score has a mean of 100 and a standard deviation of 15 for all ages groups, and are based on the means of raw score distribution. The higher the score, the higher the percentile, the greater the subject's ability for visual perception, visual motor-integration, and graphomotor skills.
Measured: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
Visual-spatial processing
The Arrows subtest of the revision of A Developmental Neuropsychological Assessment (NEPSY-II), designed to assess the ability to judge line orientation. The Arrows subtest-level scores range from 1-19, with a low score indicating poor visuospatial skills, while a high score indicates excellent visuospatial skills.
Measured: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
Visual-spatial processing and mental rotation
The Geometric Figures subtest of the revision of A Developmental Neuropsychological Assessment (NEPSY-II), designed to assess mental rotation, visuospatial analysis, and attention to detail. The Geometric Figures subtest-level scores range from 1-19, with a low score indicating difficulty with visuospatial perception, including mental rotation and with a high score indicating excellent visuospatial perception.
Measured: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
Selective visual attention
The Cancellation subtest of the revision of the Wechsler Intelligence Scale for Children (WISC-IV), designed to measure processing speed. The Raw Score is converted to a Scaled Score (1-19), which is converted to a Percentile Rank. The higher the raw score, the higher the Scaled Score, and the Percentile Rank. The higher the score, the better the visual processing speed.
Measured: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
Visual-spatial decision making and visual-motor speed
Coding subtest of the revision of the Wechsler Intelligence Scale for Children (WISC-IV), designed to measure visual-motor speed and complexity and motor coordination. The Raw Score is converted to a Scaled Score (1-19), which is converted to a Percentile Rank. The higher the raw score, the higher the Scaled Score, and the Percentile Rank. The higher the score, the better the visual-spatial and visual-motor skills.
Measured: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
Fine motor dexterity
The Purdue Pegboard test, designed to measure manual dexterity and bimanual coordination.The test is comprised of 5 scores, each of the subtests are timed. Scores are continuous, the higher the score the greater the subjet's manual dexterity and bimanual coordination.
Measured: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
Visual-motor control
The Visuomotor Precision subtest of the revision of A Developmental Neuropsychological Assessment (NEPSY-II), designed to assess graphomotor speed and accuracy. The Visuomotor Precision subtest-level scores range from 1-19, with a low score indicating difficulty with visuomotor control and with a high score indicating excellent visuomotor skills.
Measured: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
Neuroanatomical alterations in brain tissue structure
Diffusion Tensor Imaging (DTI) scan: a spin-echo EPI DTI sequence (FOV = 240 x 240 mm, matrix = 96 x 96, in-plane resolution = 2.5 x 2.5 mm, slice thickness = 2.5 mm, number of slices =76, TR/TE = 9400/93.2 msec; sense factor = 2; NEX = 2). DTI measures anisotropic diffusion properties via diffusion indices.
Measured: Baseline MRI and Follow-up MRI (6-8 weeks after Baseline MRI)
Secondary outcomes (1)
Adherence to the training plan
Adherence to the training plan will be evaluated using performance data collected by the apps. If performance data is not available from the apps, the participants will be given an activity log to record their usage time, games played, and scores obtained. Eighty-percent completion of the recommended time (24 hrs = 6 wks x 4 days/wk x 1 hr/day) is the goal of the study.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start24 Nov 2015
- Primary completion28 Dec 2018
- Study completion28 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen L Harpster, PhD, OTR/L, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595033
- Sponsor's protocol ID
- CIN_HCPiPad_001
- Status last verified
- Feb 2021
- First submitted
- 29 May 2018
- Last updated
- 26 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iPad Application Based Therapy Intervention in School Age Children With Surgically Treated Hydrocephalus
- ClinicalTrials.gov ID
- NCT03595033
- Acronym / sponsor ID
- CIN_HCPiPad_001
- Conditions
- Hydrocephalus, Hydrocephaly, Hydrocephalus in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 24 Nov 2015 (actual)
- Primary completion
- 28 Dec 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 23 Jul 2018 (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.
This is a pilot study examining the feasibility and efficacy of using Apple iPad applications ("apps") during therapy interventions that target visual motor, visual attention, and visual-spatial reasoning skills in school age children who were previously treated surgically for hydrocephalus. Each subject will participate in an initial assessment and baseline MRI, followed by 6-weeks of iPad app-based interventions, and finally a follow-up assessment and a follow-up MRI.
Detailed description
Long term visuospatial and visuomotor functional deficits are common in pediatric patients with surgically treated hydrocephalus. The deficits are often mild/moderate at early school age although the gap may widen as the children grow older, leading to increasing adverse impact on school performance and academic achievement. The proposed study will generate initial pilot data for the usage of iPad application based therapy intervention for the treatment of cognitive deficits common to pediatric hydrocephalus. It will help determine the optimal intensity and duration of training protocol adapted for the study. In addition, the sensitivity of neuroimaging (DTI) in response to the therapy will be assessed and validated as a biomarker that reflects the neuroanatomical alterations underpinning the outcome changes. This study will generate the crucial data to support the design of future Phase III clinical trial with the long term goal as changing the current standard of care in order to prevent neurocognitive and sensorimotor deficits before the injury to neural circuitry becomes irreversible.
The participants who meet the inclusion criteria and do not opt-out of participation will be called by a study coordinator to ensure eligibility and to schedule the initial assessment date. Participation in this study will include 8-10 study visits. These visits include 2 neuropsychological assessments, 2 MRI visits, and 6 weekly visits during intervention phase. MRI visit can be combined with the neuropsychological assessment visit if possible at both the pre- and post intervention time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Phase | Experimental | Device: iPad app-based interventionThroughout the intervention phase, participants will attend weekly intervention visits. During these visits, an occupational therapist (OT) will educate the participant and their caregiver on the therapy plan which includes the iPad apps to be completed during the week. The participants will be asked to complete their therapy plan for 1 hour per day at home, 4 days per week. |
Who may qualify
- Ages
- 6 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children, aged 6 to 17 years, with hydrocephalus who have had a surgical intervention
- Deficits in 2 of more of the following neuropsychological testing categories: visual motor, visual attention, or visual reasoning.
Key exclusion criteria (7 listed)
- Shunt revision within the past one year
- MRI-sensitive programmable shunt or any other MRI-sensitive implant
- Braces or other dental hardware that would interfere with the quality of MRI images (participants with braces are only excluded from the MRI portion of the study)
- Intellectual disability: IQ < 70
- Deficits in one or none of the three following neuropsychological testing categories: visual motor, visual attention, or visual reasoning
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 |
|---|---|---|
| iPad app-based interventionThe 1-hour of home based intervention will break into three 20-min sessions, each including iPad apps targeting one of the three domains of deficits: visual attention, visual-spatial reasoning, and visual-motor skills. | Device | Intervention Phase |
Primary outcome
General intellectual functioning, including visual-spatial reasoning
Time frame: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
The Perceptual Reasoning Index (PRI) of the revision of the Wechsler Abbreviated Scale of Intelligence (WASI-II). PRI includes the subtests Block Design and Matrix Reasoning. The Raw scores of the subtests are converted to T-scores, which are summed for a Sum of T-scores for Perceptual Reasoning. The Sum of T-scores for Perceptual Reasoning is converted to a Composite Score of the PRI, which can be used to find the Percentile Rank. The Block Design raw scores range from 0-51 and the Matrix Reasoning raw scores range from 0-23. The T-score ranges are from 20-54. The Composite Scores range from 40-160.The higher the scores of the subtests, the higher the score on the PRI, the greater the subject's ability to analyze and synthesize abstract visual stimuli and the subject's fluid intelligence, broad visual intelligence, classification and spatial ability, knowledge of part-whole relationships, simultaneous processing, and perceptual organization.
Basic visual perception, visual-motor integration, and graphomotor skills
Time frame: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
The Beery-Buktenica Developmental Test of Visual Motor Integration 6th Edition (Beery VMI). The composite score is the sum of the scores of three subtests: Visual-Motor Integration, Visual Perception, and Motor Coordination. The scores for the subtests are calculated using pre-formatted tables to determine the standard score, scaled score, and percentile based off of the raw score. The composite score has a mean of 100 and a standard deviation of 15 for all ages groups, and are based on the means of raw score distribution. The higher the score, the higher the percentile, the greater the subject's ability for visual perception, visual motor-integration, and graphomotor skills.
Visual-spatial processing
Time frame: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
The Arrows subtest of the revision of A Developmental Neuropsychological Assessment (NEPSY-II), designed to assess the ability to judge line orientation. The Arrows subtest-level scores range from 1-19, with a low score indicating poor visuospatial skills, while a high score indicates excellent visuospatial skills.
Visual-spatial processing and mental rotation
Time frame: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
The Geometric Figures subtest of the revision of A Developmental Neuropsychological Assessment (NEPSY-II), designed to assess mental rotation, visuospatial analysis, and attention to detail. The Geometric Figures subtest-level scores range from 1-19, with a low score indicating difficulty with visuospatial perception, including mental rotation and with a high score indicating excellent visuospatial perception.
Selective visual attention
Time frame: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
The Cancellation subtest of the revision of the Wechsler Intelligence Scale for Children (WISC-IV), designed to measure processing speed. The Raw Score is converted to a Scaled Score (1-19), which is converted to a Percentile Rank. The higher the raw score, the higher the Scaled Score, and the Percentile Rank. The higher the score, the better the visual processing speed.
Visual-spatial decision making and visual-motor speed
Time frame: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
Coding subtest of the revision of the Wechsler Intelligence Scale for Children (WISC-IV), designed to measure visual-motor speed and complexity and motor coordination. The Raw Score is converted to a Scaled Score (1-19), which is converted to a Percentile Rank. The higher the raw score, the higher the Scaled Score, and the Percentile Rank. The higher the score, the better the visual-spatial and visual-motor skills.
Fine motor dexterity
Time frame: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
The Purdue Pegboard test, designed to measure manual dexterity and bimanual coordination.The test is comprised of 5 scores, each of the subtests are timed. Scores are continuous, the higher the score the greater the subjet's manual dexterity and bimanual coordination.
Visual-motor control
Time frame: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
The Visuomotor Precision subtest of the revision of A Developmental Neuropsychological Assessment (NEPSY-II), designed to assess graphomotor speed and accuracy. The Visuomotor Precision subtest-level scores range from 1-19, with a low score indicating difficulty with visuomotor control and with a high score indicating excellent visuomotor skills.
Neuroanatomical alterations in brain tissue structure
Time frame: Baseline MRI and Follow-up MRI (6-8 weeks after Baseline MRI)
Diffusion Tensor Imaging (DTI) scan: a spin-echo EPI DTI sequence (FOV = 240 x 240 mm, matrix = 96 x 96, in-plane resolution = 2.5 x 2.5 mm, slice thickness = 2.5 mm, number of slices =76, TR/TE = 9400/93.2 msec; sense factor = 2; NEX = 2). DTI measures anisotropic diffusion properties via diffusion indices.
1 secondary outcome
Adherence to the training plan
Time frame: 6 weeks
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 26 Feb 2021.
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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.
Karen L Harpster, PhD, OTR/L principal investigator
Children's Hospital Medical Center, Cincinnati
Questions about this trial
What is this clinical trial studying?
A study testing iPad app-based intervention in people with Hydrocephalus and Hydrocephaly, run by Children's Hospital Medical Center, Cincinnati.
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 2 inclusion and 7 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 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
General intellectual functioning, including visual-spatial reasoning (time frame: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)). The study lists 9 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 26 Feb 2021.