CompletedNot Applicable

Hydrocephalus iPad-App Based Intervention Study

14 participantsStarted 2015-11-24

Plain-language 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. 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.

Who can participate

Age range

6 Years – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

General intellectual functioning, including visual-spatial reasoning

Timeframe: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)

Basic visual perception, visual-motor integration, and graphomotor skills

Timeframe: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)

Visual-spatial processing

Timeframe: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)

Visual-spatial processing and mental rotation

Timeframe: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)

Selective visual attention

Timeframe: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)

Visual-spatial decision making and visual-motor speed

Timeframe: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)

Trial details

NCT IDNCT03595033

SponsorChildren's Hospital Medical Center, Cincinnati

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-28

View on ClinicalTrials.gov More Hydrocephalus trials

Plain-language summary

Who can participate

Age range

6 Years – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

General intellectual functioning, including visual-spatial reasoning

Timeframe: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)

Basic visual perception, visual-motor integration, and graphomotor skills

Timeframe: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)

Visual-spatial processing

Timeframe: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)

Visual-spatial processing and mental rotation

Timeframe: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)

Selective visual attention

Timeframe: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)

Visual-spatial decision making and visual-motor speed

Timeframe: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)