ImPACT Version 4-Touchscreen: Normative and Reliability Study

NCT ID: NCT05551520

Last Updated: 2023-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1437 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-07

Study Completion Date

2024-10-01

Brief Summary

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This research study is designed to establish normative database and reliability of ImPACT for adolescents and adults ages 12 through 80 to expand the use of devices to include touchscreen.

Detailed Description

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This research study is designed to establish normative database and reliability of ImPACT for adolescents and adults ages 12 through 80 to expand the use of devices to include touchscreen. Enrollment will be 900 participants.

Conditions

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Concussion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Normative

ImPACT will be administered to participant's for a baseline test.

Group Type OTHER

Normative

Intervention Type DEVICE

ImPACT will be administered at baseline testing

Reliability

ImPACT will be administered to participant's within 60 days of baseline test.

Group Type OTHER

Reliability

Intervention Type DEVICE

ImPACT will be administered again within 60 days of baseline test

Interventions

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Normative

ImPACT will be administered at baseline testing

Intervention Type DEVICE

Reliability

ImPACT will be administered again within 60 days of baseline test

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age 12-80
2. Primary English speaking or fluent in English

Exclusion Criteria

1. Documentation of a known special education diagnosis other than a 504 designation.
2. History of concussion less than 6 months to the study participation
3. Known physical (e.g., visual impairment not fixable by usual means, such as glasses) or psychological impairment (ADHD, LDD, etc.) that would affect their ability to perform the test.
Minimum Eligible Age

12 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ImPACT Applications, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ImPACT Applications, Inc.

Coralville, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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QPR-21-20

Identifier Type: -

Identifier Source: org_study_id

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