ImPACT Version 4-Touchscreen: Normative and Reliability Study

July 3, 2023 updated by: ImPACT Applications, Inc.
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

1437

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Coralville, Iowa, United States, 52241
        • ImPACT Applications, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Normative
ImPACT will be administered to participant's for a baseline test.
Device: Normative
ImPACT will be administered at baseline testing
Other: Reliability
ImPACT will be administered to participant's within 60 days of baseline test.
Device: Reliability
ImPACT will be administered again within 60 days of baseline test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validity
Time Frame: 12 months
ImPACT Touchscreen performs within normal parameters of ImPACT Online
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reliability
Time Frame: Baseline test will be administered at enrollment and re-test will be administered within 60 days of baseline test.
Reliability will be established through a test/re-test. ImPACT Touchscreen will be administered at 2 time points to establish results should be stable over time.
Baseline test will be administered at enrollment and re-test will be administered within 60 days of baseline test.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImPACT Applications, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

March 29, 2022

First Submitted That Met QC Criteria

September 20, 2022

First Posted (Actual)

September 22, 2022

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • QPR-21-20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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