ImPACT Version 4-Touchscreen: Normative and Reliability Study

Not Applicable

Active, not recruiting

• Conditions: Concussion

• Registration Number: NCT05551520
• Lead Sponsor: ImPACT Applications, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2022-02-07
• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-09-20
• Study First Posted: 2022-09-22
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-05
• Primary Completion: 2024-06-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1437

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Validity	12 months	ImPACT Touchscreen performs within normal parameters of ImPACT Online

Secondary Outcome Measures

Name	Time	Method
Reliability	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.

Trial Locations

Locations (1)

ImPACT Applications, Inc.; 🇺🇸 Coralville, Iowa, United States