ImPACT Version 4-Touchscreen: Normative and Reliability Study

Concussion Clinical Trial

Official title:

ImPACT Version 4-Touchscreen: Normative and Reliability Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05551520
• Other study ID #: QPR-21-20
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 7, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: July 2023
• Source: ImPACT Applications, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1437
• Est. completion date: October 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Concussion

Intervention

Device:
• Normative
ImPACT will be administered at baseline testing
• Reliability
ImPACT will be administered again within 60 days of baseline test

Locations

Country	Name	City	State
United States	ImPACT Applications, Inc.	Coralville	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
ImPACT Applications, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity	ImPACT Touchscreen performs within normal parameters of ImPACT Online	12 months
Secondary	Reliability	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.