NCT03752697

Brief Summary

The purpose of this study is to investigate the trajectory of metacognitive functioning throughout phases of recovery from neurological insult, and to determine its relationship to rehabilitation compliance and functional outcome. It is hypothesized that metacognitive accuracy improves over time, and is a significant predictor of engagement in rehabilitation activities.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Dec 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress99%
Dec 2018Jun 2026

First Submitted

Initial submission to the registry

September 25, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

December 13, 2018

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

October 29, 2025

Status Verified

October 1, 2025

Enrollment Period

7.5 years

First QC Date

September 25, 2018

Last Update Submit

October 27, 2025

Conditions

Keywords

metacognitionself-assessment

Outcome Measures

Primary Outcomes (1)

  • Change from baseline metamemory performance to completion of rehabilitation

    The computerized metamemory test produces scores that are used to calculate a gamma coefficient, which is a quantitative measure of the individual's metacognitive performance/accuracy.

    At baseline and at end of length of stay in rehabilitative setting (on average 3 months)

Secondary Outcomes (1)

  • Change in rehabilitative engagement

    At baseline and at end of length of stay in rehabilitative setting (on average 3 months)

Study Arms (2)

Neurological injury

Paper and pencil/computerized assessments of cognitive functioning and metacognitive performance will be administered.

Behavioral: metacognitive performance

Healthy control

Paper and pencil/computerized assessments of cognitive functioning and metacognitive performance will be administered.

Behavioral: metacognitive performance

Interventions

Paper and pencil/computerized tests of metacognition

Healthy controlNeurological injury

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

participants in rehabilitation facility and community-dwelling individuals

You may qualify if:

  • history of brain and/or spinal cord injury
  • no history of brain or neurological injury/insult (for healthy control group)
  • fluent in spoken and written English
  • adequate gross motor abilities to provide a button push on a keyboard

You may not qualify if:

  • current/past history of psychiatric illness
  • learning disorder
  • developmental disorder
  • diagnosis of Attention Deficit Disorder/Attention Deficit Hyperactive Disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska-Lincoln

Lincoln, Nebraska, 68588-0308, United States

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Kathy Chiou, Ph.D.

    University of Nebraska Lincoln

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2018

First Posted

November 26, 2018

Study Start

December 13, 2018

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

October 29, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations