NCT03399929

Brief Summary

Investigators will determine the long-lasting effects of post-acute rehabilitation after traumatic brain injury and stroke. Investigators will also evaluate if the beneficial effects of rehabilitation continue after discharge from a rehabilitative program.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
24mo left

Started May 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress83%
May 2016May 2028

Study Start

First participant enrolled

May 4, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2028

Expected
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

10 years

First QC Date

January 8, 2018

Last Update Submit

July 18, 2022

Conditions

Keywords

RehabilitationLong term outcome

Outcome Measures

Primary Outcomes (4)

  • Effects of rehabilitation on long term occupational Status after injury

    Occupational Status Questionnaire

    1 to 10 years

  • Effects of rehabilitation on long term cognitive function after injury

    Brief Test of Adult Cognition by Telephone

    1 to 10 years

  • Effects of rehabilitation on long term disability function after injury

    Supervision Rating Scale and Disability Rating Scale

    1 to 10 years

  • Effects of rehabilitation on long term quality of life after injury

    Quality of Life in Neurological Disorders Measures (NeuroQOL)

    1 to 10 years

Secondary Outcomes (1)

  • Effects of rehabilitation on long term health after injury

    1 to 10 years

Other Outcomes (1)

  • Effects of rehabilitation on post mortem health after injury

    1 to 10 years

Study Arms (4)

TBI + Rehabilitation

Traumatic Brain Injury patients that received post acute rehabilitation

Other: Post Acute Rehabiltation

TBI + No Rehabilitation

Traumatic Brain Injury patients that did not receive post acute rehabilitation

CVA + Rehabilitation

Stroke patients that received post acute rehabilitation

Other: Post Acute Rehabiltation

CVA + No Rehabilitation

Stroke patients that did not received post acute rehabilitation

Interventions

CVA + RehabilitationTBI + Rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult subjects with a traumatic brain injury or stroke

You may qualify if:

  • Endured a traumatic brain injury or stroke
  • Subject or caretaker should be Fluent in English

You may not qualify if:

  • Diagnosis of degenerative neurological disease prior to sustaining stroke or traumatic brain injury
  • b) A history of major psychosis as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-V) prior to sustaining stroke or traumatic brain injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Neuro Skills

Encino, California, 91436, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, TraumaticStroke

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Study Officials

  • Grace S Griesbach, PhD

    Centre for Neuro Skills

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace S Griesbach, PhD

CONTACT

Stefanie Howell, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 17, 2018

Study Start

May 4, 2016

Primary Completion

May 4, 2026

Study Completion (Estimated)

May 4, 2028

Last Updated

July 20, 2022

Record last verified: 2022-07

Locations