NCT05027178

Brief Summary

The Life University Center for Chiropractic Research is conducting a research study to better understand how 12-weeks of chiropractic care differentially affects the post-rehabilitation brain electrical patterns and body movement patterns of individuals who have experienced hemorrhagic versus ischemic stroke The study will involve visits to the Life University Center for Chiropractic Research (CCR) in midtown Atlanta. During the 12 weeks of focused care, chiropractic visits could be several times a week depending on the care plan. In addition to the chiropractic care, individuals will receive a physical examination and three follow-up assessments. The assessments in the CCR will include a non-invasive evaluation of the brain wave patterns using electroencephalography (EEG), completion of a few surveys, a balance assessment and a movement assessment. Qualified individuals will receive study treatment and care at no cost.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

2.2 years

First QC Date

August 27, 2021

Last Update Submit

February 16, 2023

Conditions

Stroke

Outcome Measures

Primary Outcomes (12)

  • Stroke Impact Scale Survey

    Disease specific self-report questionnaire that evaluates disability and health related quality of life post stroke.

    Baseline

  • Stroke Impact Scale Survey

    Disease specific self-report questionnaire that evaluates disability and health related quality of life post stroke.

    4 weeks

  • Stroke Impact Scale Survey

    Disease specific self-report questionnaire that evaluates disability and health related quality of life post stroke.

    8 weeks

  • Stroke Impact Scale Survey

    Disease specific self-report questionnaire that evaluates disability and health related quality of life post stroke.

    12 weeks

  • Resting State Electroencephalography

    EEG assessment

    Baseline

  • Resting State Electroencephalography

    EEG assessment

    4 weeks

  • Resting State Electroencephalography

    EEG assessment

    8 weeks

  • Resting State Electroencephalography

    EEG assessment

    12 weeks

  • Kinematic Assessment of Performance on finger to nose test

    Assessment to measure of dysmetria

    Baseline

  • Kinematic Assessment of Performance on finger to nose test

    Assessment to measure of dysmetria

    4 weeks

  • Kinematic Assessment of Performance on finger to nose test

    Assessment to measure of dysmetria

    8 weeks

  • Kinematic Assessment of Performance on finger to nose test

    Assessment to measure of dysmetria

    12 weeks

Study Arms (2)

Chiropractic care for Ischemic Stroke Patients

EXPERIMENTAL

12 weeks of full spine chiropractic care will be provided to patient. Patients may be asked to present one- two times per week.

Other: Chiropractic Care

Chiropractic care for Hemorrhagic Stroke Patients

EXPERIMENTAL

12 weeks of full spine chiropractic care will be provided to patient. Patients may be asked to present one- two times per week.

Other: Chiropractic Care

Interventions

Chiropractic CareOTHER

Chiropractic care on stroke participants

Chiropractic care for Hemorrhagic Stroke PatientsChiropractic care for Ischemic Stroke Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Post stroke rehabilitation

You may not qualify if:

  • Not experienced sub-arachnoid bleeding within the last 4 weeks, fractures or trauma to the skull, pregnancy, or progressive RA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Life University Center for Chiropractic Research

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Stephanie Sullivan, DC, PhD

    Life Univeristy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data analysis - single blinded
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2021

First Posted

August 30, 2021

Study Start

August 7, 2020

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

February 17, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)