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Stroke Patients Receiving Chiropractic Care Post-rehabilitation

Primary Purpose

Stroke

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chiropractic Care
Sponsored by
Life University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Post stroke rehabilitation

Exclusion Criteria:

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

Sites / Locations

  • Life University Center for Chiropractic Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Chiropractic care for Ischemic Stroke Patients

Chiropractic care for Hemorrhagic Stroke Patients

Arm Description

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

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

Outcomes

Primary Outcome Measures

Stroke Impact Scale Survey
Disease specific self-report questionnaire that evaluates disability and health related quality of life post stroke.
Stroke Impact Scale Survey
Disease specific self-report questionnaire that evaluates disability and health related quality of life post stroke.
Stroke Impact Scale Survey
Disease specific self-report questionnaire that evaluates disability and health related quality of life post stroke.
Stroke Impact Scale Survey
Disease specific self-report questionnaire that evaluates disability and health related quality of life post stroke.
Resting State Electroencephalography
EEG assessment
Resting State Electroencephalography
EEG assessment
Resting State Electroencephalography
EEG assessment
Resting State Electroencephalography
EEG assessment
Kinematic Assessment of Performance on finger to nose test
Assessment to measure of dysmetria
Kinematic Assessment of Performance on finger to nose test
Assessment to measure of dysmetria
Kinematic Assessment of Performance on finger to nose test
Assessment to measure of dysmetria
Kinematic Assessment of Performance on finger to nose test
Assessment to measure of dysmetria

Secondary Outcome Measures

Full Information

First Posted
August 27, 2021
Last Updated
February 16, 2023
Sponsor
Life University
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1. Study Identification

Unique Protocol Identification Number
NCT05027178
Brief Title
Stroke Patients Receiving Chiropractic Care Post-rehabilitation
Official Title
Phenotypic Comparison of Ischemic and Hemorrhagic Stroke Patients Receiving Chiropractic Care Post-rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
The study is being reformatted and will have a different protocol for the relaunch.
Study Start Date
August 7, 2020 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Life University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Masking Description
Data analysis - single blinded
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chiropractic care for Ischemic Stroke Patients
Arm Type
Experimental
Arm Description
12 weeks of full spine chiropractic care will be provided to patient. Patients may be asked to present one- two times per week.
Arm Title
Chiropractic care for Hemorrhagic Stroke Patients
Arm Type
Experimental
Arm Description
12 weeks of full spine chiropractic care will be provided to patient. Patients may be asked to present one- two times per week.
Intervention Type
Other
Intervention Name(s)
Chiropractic Care
Intervention Description
Chiropractic care on stroke participants
Primary Outcome Measure Information:
Title
Stroke Impact Scale Survey
Description
Disease specific self-report questionnaire that evaluates disability and health related quality of life post stroke.
Time Frame
Baseline
Title
Stroke Impact Scale Survey
Description
Disease specific self-report questionnaire that evaluates disability and health related quality of life post stroke.
Time Frame
4 weeks
Title
Stroke Impact Scale Survey
Description
Disease specific self-report questionnaire that evaluates disability and health related quality of life post stroke.
Time Frame
8 weeks
Title
Stroke Impact Scale Survey
Description
Disease specific self-report questionnaire that evaluates disability and health related quality of life post stroke.
Time Frame
12 weeks
Title
Resting State Electroencephalography
Description
EEG assessment
Time Frame
Baseline
Title
Resting State Electroencephalography
Description
EEG assessment
Time Frame
4 weeks
Title
Resting State Electroencephalography
Description
EEG assessment
Time Frame
8 weeks
Title
Resting State Electroencephalography
Description
EEG assessment
Time Frame
12 weeks
Title
Kinematic Assessment of Performance on finger to nose test
Description
Assessment to measure of dysmetria
Time Frame
Baseline
Title
Kinematic Assessment of Performance on finger to nose test
Description
Assessment to measure of dysmetria
Time Frame
4 weeks
Title
Kinematic Assessment of Performance on finger to nose test
Description
Assessment to measure of dysmetria
Time Frame
8 weeks
Title
Kinematic Assessment of Performance on finger to nose test
Description
Assessment to measure of dysmetria
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Post stroke rehabilitation Exclusion Criteria: Not experienced sub-arachnoid bleeding within the last 4 weeks, fractures or trauma to the skull, pregnancy, or progressive RA.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Sullivan, DC, PhD
Organizational Affiliation
Life Univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Life University Center for Chiropractic Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Stroke Patients Receiving Chiropractic Care Post-rehabilitation

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