Stroke Patients Receiving Chiropractic Care Post-rehabilitation

Phenotypic Comparison of Ischemic and Hemorrhagic Stroke Patients Receiving Chiropractic Care Post-rehabilitation

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.

Study Overview

• Status: Terminated
• Conditions: Stroke
• Intervention / Treatment: Other: Chiropractic Care

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Life University Center for Chiropractic Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chiropractic care for Ischemic Stroke Patients; 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 on stroke participants
Experimental: Chiropractic care for Hemorrhagic Stroke Patients; 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 on stroke participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Life University
• Investigators: Principal Investigator: Stephanie Sullivan, DC, PhD, Life Univeristy

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2020
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: I-0014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No