Stroke Patients Receiving Chiropractic Care Post-rehabilitation

Sponsor
Life University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05027178
Collaborator
(none)
30
1
2
34.8
0.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Chiropractic Care
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Data analysis - single blinded
Primary Purpose:
Supportive Care
Official Title:
Phenotypic Comparison of Ischemic and Hemorrhagic Stroke Patients Receiving Chiropractic Care Post-rehabilitation
Actual Study Start Date :
Aug 7, 2020
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Stroke Impact Scale Survey [Baseline]

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

  2. Stroke Impact Scale Survey [4 weeks]

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

  3. Stroke Impact Scale Survey [8 weeks]

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

  4. Stroke Impact Scale Survey [12 weeks]

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

  5. Resting State Electroencephalography [Baseline]

    EEG assessment

  6. Resting State Electroencephalography [4 weeks]

    EEG assessment

  7. Resting State Electroencephalography [8 weeks]

    EEG assessment

  8. Resting State Electroencephalography [12 weeks]

    EEG assessment

  9. Kinematic Assessment of Performance on finger to nose test [Baseline]

    Assessment to measure of dysmetria

  10. Kinematic Assessment of Performance on finger to nose test [4 weeks]

    Assessment to measure of dysmetria

  11. Kinematic Assessment of Performance on finger to nose test [8 weeks]

    Assessment to measure of dysmetria

  12. Kinematic Assessment of Performance on finger to nose test [12 weeks]

    Assessment to measure of dysmetria

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Life University Center for Chiropractic Research Atlanta Georgia United States 30308

Sponsors and Collaborators

  • Life University

Investigators

  • Principal Investigator: Stephanie Sullivan, DC, PhD, Life Univeristy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Life University
ClinicalTrials.gov Identifier:
NCT05027178
Other Study ID Numbers:
  • I-0014
First Posted:
Aug 30, 2021
Last Update Posted:
Sep 22, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 22, 2021