StrokeNCT05027178
Stroke Patients Receiving Chiropractic Care Post-rehabilitation
A study testing Chiropractic Care in people with Stroke, run by Life University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Chiropractic Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2020to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Post stroke rehabilitation
Who cannot join
- Not experienced sub-arachnoid bleeding within the last 4 weeks, fractures or trauma to the skull, pregnancy, or progressive RA.
Trial locations and contacts
1 site in 1 country.
United States1 site
Life University Center for Chiropractic Research
Atlanta, Georgia, 30308
About this study
Official title: 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.
- Conditions
- Stroke
- Being tested
- Chiropractic Care
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic CareOther
Chiropractic care on stroke participants
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Chiropractic Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke Impact Scale Survey
Disease specific self-report questionnaire that evaluates disability and health related quality of life post stroke.
Measured: Baseline
Stroke Impact Scale Survey
Disease specific self-report questionnaire that evaluates disability and health related quality of life post stroke.
Measured: 4 weeks
Stroke Impact Scale Survey
Disease specific self-report questionnaire that evaluates disability and health related quality of life post stroke.
Measured: 8 weeks
Stroke Impact Scale Survey
Disease specific self-report questionnaire that evaluates disability and health related quality of life post stroke.
Measured: 12 weeks
Resting State Electroencephalography
EEG assessment
Measured: Baseline
Resting State Electroencephalography
EEG assessment
Measured: 4 weeks
Resting State Electroencephalography
EEG assessment
Measured: 8 weeks
Resting State Electroencephalography
EEG assessment
Measured: 12 weeks
Kinematic Assessment of Performance on finger to nose test
Assessment to measure of dysmetria
Measured: Baseline
Kinematic Assessment of Performance on finger to nose test
Assessment to measure of dysmetria
Measured: 4 weeks
Kinematic Assessment of Performance on finger to nose test
Assessment to measure of dysmetria
Measured: 8 weeks
Kinematic Assessment of Performance on finger to nose test
Assessment to measure of dysmetria
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start7 Aug 2020
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Why it stopped: The study is being reformatted and will have a different protocol for the relaunch.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Life University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Sullivan, DC, PhD, Principal investigator, Life Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027178
- Sponsor's protocol ID
- I-0014
- Status last verified
- Feb 2023
- First submitted
- 27 Aug 2021
- Last updated
- 17 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic Comparison of Ischemic and Hemorrhagic Stroke Patients Receiving Chiropractic Care Post-rehabilitation
- ClinicalTrials.gov ID
- NCT05027178
- Acronym / sponsor ID
- I-0014
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study is being reformatted and will have a different protocol for the relaunch.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Life UniversityUniversity, hospital or other
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chiropractic care for Ischemic Stroke Patients | Experimental | Other: Chiropractic Care12 weeks of full spine chiropractic care will be provided to patient. Patients may be asked to present one- two times per week. |
| Chiropractic care for Hemorrhagic Stroke Patients | Experimental | Other: Chiropractic Care12 weeks of full spine chiropractic care will be provided to patient. Patients may be asked to present one- two times per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Post stroke rehabilitation
Key exclusion criteria (1 listed)
- Not experienced sub-arachnoid bleeding within the last 4 weeks, fractures or trauma to the skull, pregnancy, or progressive RA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chiropractic CareChiropractic care on stroke participants | Other | Chiropractic care for Hemorrhagic Stroke Patients, Chiropractic care for Ischemic Stroke Patients |
Primary outcome
Stroke Impact Scale Survey
Time frame: Baseline
Disease specific self-report questionnaire that evaluates disability and health related quality of life post stroke.
Stroke Impact Scale Survey
Time frame: 4 weeks
Disease specific self-report questionnaire that evaluates disability and health related quality of life post stroke.
Stroke Impact Scale Survey
Time frame: 8 weeks
Disease specific self-report questionnaire that evaluates disability and health related quality of life post stroke.
Stroke Impact Scale Survey
Time frame: 12 weeks
Disease specific self-report questionnaire that evaluates disability and health related quality of life post stroke.
Resting State Electroencephalography
Time frame: Baseline
EEG assessment
Resting State Electroencephalography
Time frame: 4 weeks
EEG assessment
Resting State Electroencephalography
Time frame: 8 weeks
EEG assessment
Resting State Electroencephalography
Time frame: 12 weeks
EEG assessment
Kinematic Assessment of Performance on finger to nose test
Time frame: Baseline
Assessment to measure of dysmetria
Kinematic Assessment of Performance on finger to nose test
Time frame: 4 weeks
Assessment to measure of dysmetria
Kinematic Assessment of Performance on finger to nose test
Time frame: 8 weeks
Assessment to measure of dysmetria
Kinematic Assessment of Performance on finger to nose test
Time frame: 12 weeks
Assessment to measure of dysmetria
Results and safety
The study was stopped early (reason given: The study is being reformatted and will have a different protocol for the relaunch.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Stroke
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke
Stroke
Recruiting
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Acute Ischemic Stroke, Acute Haemorrhagic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Sullivan, DC, PhD principal investigator
Life Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic Care in people with Stroke, run by Life University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study is being reformatted and will have a different protocol for the relaunch.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke Impact Scale Survey (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.