Acute StrokeNCT02210988
Evaluating the Therapeutic Effect of Acupuncture on Acute Ischemic Stroke Patients
A study testing acupuncture in people with Acute Stroke, run by Cathay General Hospital.
Trial summary
The investigators design a randomized, single blinded, control study to evaluate the therapeutic effect of acupuncture in acute ischemic stroke patients: Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- May 2011to May 2012
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- newly onset of acute ischemic stroke,Exclusion Criteria:
- without underling systemic major illness
Who cannot join
None listed.
About this study
The investigators design a randomized, single blinded, control study to evaluate the therapeutic effect of acupuncture in acute ischemic stroke patients:
Read the detailed description
Acupuncture therapy in traditional Chinese medicine has been verified in many disease by thousands years. Due to the feasible and relatively safe in acupuncture management, now the west countries had been well document about acupuncture in medicine. The acupuncture therapy applied in post stroke functional recovery has been considered as more benefit than physical therapy only to post stroke rehabilitation. However, the effect of combined acupuncture therapy with standard management in acute stroke patient still remains unknown. The aim of this study is to evaluate the therapeutic effect of acupuncture in acute ischemic stroke patients. The prospective study was designed as a randomized, single blinded, control trial. We collected newly onset of acute ischemic stroke patient without underling systemic major illness, and randomized assign the collected patients into two groups as experimental (acupuncture)group and normal control group. The two groups both treat with routine western medicine as standard stroke therapy. The outcome measurement will evaluate by the changes from baseline at one and three months. The assessed scales including NIH stroke scale, the Barthel index, the Functional Independence Measure score, the Fugl-Meyer Assessment, and the Modified Rankin Scale. We compared the all variable measurements to see if any benefit from acupuncture group than the control group.
- Conditions
- Acute Stroke
- Being tested
- acupuncture
- Keywords
- Acupuncture therap, Acute stroke, Randomized controlled trials
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
Intervention with acupuncture
| Study group | Role | What they receive |
|---|---|---|
| acupuncture | Experimental | The acupuncture treatment for the intervention group was provided once daily for 2 weeks. Receives: Other: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Institute of Health Stroke Scale
Measured: the fourth week
Fugal-Mayer Assessment
Measured: The fourth week
Functional Independent Measure
Measured: The fourth week
Secondary outcomes (3)
National Institute of Health Stroke Scale
Measured: The three months after admission
Barthel index
Measured: The three month after admission
Modified Rankin Scale
Measured: The three after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startMay 2011
- Primary completionMar 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cathay General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210988
- Sponsor's protocol ID
- CGHIRBCT-P-100002
- Status last verified
- Aug 2014
- First submitted
- 14 Jul 2014
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu CH, Hsieh YT, Tseng HP, Lin HC, Lin CL, Wu TY, Lin SH, Tsao SH, Zhang H. Acupuncture for a first episode of acute ischaemic stroke: an observer-blinded randomised controlled pilot study. Acupunct Med. 2016 Oct;34(5):349-355. doi: 10.1136/acupmed-2015-010825. Epub 2016 Apr 19.
PubMed 27095698
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Therapeutic Effect of Acupuncture on Acute Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT02210988
- Acronym / sponsor ID
- CGHIRBCT-P-100002
- Conditions
- Acute Stroke
- Keywords
- Acupuncture therap, Acute stroke, Randomized controlled trials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Cathay General HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 7 Aug 2014 (estimated)
- 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 investigators design a randomized, single blinded, control study to evaluate the therapeutic effect of acupuncture in acute ischemic stroke patients:
Detailed description
Acupuncture therapy in traditional Chinese medicine has been verified in many disease by thousands years. Due to the feasible and relatively safe in acupuncture management, now the west countries had been well document about acupuncture in medicine. The acupuncture therapy applied in post stroke functional recovery has been considered as more benefit than physical therapy only to post stroke rehabilitation. However, the effect of combined acupuncture therapy with standard management in acute stroke patient still remains unknown. The aim of this study is to evaluate the therapeutic effect of acupuncture in acute ischemic stroke patients. The prospective study was designed as a randomized, single blinded, control trial. We collected newly onset of acute ischemic stroke patient without underling systemic major illness, and randomized assign the collected patients into two groups as experimental (acupuncture)group and normal control group. The two groups both treat with routine western medicine as standard stroke therapy. The outcome measurement will evaluate by the changes from baseline at one and three months. The assessed scales including NIH stroke scale, the Barthel index, the Functional Independence Measure score, the Fugl-Meyer Assessment, and the Modified Rankin Scale. We compared the all variable measurements to see if any benefit from acupuncture group than the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acupuncture | Experimental | Other: acupunctureThe acupuncture treatment for the intervention group was provided once daily for 2 weeks. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- newly onset of acute ischemic stroke,Exclusion Criteria:
- without underling systemic major illness
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| acupunctureIntervention with acupuncture | Other | acupuncture |
Primary outcome
National Institute of Health Stroke Scale
Time frame: the fourth week
Fugal-Mayer Assessment
Time frame: The fourth week
Functional Independent Measure
Time frame: The fourth week
3 secondary outcomes
National Institute of Health Stroke Scale
Time frame: The three months after admission
Barthel index
Time frame: The three month after admission
Modified Rankin Scale
Time frame: The three after admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 27095698Liu CH, Hsieh YT, Tseng HP, Lin HC, Lin CL, Wu TY, Lin SH, Tsao SH, Zhang H. Acupuncture for a first episode of acute ischaemic stroke: an observer-blinded randomised controlled pilot study. Acupunct Med. 2016 Oct;34(5):349-355. doi: 10.1136/acupmed-2015-010825. Epub 2016 Apr 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Acute Stroke, run by Cathay General Hospital.
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 2 inclusion and 0 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: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
National Institute of Health Stroke Scale (time frame: the fourth week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02210988, which also lists 1 linked publication.
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 8 Feb 2023.