StrokePhase 1/2NCT01037894
Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?
A Phase 1/2 study testing Acupuncture and Conventional rehabilitation in people with Stroke, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
The purpose is to establish whether acupuncture in addition to conventional rehabilitation programme can improve the functional outcome and quality of life of surgical patients with haemorrhagic stroke, as compared to conventional rehabilitation programme alone. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Acupuncture and Conventional rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Sep 2012
- Phase
- Phase 1/2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Patient inclusion Criteria:
- Patients after acute hemorrhagic stroke;
- Within the first month after acute presentation;
- Premorbid mobility level: Independent Indoor or Outdoor Walker;
- Co-operative and willing to comply with the rehabilitation program;
Patient exclusion Criteria:
- Cardiac Pacemaker;
- Patient who is apprehensive to acupuncture;
- Clotting abnormality;
- Poor local skin conditions.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose is to establish whether acupuncture in addition to conventional rehabilitation programme can improve the functional outcome and quality of life of surgical patients with haemorrhagic stroke, as compared to conventional rehabilitation programme alone.
Read the detailed description
The investigators aim to recruit 60 patients over a 30 month period. Each patient will have six week of acupuncture treatment (either early within the first six week, or delayed after the first six week of observation and assessment of primary outcome).
Primary outcome measures:
Clinical outcome at the end of week 6 acupuncture treatment: Glasgow Outcome Score extended.
Secondary outcome measures:
Modified Rankin Score, Functional Independence Measure (FIM) score, Modified Aschoff Score, Neurocognitive State Examination (NCSE) score, Barthel index, Modified Rivermead Mobility Index (MRMI), Modified Functional Ambulation Category (MFAC) and motor scores of upper limb and lower limb with Fugl-Meyer Scale at the end of week six acupuncture treatment.
- Conditions
- Stroke
- Being tested
- Acupuncture, Conventional rehabilitation
- Keywords
- Acupuncture,Intracerebral hemorrhage, Stroke
- Medical subject headings
- Stroke, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Acupuncture from physiotherapist (with accredited training in acupuncture) in Shatin Hospital, three sessions per week for six weeks, and each session 30 minutes.
Conventional rehabilitationProcedure or surgery
In-patient physiotherapy, occupational therapy and speech therapy.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Acupuncture and conventional rehabilitation Receives: Procedure: Acupuncture |
| Control | Active comparator | Conventional rehabilitation only Receives: Procedure: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Outcome Scale Extended
Measured: Six week
Secondary outcomes (8)
Functional Independence Measure (FIM) score
Measured: Six week
Modified Aschoff Score
Measured: Six week
Neurocognitive State Examination(NCSE)score
Measured: Six week
Motor scores of upper limb and lower limb with Fugl-Meyer Scale
Measured: six week
Modified Functional Ambulation Category (MFAC)
Measured: Six week
Modified Rivermead Mobility Index (MRMI)
Measured: Six week
Barthel Index
Measured: Six week
Modified Rankin Scale
Measured: Six week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2012
- Study completionSep 2012
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.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George KC Wong, Chinese University of Hong Kong
- Investigators
- George KC Wong, Principal investigator, Division of Neurosurgery, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037894
- Sponsor's protocol ID
- GW003
- Status last verified
- Jan 2013
- First submitted
- 22 Dec 2009
- Last updated
- 14 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?
- ClinicalTrials.gov ID
- NCT01037894
- Acronym / sponsor ID
- GW003
- Conditions
- Stroke
- Keywords
- Acupuncture,Intracerebral hemorrhage, Stroke
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 23 Dec 2009 (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 purpose is to establish whether acupuncture in addition to conventional rehabilitation programme can improve the functional outcome and quality of life of surgical patients with haemorrhagic stroke, as compared to conventional rehabilitation programme alone.
Detailed description
The investigators aim to recruit 60 patients over a 30 month period. Each patient will have six week of acupuncture treatment (either early within the first six week, or delayed after the first six week of observation and assessment of primary outcome).
Primary outcome measures:
Clinical outcome at the end of week 6 acupuncture treatment: Glasgow Outcome Score extended.
Secondary outcome measures:
Modified Rankin Score, Functional Independence Measure (FIM) score, Modified Aschoff Score, Neurocognitive State Examination (NCSE) score, Barthel index, Modified Rivermead Mobility Index (MRMI), Modified Functional Ambulation Category (MFAC) and motor scores of upper limb and lower limb with Fugl-Meyer Scale at the end of week six acupuncture treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: AcupunctureAcupuncture and conventional rehabilitation |
| Control | Active comparator | Procedure: Conventional rehabilitationConventional rehabilitation only |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| AcupunctureAcupuncture from physiotherapist (with accredited training in acupuncture) in Shatin Hospital, three sessions per week for six weeks, and each session 30 minutes. | Procedure or surgery | Acupuncture |
| Conventional rehabilitationIn-patient physiotherapy, occupational therapy and speech therapy. | Procedure or surgery | Control |
Primary outcome
Glasgow Outcome Scale Extended
Time frame: Six week
8 secondary outcomes
Functional Independence Measure (FIM) score
Time frame: Six week
Modified Aschoff Score
Time frame: Six week
Neurocognitive State Examination(NCSE)score
Time frame: Six week
Motor scores of upper limb and lower limb with Fugl-Meyer Scale
Time frame: six week
Modified Functional Ambulation Category (MFAC)
Time frame: Six week
Modified Rivermead Mobility Index (MRMI)
Time frame: Six week
Barthel Index
Time frame: Six week
Modified Rankin Scale
Time frame: Six week
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 14 Jan 2013.
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
George KC Wong principal investigator
Division of Neurosurgery, CUHK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Acupuncture and Conventional rehabilitation in people with Stroke, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 14 Jan 2013. 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 China. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Glasgow Outcome Scale Extended (time frame: Six week). 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 14 Jan 2013.