Ischemic StrokeLAMTSNCT01806233
Lu's Acupuncture and Moxibustion Treatment on Stroke
A study testing Acupuncture and Rehabilitation in people with Ischemic Stroke and Paralysis, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
There will be successive changes in traditional Chinese medicine rehabilitation for stroke patients with limb hemiparetic through therapy of acupuncture and moxibustion. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Ischemic Stroke, Paralysis
- What is being tested?
- Acupuncture and Rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Dec 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The ages of stroke patients from 40 years old to 70 years old.
- The principle diagnosis according to <diagnosis-treatment criteria of stroke(trial implementation)>formulated by Collaboration Acute Brain Diseases of State Administration of Traditional Chinese Medicine in 1996；Ischemic stroke confirmed by CT brain or MRI brain,with stable medical condition and awareness clear.
- Recent stroke from 7 days to 6 months after onset.
- Stroke with limb movement disorder and hypomyotonia，NIHSS≤10，ASHWORTH≤1，GCS>8.
- Written informed consent by inpatient.
Who cannot join
- Stroke with conscious disturbance or serious cognitive impairment.
- Stroke with limb spasm；ASHWORTH≥1.
- Having cardiac pacemaker，metallic foreign body in treatment position，or hemorrhagic tendency.
- Being oversensitive to electrical stimulus.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Longhua Hospital,Shanghai University of Traditional Chinese Medicine
Shanghai, 200032
Qinhui Fu, MD, +86-21-64385700 ext. 3534, ff777315@163.com
Jun Wang, MD
About this study
Official title: Lu' Acupuncture and Moxibustion Treatment on Ischemic Stroke
There will be successive changes in traditional Chinese medicine rehabilitation for stroke patients with limb hemiparetic through therapy of acupuncture and moxibustion.
Read the detailed description
There will be difference in stroke outcomes of ischemic stroke patients with limb hemiparetic from acute to chronic phase under Lu' acupuncture and moxibustion.
- Conditions
- Ischemic Stroke, Paralysis
- Being tested
- Acupuncture, Rehabilitation
- Medical subject headings
- Ischemic Stroke, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
The treatment group：60 patients receive Acupuncture ，selecting acupoint on:Shenting（DU24), Baihui（DU20）, Fengchi（GB20), Hanyan（GB4）, Jianyu（LI15）, Quchi（LI11）,Waiguan（SJ5）, Zusanli（ST36）, Fenglong（ST40）, Xingjian(LV2), Yongquan（KI1）, 20minutes each time，ten times / treatment course，two treatment courses in total.
RehabilitationProcedure or surgery
Also called Rehabilitation treatment
The matched group：60 patients receive rehabilitation treatment，45 minutes each once，ten time as a period of treatment，two periods of treatment in all.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | acupuncture Receives: Procedure: Acupuncture |
| Rehabilitation | Experimental | rehabilitation exercise Receives: Procedure: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simplified Fugl-Meyer Scale
5 times a week, last 4 weeks,assessment on 4 weeks and 8 weeks
Measured: 8 weeks
Secondary outcomes (2)
Burden of Stroke Scale-Boss
5 times a week, last 4 weeks,assessment on 8 weeks and 6 months
Measured: 6 months
Modified Barthel Index
5 times a week, last 4 weeks,assessment on 8 weeks and 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
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 Ischemic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University
- Responsible party
- Sponsor
- Investigators
- Jian Pei, MD, Study chair, Shanghai University of Traditional Chinese MedicineYi Wu, MD, Study chair, Huashan HospitalJie Jia, MD, Study director, Huashan HospitalYi Song, MM, Study director, Shanghai University of Traditional Chinese MedicineZouqin Huang, MM, Principal investigator, Shanghai University of Traditional Chinese MedicineXiaoxin You, MM, Principal investigator, Shanghai University of Traditional Chinese MedicineQinhui FU, MD, Principal investigator, Shanghai University of Traditional Chinese MedicineJun Wang, MM, Principal investigator, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806233
- Sponsor's protocol ID
- 3534123123
- Acronym
- LAMTS
- Status last verified
- Aug 2021
- First submitted
- 26 Feb 2013
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Xu J, Pei J, Fu QH, Zhan YJ. The Prognostic Value of Traditional Chinese Medicine Symptoms in Acute Ischemic Stroke: A Pilot Study. Evid Based Complement Alternat Med. 2020 Jul 15;2020:1520851. doi: 10.1155/2020/1520851. eCollection 2020.
PubMed 32733577
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lu' Acupuncture and Moxibustion Treatment on Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01806233
- Acronym / sponsor ID
- LAMTS / 3534123123
- Conditions
- Ischemic Stroke, Paralysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Fudan University
- Study start
- Mar 2013
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 7 Mar 2013 (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.
There will be successive changes in traditional Chinese medicine rehabilitation for stroke patients with limb hemiparetic through therapy of acupuncture and moxibustion.
Detailed description
There will be difference in stroke outcomes of ischemic stroke patients with limb hemiparetic from acute to chronic phase under Lu' acupuncture and moxibustion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: Acupunctureacupuncture |
| Rehabilitation | Experimental | Procedure: Rehabilitationrehabilitation exercise |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The ages of stroke patients from 40 years old to 70 years old.
- The principle diagnosis according to <diagnosis-treatment criteria of stroke(trial implementation)>formulated by Collaboration Acute Brain Diseases of State Administration of Traditional Chinese Medicine in 1996；Ischemic stroke confirmed by CT brain or MRI brain,with stable medical condition and awareness clear.
- Recent stroke from 7 days to 6 months after onset.
- Stroke with limb movement disorder and hypomyotonia，NIHSS≤10，ASHWORTH≤1，GCS>8.
- Written informed consent by inpatient.
Key exclusion criteria (4 listed)
- Stroke with conscious disturbance or serious cognitive impairment.
- Stroke with limb spasm；ASHWORTH≥1.
- Having cardiac pacemaker，metallic foreign body in treatment position，or hemorrhagic tendency.
- Being oversensitive to electrical stimulus.
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 |
|---|---|---|
| AcupunctureThe treatment group：60 patients receive Acupuncture ，selecting acupoint on:Shenting（DU24), Baihui（DU20）, Fengchi（GB20), Hanyan（GB4）, Jianyu（LI15）, Quchi（LI11）,Waiguan（SJ5）, Zusanli（ST36）, Fenglong（ST40）, Xingjian(LV2), Yongquan（KI1）, 20minutes each time，ten times / treatment course，two treatment courses in total. | Procedure or surgery | Acupuncture |
| RehabilitationAlso: Rehabilitation treatmentThe matched group：60 patients receive rehabilitation treatment，45 minutes each once，ten time as a period of treatment，two periods of treatment in all. | Procedure or surgery | Rehabilitation |
Primary outcome
Simplified Fugl-Meyer Scale
Time frame: 8 weeks
5 times a week, last 4 weeks,assessment on 4 weeks and 8 weeks
2 secondary outcomes
Burden of Stroke Scale-Boss
Time frame: 6 months
Modified Barthel Index
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Derived from this study: PubMed 32733577Xu J, Pei J, Fu QH, Zhan YJ. The Prognostic Value of Traditional Chinese Medicine Symptoms in Acute Ischemic Stroke: A Pilot Study. Evid Based Complement Alternat Med. 2020 Jul 15;2020:1520851. doi: 10.1155/2020/1520851. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
Jian Pei, MD study chair
Shanghai University of Traditional Chinese Medicine
Yi Wu, MD study chair
Huashan Hospital
Jie Jia, MD study director
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Rehabilitation in people with Ischemic Stroke and Paralysis, run by Shanghai University of Traditional Chinese Medicine 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?
The sponsor lists 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Aug 2021. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Pei, MD (021-64385700 ext. 3534, jianpei99@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simplified Fugl-Meyer Scale (time frame: 8 weeks). 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 NCT01806233, 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 11 Aug 2021.