StrokeNCT03054974
TCM Clinical Practice Rehabilitation of Post-stroke Spasticity
A study testing Modern rehabilitation treatment, Modern rehabilitation &TCM and modern rehabilitation &Baimai Ruangao in people with Stroke, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The purpose of this study is to determine the effectiveness,safety and Input-output ratio of chinese traditional treatment in spasm after stroke,both in massage and herbal medicine bathing. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Modern rehabilitation treatment, Modern rehabilitation &TCM and modern rehabilitation &Baimai Ruangao
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,208 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Dec 2018
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- According to the diagnostic criteria of stroke and diagnosed by CT or MRI
- Patient must be between the ages of 18 and 85 years.
- All patients were examined at least 1 month after stroke and less than 12 months.
- At least a set of spasmous muscles' level ≥1+ of dysfunctional extremities (modified Ashworth scale)
- Body movement function decreased significantly.
- The doses and kinds of anticonvulsant drugs should be used stable for more than 1 month if they are used
- Patient must understand and be willing, able and likely to comply with all study procedures.
- Patient must be able to give voluntary written informed consent.
Who cannot join
- Significant cognitive defects(MMSE<16)，unable to finish the Fugl-Meyer scale,etc..
- Other significant limb diseases such as fracture, severe arthritis,amputation
- Joint contracture formation
- Patients with significant pain and swelling suffering from complex regional syndrome after acute stroke
- Accept botulinum toxin or alcohol nerve block 3 months prior to the start of the experiment
- Patients need nerve block at any point of time during the whole experiment procedure.
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- Serious cardiac,hepatic or renal insufficiency and patients with shock.
- Limb skin of patients who need medicated is visible wound.
- Patients with cancer or pregnancy
- Patients who participate in other clinical studies within 6 months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Li jianan, Doctor, +862583318752, lijianan@carm.org.cn
Li jianan, Doctor
About this study
Official title: Traditional Chinese Medicine Clinical Practice Rehabilitation of Post-stroke Spasticity
The purpose of this study is to determine the effectiveness,safety and Input-output ratio of chinese traditional treatment in spasm after stroke,both in massage and herbal medicine bathing.
Read the detailed description
A Muti-center randomized controlled study with large samples to observe improvement of motor function,severity of spasm,ADL(activity of daily lives),by standardized protocols of TCM techniques(massage and herbal bathing) combined with conventional rehabilitation on spasm after stroke in 1 month.Modified Ashworth scale,Fugl-Meyer Index and Modified barthel Index were used for spasm,motor function and ADL.And also the follow up research within 3 months and 6 months focus on the efficacy duration of TCM on spasm.Try to find suitable timing for intervention on spasm by CTM(Massage and herbal medicine bathing)and the connection between spasm severity and treatment efficacy.
- Conditions
- Stroke
- Being tested
- Modern rehabilitation treatment, Modern rehabilitation &TCM, modern rehabilitation &Baimai Ruangao, modern rehabilitation &Tibetan medicine
- Keywords
- Stroke, Traditional Chinese Medicine, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modern rehabilitation treatmentOther
PT 1 hour per day and OT 30min per day
Modern rehabilitation &TCMOther
Traditional Chinese Medicine, including massage and medicated bath
modern rehabilitation &Baimai RuangaoOther
modern rehabilitation treatment with Baimai Ruangao and massage
modern rehabilitation &Tibetan medicineOther
modern rehabilitation treatment and Tibetan medicine(medicated bath with wuweiganlu and rub with baimairuangao)
| Study group | Role | What they receive |
|---|---|---|
| Modern rehabilitation treatment | Experimental | Modern rehabilitation treatment Receives: Other: Modern rehabilitation treatment |
| Modern rehabilitation &TCM | Experimental | Modern rehabilitation treatment and traditional Chinese medicine Receives: Other: Modern rehabilitation &TCM |
| modern rehabilitation &Baimai Ruangao | Experimental | modern rehabilitation treatment and Baimai Ruangao Receives: Other: modern rehabilitation &Baimai Ruangao |
| modern rehabilitation &Tibetan medicine | Experimental | modern rehabilitation treatment and Tibetan medicine treatment Receives: Other: modern rehabilitation &Tibetan medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale
the common used clinical measurement to assess the levels of limb spasticity
Measured: 6 months
Secondary outcomes (1)
Fugl-Meyer Moter Assessment
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 posted16 Feb 2017
- Study startJan 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
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 The First Affiliated Hospital with Nanjing Medical UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,208 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JiangFeng, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Li jianan, Doctor, Study chair, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054974
- Sponsor's protocol ID
- 2013BAI10B04
- Status last verified
- Feb 2017
- First submitted
- 20 Nov 2016
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Chinese Medicine Clinical Practice Rehabilitation of Post-stroke Spasticity
- ClinicalTrials.gov ID
- NCT03054974
- Acronym / sponsor ID
- 2013BAI10B04
- Conditions
- Stroke
- Keywords
- Stroke, Traditional Chinese Medicine, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,208 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 16 Feb 2017 (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 purpose of this study is to determine the effectiveness,safety and Input-output ratio of chinese traditional treatment in spasm after stroke,both in massage and herbal medicine bathing.
Detailed description
A Muti-center randomized controlled study with large samples to observe improvement of motor function,severity of spasm,ADL(activity of daily lives),by standardized protocols of TCM techniques(massage and herbal bathing) combined with conventional rehabilitation on spasm after stroke in 1 month.Modified Ashworth scale,Fugl-Meyer Index and Modified barthel Index were used for spasm,motor function and ADL.And also the follow up research within 3 months and 6 months focus on the efficacy duration of TCM on spasm.Try to find suitable timing for intervention on spasm by CTM(Massage and herbal medicine bathing)and the connection between spasm severity and treatment efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Modern rehabilitation treatment | Experimental | Other: Modern rehabilitation treatmentModern rehabilitation treatment |
| Modern rehabilitation &TCM | Experimental | Other: Modern rehabilitation &TCMModern rehabilitation treatment and traditional Chinese medicine |
| modern rehabilitation &Baimai Ruangao | Experimental | Other: modern rehabilitation &Baimai Ruangaomodern rehabilitation treatment and Baimai Ruangao |
| modern rehabilitation &Tibetan medicine | Experimental | Other: modern rehabilitation &Tibetan medicinemodern rehabilitation treatment and Tibetan medicine treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- According to the diagnostic criteria of stroke and diagnosed by CT or MRI
- Patient must be between the ages of 18 and 85 years.
- All patients were examined at least 1 month after stroke and less than 12 months.
- At least a set of spasmous muscles' level ≥1+ of dysfunctional extremities (modified Ashworth scale)
- Body movement function decreased significantly.
Key exclusion criteria (10 listed)
- Significant cognitive defects(MMSE<16)，unable to finish the Fugl-Meyer scale,etc..
- Other significant limb diseases such as fracture, severe arthritis,amputation
- Joint contracture formation
- Patients with significant pain and swelling suffering from complex regional syndrome after acute stroke
- Accept botulinum toxin or alcohol nerve block 3 months prior to the start of the experiment
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 |
|---|---|---|
| Modern rehabilitation treatmentPT 1 hour per day and OT 30min per day | Other | Modern rehabilitation treatment |
| Modern rehabilitation &TCMTraditional Chinese Medicine, including massage and medicated bath | Other | Modern rehabilitation &TCM |
| modern rehabilitation &Baimai Ruangaomodern rehabilitation treatment with Baimai Ruangao and massage | Other | modern rehabilitation &Baimai Ruangao |
| modern rehabilitation &Tibetan medicinemodern rehabilitation treatment and Tibetan medicine(medicated bath with wuweiganlu and rub with baimairuangao) | Other | modern rehabilitation &Tibetan medicine |
Primary outcome
Modified Ashworth Scale
Time frame: 6 months
the common used clinical measurement to assess the levels of limb spasticity
1 secondary outcome
Fugl-Meyer Moter Assessment
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 16 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
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.
Li jianan, Doctor study chair
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modern rehabilitation treatment, Modern rehabilitation &TCM and modern rehabilitation &Baimai Ruangao in people with Stroke, run by The First Affiliated Hospital with Nanjing Medical University 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 8 inclusion and 10 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 16 Feb 2017. 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 li jianan, Doctor (+862583318752, lijianan@carm.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (time frame: 6 months). 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 16 Feb 2017.