Post-strokeIRTPANCT05147077
Integrated Rehabilitation in Treating Post-stroke Anxiety
A study testing Acupuncture in people with Post-stroke and Anxiety, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial summary
Post-stroke anxiety (PSA) is a common complication of stroke that leads to dysfunction and reduces the quality of life. PSA exacerbates cognitive dysfunction, delays the recovery process, and increases the disability, mortality, and recurrence rates of stroke. Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Post-stroke, Anxiety
- What is being tested?
- Acupuncture
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteChina
- Study dates
- 24 Jan 2022to 31 Dec 2024
- 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 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria of cerebral infarction or cerebral hemorrhage with anxiety disorder, the type of depression and clinical syndrome of liver stagnation transforming into fire;
- Patients with clear consciousness, stable vital signs, ability to understand and cooperate with instructions, barthel index (BI) > 20, FMA (0-95), Mini-mental State Examination (MMSE) meet the following criteria: illiterate > 17, primary school level > 20, secondary school level (including technical secondary school) > 22, and college level (including junior college) > 23 points;
- 25 <= age <= 85 years, male or female;
- First episode of stroke, no personal or family history of mental disability before the stroke;
- Anxiety level as mild or moderate (HAMA scores >= 7 and <= 21);
- Anxiety symptoms occur after the stroke in a clear temporal sequence;
- The course of the PSA is limited to 2 weeks to 36 months after the stroke;
- Participants can understand the study protocol and written informed consent is signed.
Who cannot join
- Patients with acute brain trauma, brain infection, effusion, or tumor occupation;
- There are intracranial metals and other foreign bodies (such as orthopedic materials, arterial clips, etc.), cardiac pacemakers, deep brain stimulators and other electronic devices;
- Previous seizures, including primary and secondary seizures；
- Patients have severe complications in cardiovascular, liver, kidney or psychiatric history;
- There is a significant cognitive impairment (MMSE: literacy <= 17, primary school level <= 20, secondary school level (including technical secondary school) <= 22, and college level (including junior college) <= 23 points) or hearing impairment, aphasia;
- Coma, dying or chronic illness;
- Patients have taken psychotropic drugs or been treated for anxiety for nearly a month;
- People with unstable vital signs or patients with other mental disorders.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310000
Hantong Hu, 18667103032 ext. 86, 413351308@qq.com
About this study
Official title: Integrated Rehabilitation in Treating Post-stroke Anxiety: Study Protocol for a Multicentre, Prospective, Randomised, Controlled Trial
Post-stroke anxiety (PSA) is a common complication of stroke that leads to dysfunction and reduces the quality of life. PSA exacerbates cognitive dysfunction, delays the recovery process, and increases the disability, mortality, and recurrence rates of stroke. Therefore, early clinical treatments for PSA are important to improve the prognosis and restore the social functions of stroke patients.
Integrated rehabilitation has significant advantages in the treatment of PSA. First of all, there is a wide range of rehabilitation methods, such as acupuncture, traditional Chinese medicine, and repetitive transcranial magnetic stimulation, which have been proved to be effective for PSA. However, as the application of integrated rehabilitation becomes more and more widespread, its shortcomings are gradually emerging. For example, most of the treatment protocols used in clinical studies are based on personal experience of the investigators, a unified protocol has not yet been formed, treatment methods are still insufficient in standardization and reproducibility. More studies focus solely on the improvement of a certain symptom by a certain rehabilitation therapy, but ignore the important theoretical basis of the "holistic concept", thus showing the uneven clinical efficacy. For the above existing problems, it is necessary to conduct original and innovative research.
Read the detailed description
This randomized controlled trial will enroll 188 PSA patients from the Third Affiliated Hospital of Zhejiang Chinese Medical University, Zhejiang General Hospital of Armed Police, Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University, and Jinhua Second Hospital. All patients will be randomly assigned to either the integrated rehabilitation group or the standard care group through a randomization system. The primary outcome will be assessed by hamilton anxiety (HAMA) scale, self-rating anxiety scale (SAS), and activity of daily living (ADL) scale. Secondary outcomes will include montreal cognitive assessment (MoCA) scale, the simple fugl-meyer assessment of motor function (FMA) scale and pittsburgh sleep quality index (PSQI).
- Conditions
- Post-stroke, Anxiety
- Being tested
- Acupuncture
- Keywords
- post-stroke anxiety, integrated rehabilitation, acupuncture, traditional Chinese medicine, repetitive transcranial magnetic stimulation, randomized controlled trial
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Also called Traditional Chinese medicine, Repetitive transcranial magnetic stimulation, Standard care
Acupuncture:
Scalp acupuncture includes middle line of forehead (MS1), a front line by the forehead (MS2), and middle line of vertex (MS5), these acupoints are needled for 1 inch with the direction with scalp tilted 15-30 degrees.
Body acupuncture includes Yintang (DU29), Taichong (LR3), Shenmen (HT7), Neiguan (PC6), Danzhong (RN17), Tongli (HT5), Xingjian (LR2).
Traditional Chinese medicine Danzhixiaoyao Power: Danpi 10g, fried Zhizi 10g, Danggui 12g, Baishao 12g, fried Chaihu 6g, Fuling 10g, fried Baishu 10, roasted Gancao 3g.
Repetitive transcranial magnetic stimulation The CCY-I magnetic field stimulator from Wuhan Irid Medical Equipment New Technology Co is used, with a frequency of 1Hz.
Standard care The same as the standard care group.
| Study group | Role | What they receive |
|---|---|---|
| Integrated rehabilitation group | Experimental | This group will include 94 patients. On the basis of standard care, patients in this group will receive acupuncture, traditional Chinese medicine, repetitive transcranial magnetic stimulation. Receives: Procedure: Acupuncture |
| Standard care group | Active comparator | The patients were recommended to take one oral tablet of escitalopram oxalate (10 mg) every morning after a meal for 4 weeks. Internal medicine includes lipid regulation, blood sugar control, anti-hypertension, anticoagulation, and other drugs. Moreover, general duty nursing and motor therapy are also needed. Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hamilton anxiety (HAMA) scale
The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).
Measured: Baseline, at 4-week during treatment, at 8-week follow-up
Change in self-rating anxiety scale (SAS)
The Zung Self-Rating Anxiety Scale (SAS) is a method of measuring levels of anxiety in patients who have anxiety-related symptoms. The scale focuses on the most common general anxiety disorders; coping with stress typically causes anxiety.
The SAS test is self-administered, with each response using a 4-point scale, from 'none of the time" to "most of the time." There are 20 questions with 15 increasing anxiety level questions and 5 decreasing anxiety questions. There are two formats, self-evaluations and clinical evaluations.
Measured: Baseline, at 4-week during treatment
Change in activity of daily living (ADL) scale
The Activities of Daily Living are a series of basic activities necessary for independent living at home or in the community. They are performed on a daily basis. There are many variations on the definition of the ADLs, but most organizations agree there are 5 basic categories.
Measured: Baseline, at 4-week during treatment, at 8-week follow-up
Secondary outcomes (3)
Change in Montreal cognitive assessment (MoCA) scale
Montreal Cognitive Assessment scoring is based on a 30-point scale, with points awarded differently depending on the type of question asked. For instance, you can earn one point for each animal you identify in a picture, but listing the names of 13 fruits in under a minute gains you only two points.
Measured: Baseline, at 4-week during treatment
Change in the Fugl-meyer assessment of motor function (FMA) scale
Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.
Points are divided among the domains as follows:
Motor score: ranges from 0 (hemiplegia) to 100 points (normal motor performance). Divided into 66 points for upper extremity and 34 points for the lower extremity.
Sensation: ranges from 0 to 24 points. Divided into 8 points for light touch and 16 points for position sense.
Balance: ranges from 0 to 14 points. Divided into 6 points for sitting and 8 points for standing.
Joint range of motion: ranges from 0 to 44 points. Joint pain: ranges from 0 to 44 points.
Measured: Baseline, at 4-week during treatment
Change in Pittsburgh sleep quality index (PSQI)
The range of values for questions 5 through 10 are all 0 to 3. Questions 1 through 9 are not allowed to be missing except as noted below. If these questions are missing then any scores calculated using missing questions are also missing. Thus it is important to make sure that all questions 1 through 9 have been answered.
In the event that a range is given for an answer (for example, '30 to 60' is written as the answer to Q2, minutes to fall asleep), split the difference and enter 45.
Measured: Baseline, at 4-week during treatment, at 8-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start24 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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 Post-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
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Gao, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- Hong Gao, Deputy dean, Principal investigator, Third Affiliated Hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147077
- Sponsor's protocol ID
- 2021ZX010-A
- Acronym
- IRTPA
- Status last verified
- Jun 2022
- First submitted
- 1 Dec 2021
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou J, Fan L, Hu H, Shen K, Wu L, Lin X, Gao H. The Efficacy of Integrated Rehabilitation for Post-Stroke Anxiety: Study Protocol for a Prospective, Multicenter, Randomized Controlled Trial. Int J Gen Med. 2022 Sep 6;15:7101-7111. doi: 10.2147/IJGM.S381434. eCollection 2022.
PubMed 36097565
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Rehabilitation in Treating Post-stroke Anxiety: Study Protocol for a Multicentre, Prospective, Randomised, Controlled Trial
- ClinicalTrials.gov ID
- NCT05147077
- Acronym / sponsor ID
- IRTPA / 2021ZX010-A
- Conditions
- Post-stroke, Anxiety
- Keywords
- post-stroke anxiety, integrated rehabilitation, acupuncture, traditional Chinese medicine, repetitive transcranial magnetic stimulation, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Dec 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.
Post-stroke anxiety (PSA) is a common complication of stroke that leads to dysfunction and reduces the quality of life. PSA exacerbates cognitive dysfunction, delays the recovery process, and increases the disability, mortality, and recurrence rates of stroke. Therefore, early clinical treatments for PSA are important to improve the prognosis and restore the social functions of stroke patients.
Integrated rehabilitation has significant advantages in the treatment of PSA. First of all, there is a wide range of rehabilitation methods, such as acupuncture, traditional Chinese medicine, and repetitive transcranial magnetic stimulation, which have been proved to be effective for PSA. However, as the application of integrated rehabilitation becomes more and more widespread, its shortcomings are gradually emerging. For example, most of the treatment protocols used in clinical studies are based on personal experience of the investigators, a unified protocol has not yet been formed, treatment methods are still insufficient in standardization and reproducibility. More studies focus solely on the improvement of a certain symptom by a certain rehabilitation therapy, but ignore the important theoretical basis of the "holistic concept", thus showing the uneven clinical efficacy. For the above existing problems, it is necessary to conduct original and innovative research.
Detailed description
This randomized controlled trial will enroll 188 PSA patients from the Third Affiliated Hospital of Zhejiang Chinese Medical University, Zhejiang General Hospital of Armed Police, Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University, and Jinhua Second Hospital. All patients will be randomly assigned to either the integrated rehabilitation group or the standard care group through a randomization system. The primary outcome will be assessed by hamilton anxiety (HAMA) scale, self-rating anxiety scale (SAS), and activity of daily living (ADL) scale. Secondary outcomes will include montreal cognitive assessment (MoCA) scale, the simple fugl-meyer assessment of motor function (FMA) scale and pittsburgh sleep quality index (PSQI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated rehabilitation group | Experimental | Procedure: AcupunctureThis group will include 94 patients. On the basis of standard care, patients in this group will receive acupuncture, traditional Chinese medicine, repetitive transcranial magnetic stimulation. |
| Standard care group | Active comparator | Procedure: AcupunctureThe patients were recommended to take one oral tablet of escitalopram oxalate (10 mg) every morning after a meal for 4 weeks. Internal medicine includes lipid regulation, blood sugar control, anti-hypertension, anticoagulation, and other drugs. Moreover, general duty nursing and motor therapy are also needed. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Meet the diagnostic criteria of cerebral infarction or cerebral hemorrhage with anxiety disorder, the type of depression and clinical syndrome of liver stagnation transforming into fire;
- Patients with clear consciousness, stable vital signs, ability to understand and cooperate with instructions, barthel index (BI) > 20, FMA (0-95), Mini-mental State Examination (MMSE) meet the following criteria: illiterate > 17, primary school level > 20, secondary school level (including technical secondary school) > 22, and college level (including junior college) > 23 points;
- 25 <= age <= 85 years, male or female;
- First episode of stroke, no personal or family history of mental disability before the stroke;
- Anxiety level as mild or moderate (HAMA scores >= 7 and <= 21);
Key exclusion criteria (8 listed)
- Patients with acute brain trauma, brain infection, effusion, or tumor occupation;
- There are intracranial metals and other foreign bodies (such as orthopedic materials, arterial clips, etc.), cardiac pacemakers, deep brain stimulators and other electronic devices;
- Previous seizures, including primary and secondary seizures；
- Patients have severe complications in cardiovascular, liver, kidney or psychiatric history;
- There is a significant cognitive impairment (MMSE: literacy <= 17, primary school level <= 20, secondary school level (including technical secondary school) <= 22, and college level (including junior college) <= 23 points) or hearing impairment, aphasia;
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 |
|---|---|---|
| AcupunctureAlso: Traditional Chinese medicine, Repetitive transcranial magnetic stimulation, Standard careAcupuncture: Scalp acupuncture includes middle line of forehead (MS1), a front line by the forehead (MS2), and middle line of vertex (MS5), these acupoints are needled for 1 inch with the direction with scalp tilted 15-30 degrees. Body acupuncture includes Yintang (DU29), Taichong (LR3), Shenmen (HT7), Neiguan (PC6), Danzhong (RN17), Tongli (HT5), Xingjian (LR2). Traditional Chinese medicine Danzhixiaoyao Power: Danpi 10g, fried Zhizi 10g, Danggui 12g, Baishao 12g, fried Chaihu 6g, Fuling 10g, fried Baishu 10, roasted Gancao 3g. Repetitive transcranial magnetic stimulation The CCY-I magnetic field stimulator from Wuhan Irid Medical Equipment New Technology Co is used, with a frequency of 1Hz. Standard care The same as the standard care group. | Procedure or surgery | Integrated rehabilitation group, Standard care group |
Primary outcome
Change in hamilton anxiety (HAMA) scale
Time frame: Baseline, at 4-week during treatment, at 8-week follow-up
The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).
Change in self-rating anxiety scale (SAS)
Time frame: Baseline, at 4-week during treatment
The Zung Self-Rating Anxiety Scale (SAS) is a method of measuring levels of anxiety in patients who have anxiety-related symptoms. The scale focuses on the most common general anxiety disorders; coping with stress typically causes anxiety. The SAS test is self-administered, with each response using a 4-point scale, from 'none of the time" to "most of the time." There are 20 questions with 15 increasing anxiety level questions and 5 decreasing anxiety questions. There are two formats, self-evaluations and clinical evaluations.
Change in activity of daily living (ADL) scale
Time frame: Baseline, at 4-week during treatment, at 8-week follow-up
The Activities of Daily Living are a series of basic activities necessary for independent living at home or in the community. They are performed on a daily basis. There are many variations on the definition of the ADLs, but most organizations agree there are 5 basic categories.
3 secondary outcomes
Change in Montreal cognitive assessment (MoCA) scale
Time frame: Baseline, at 4-week during treatment
Change in the Fugl-meyer assessment of motor function (FMA) scale
Time frame: Baseline, at 4-week during treatment
Change in Pittsburgh sleep quality index (PSQI)
Time frame: Baseline, at 4-week during treatment, at 8-week follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Derived from this study: PubMed 36097565Zhou J, Fan L, Hu H, Shen K, Wu L, Lin X, Gao H. The Efficacy of Integrated Rehabilitation for Post-Stroke Anxiety: Study Protocol for a Prospective, Multicenter, Randomized Controlled Trial. Int J Gen Med. 2022 Sep 6;15:7101-7111. doi: 10.2147/IJGM.S381434. eCollection 2022.
- 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.
Hong Gao, Deputy dean principal investigator
Third Affiliated Hospital of Zhejiang Chinese 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 Acupuncture in people with Post-stroke and Anxiety, run by The Third Affiliated hospital of Zhejiang Chinese 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 8 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 27 Jun 2022. 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 Hong Gao, Deputy dean (+8618072982566, qtgh@vip.qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hamilton anxiety (HAMA) scale (time frame: Baseline, at 4-week during treatment, at 8-week follow-up). 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 NCT05147077, 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 27 Jun 2022.