Integrated Rehabilitation in Treating Post-stroke Anxiety

NCT05147077 | Unknown DMC

• 1 other identifier: 2021ZX010-A
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Post-stroke; Anxiety

Keywords

post-stroke anxiety; integrated rehabilitation; acupuncture; traditional Chinese medicine; repetitive transcranial magnetic stimulation; randomized controlled trial

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

  Baseline, at 4-week during treatment, at 8-week follow-up

Secondary Outcomes (3)

• Change in Montreal cognitive assessment (MoCA) scale

  Baseline, at 4-week during treatment

• Change in the Fugl-meyer assessment of motor function (FMA) scale

  Baseline, at 4-week during treatment

• Change in Pittsburgh sleep quality index (PSQI)

  Baseline, at 4-week during treatment, at 8-week follow-up

Study Arms (2)

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.

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.

Procedure: Acupuncture

Interventions

Acupuncture PROCEDURE

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.

Also known as: Traditional Chinese medicine, Repetitive transcranial magnetic stimulation, Standard care

Integrated rehabilitation group; Standard care group

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• \<= 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

the Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 36097565 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Acupuncture Therapy; Medicine, Chinese Traditional; Transcranial Magnetic Stimulation; Standard of Care

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Medicine, East Asian Traditional; Medicine, Traditional; Magnetic Field Therapy; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Hong Gao, Deputy dean

  Third Affiliated Hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Gao, Deputy dean

CONTACT

+8618072982566; qtgh@vip.qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy dean

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 7, 2021
• Study Start: January 24, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 27, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)