Post-stroke Cognitive ImpairmentNCT06458348
Local Opera Viewing Combined Medical Gymnastics for Elderly PSCI
A study testing Local opera appreciating and Medical gymnastics training in people with Post-stroke Cognitive Impairment, run by Zhangzhou Municipal Hospital.
Trial summary
local opera viewing combined medical gymnastics for elderly PSCI Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Post-stroke Cognitive Impairment
- What is being tested?
- Local opera appreciating and Medical gymnastics training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 31 Aug 2026
- 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 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke patients who were hospitalized in the Department of Neurology of Zhangzhou Hospital and met the PSCI diagnostic criteria of the Expert Consensus on the Prevention and Treatment of Cognitive Impairment after Stroke in China were the subjects of the study. ① Stroke patients confirmed by neuroimaging, onset time within 1 week; (2) Cognitive impairment occurs after stroke events; ③ The scores of the simple mental state examination scale were points in the illiterate group, points in the primary school group, points in the secondary school group, and points in the college group; ④ can maintain independent sitting position ≥30 min; ⑤ Age ≥60 years old; ⑥ Volunteer to join the study and receive intervention treatment.
Who cannot join
- Other causes affect or lead to cognitive impairment, such as consciousness disorder, malignant tumor, severe liver and kidney insufficiency; ② There are serious cardiopulmonary and other systemic diseases; Visual or hearing impairment; ④ have emotional behavior abnormalities and mental illness (including depression); ⑤ A history of alcohol or drug abuse
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Construction and Empirical Study of Local Opera Appreciation Combined With Medical Gymnastics Training Program for Elderly Patients With Post-stroke Cognitive Impairment
local opera viewing combined medical gymnastics for elderly PSCI
Read the detailed description
Cognitive impairment and hemiplegia are the two major problems faced by elderly patients with cognitive impairment after stroke. The application of local drama viewing and combined medical gymnastics training aims to improve sports and cognitive function. Local drama viewing and medical gymnastics training integrates drama art cognition and medical sports, is a beneficial scientific attempt.
To construct a local opera viewing combined medical gymnastics training program for elderly patients with post-stroke cognitive impairment, and to explore its feasibility, acceptability and safety.
- Conditions
- Post-stroke Cognitive Impairment
- Being tested
- Local opera appreciating and Medical gymnastics training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local opera appreciating and Medical gymnastics trainingBehavioural
To construct a local opera viewing combined medical gymnastics training program for elderly patients with post-stroke cognitive impairment, and to explore its feasibility, acceptability and safety.
| Study group | Role | What they receive |
|---|---|---|
| Local opera appreciating | Experimental | Received the local drama viewing .When the PSCI patient was hospitalized and discharged for 12 weeks. appreciating local drama for 30-45 minutes every day Receives: Behavioral: Local opera appreciating and Medical gymnastics training |
| Medical gymnastics training | Experimental | Conducted medical gymnastics training .When the PSCI patient was hospitalized and discharged for 12 weeks. conduct medical gymnastics training for 30-45 minutes every day Receives: Behavioral: Local opera appreciating and Medical gymnastics training |
| Local opera appreciating and Medical gymnastics training | Experimental | Received the drama viewing and conducted the medical gymnastics training .When the PSCI patient was hospitalized and discharged for 12 weeks. Appreciating local drama for 30-45 minutes and conduct medical gymnastics training for 30-45 minutes every day Receives: Behavioral: Local opera appreciating and Medical gymnastics training |
| Routine treatment | No intervention | When the PSCI patient was hospitalized and discharged for 12 weeks, Received the routine treatment and care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIH stroke scale, NIHSS
NIHSS is based on structural neurological examination and gives a score between 0 and 42. Higher scores indicate a more severe neurological deficit . The NIHSS-score 5 indicates mild neurological deficit, and 5 to 15 indicates moderate neurological deficit score> 20 generally considered to indicate "severe" stroke, whereas patients with isolated severe aphasia (NIHSS score 2 or 3) may have damaging . Nerve deficit (NIHSS) , which involves 15 factors such as movement, sensory, visual field, and the score range from 0 to 42. The deficit is divided into three grades: mild, moderate and severe, respectively 0-15,16~30 and 31~42 points.
Measured: Before and at 3 months after the intervention
Muscle strength
When level 6 (level 0~5) muscle strength recording method, let the patient do the muscle contraction movement in turn, the examiner give resistance, or When the patient was instructed to maintain a position, the examiner tried to change the position to determine muscle strength (Table 4-3). Six-level recording method of attack 4-3 muscle strength
Level 0 Complete paralysis, with no muscle contraction Level 1 Muscles can contract, but can not act Level 2 The limb can move on the bed surface, but can not resist their own gravity, that is, can not lift Level 3 The limb can resist gravity off the bed surface, but can not resist resistance Level 4 The body can do antiresistance movements, but not completely Level 5 Normal muscle strength
Measured: Before and at 3 months after the intervention
Montreal cognitive assessment, MoCA-Beijing
The version includes eight aspects of cognitive domain test: memory, visual space, execution, attention, computing, language, time orientation, location orientation, total score of 30 points, the higher the score, the cognitive function of the better, the illiterate group 13 points, elementary school group 19 points, junior high school and above test 24 points can be judged as impaired cognitive function impaired , to correct the cultural bias. MoCA, specifically designed for screening MCI, has high sensitivity (80% to 100%) and specificity (50% to 7 6%) in identifying MCI.
Measured: Before and at 3 months after the intervention
Mini-Mental State Examination, MMSE
MMSE is the first simple tool compiled by Folstein et al. to assess cognitive function. After practice, it is gradually used for screening of dementia patients, judge the severity of cognitive impairment and track the changes of the condition. Its sensitivity in dementia screening diagnosis is 80-90% and specificity is 70-80% . The scale covers cognitive domains such as directional force, memory, attention and calculation, speech, and visual space. The scale has 30 entries with a total score of 30, which can be graded according to MMSE, with 21 to 26 mild dementia, 11 to 20 moderate dementia, and 0 to 10 severe dementia . This study adopted the version revised by domestic scholar Wang Zhengyu et al. , with 30 items and a total of 30 points. The abnormal score was divided into 17 points for illiterate group, 20 points in primary school group and 24 points in middle school and above group. AD patients with this scale was excluded in this study.
Measured: Before and at 3 months after the intervention
Secondary outcomes (5)
Hamilton Anxiety Rating Scale
The Hamilton Anxiety Scale (Hamilton Anxiety Scale, HAMA) is the most clinically used to assess anxiety symptoms in adults For a wide range of his evaluation tools.14 items, using 5 grades ranging from 0 to 4. Higher scores indicate greater anxiety.
Measured: Before and at 3 months after the intervention
Hamilton Depression Rating Scale
The Hamilton Depression Scale (Hamilton DepressionScaleHAMD) clinically evaluates depressive symptoms in adults .The most widely used evaluation tools. There are three versions of 17 items, 21 items, and 24 items. Most of the items use 5 grades of 0 to 4, but a few Grade 3 score from 0 to 2. Higher scores indicate greater depression.
Measured: Before and at 3 months after the intervention
Pittsburgh Sleep Quality Index
MMSE is the first simple tool compiled by Folstein et al. to assess cognitive function. After practice, it is gradually used for screening of dementia patients, judge the severity of cognitive impairment and track the changes of the condition. Its sensitivity in dementia screening diagnosis is 80-90% and specificity is 70-80% . The scale covers cognitive domains such as directional force, memory, attention and calculation, speech, and visual space. The scale has 30 entries with a total score of 30, which can be graded according to MMSE, with 21 to 26 mild dementia, 11 to 20 moderate dementia, and 0 to 10 severe dementia [93]. This study adopted the version revised by domestic scholar Wang Zhengyu et al. [69], with 30 items and a total of 30 points. The abnormal score was divided into 17 points for illiterate group, 20 points in primary school group and 24 points in middle school and above group. AD patients with this scale was excluded in this study.
Measured: Before and at 3 months after the intervention
Stroke Impact Scale，SIS
In order to evaluate how much stroke affects PSCI health and life, to know the PSCI own views on the impact of stroke. questions about the dysfunction caused by stroke and the impact on the life of PSCI
Measured: Before and at 3 months after the intervention
Subscales of the Functional Assessment of Communication Skills, SFACS
SFACS was developed by Frattali et al in 1995 .2015 Chinese by Chen Huiying. This scale was originally used in patients with aphasia, and was later widely used by other scholars in dementia, stroke, brain trauma and other fields. It evaluates the communication functions from four domains , Each domain has four qualitative dimensions. There are 43 entries in this scale, which takes about 20 minutes, and the scoring standard is a 7-point system: 1= not completed, 2= need a large amount of assistance, 3 = general to large amount of assistance, 4= general assistance, 5 = small amount to general assistance, 6= small amount of assistance, 7 = completed independently. FACS can evaluate communication skills using either the total questionnaire or subscales, with higher scores indicating better communication skills.
Measured: Before and at 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke Cognitive ImpairmentStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhangzhou Municipal Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Biyun Xiao, MSc, Principal investigator, Zhangzhou Municipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458348
- Sponsor's protocol ID
- Zhangzhou Municipal Hospital
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Empirical Study of Local Opera Appreciation Combined With Medical Gymnastics Training Program for Elderly Patients With Post-stroke Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06458348
- Acronym / sponsor ID
- Zhangzhou Municipal Hospital
- Conditions
- Post-stroke Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Zhangzhou Municipal HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 13 Jun 2024 (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.
local opera viewing combined medical gymnastics for elderly PSCI
Detailed description
Cognitive impairment and hemiplegia are the two major problems faced by elderly patients with cognitive impairment after stroke. The application of local drama viewing and combined medical gymnastics training aims to improve sports and cognitive function. Local drama viewing and medical gymnastics training integrates drama art cognition and medical sports, is a beneficial scientific attempt.
To construct a local opera viewing combined medical gymnastics training program for elderly patients with post-stroke cognitive impairment, and to explore its feasibility, acceptability and safety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Local opera appreciating | Experimental | Behavioral: Local opera appreciating and Medical gymnastics trainingReceived the local drama viewing .When the PSCI patient was hospitalized and discharged for 12 weeks. appreciating local drama for 30-45 minutes every day |
| Medical gymnastics training | Experimental | Behavioral: Local opera appreciating and Medical gymnastics trainingConducted medical gymnastics training .When the PSCI patient was hospitalized and discharged for 12 weeks. conduct medical gymnastics training for 30-45 minutes every day |
| Local opera appreciating and Medical gymnastics training | Experimental | Behavioral: Local opera appreciating and Medical gymnastics trainingReceived the drama viewing and conducted the medical gymnastics training .When the PSCI patient was hospitalized and discharged for 12 weeks. Appreciating local drama for 30-45 minutes and conduct medical gymnastics training for 30-45 minutes every day |
| Routine treatment | No intervention | –When the PSCI patient was hospitalized and discharged for 12 weeks, Received the routine treatment and care. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stroke patients who were hospitalized in the Department of Neurology of Zhangzhou Hospital and met the PSCI diagnostic criteria of the Expert Consensus on the Prevention and Treatment of Cognitive Impairment after Stroke in China were the subjects of the study. ① Stroke patients confirmed by neuroimaging, onset time within 1 week; (2) Cognitive impairment occurs after stroke events; ③ The scores of the simple mental state examination scale were points in the illiterate group, points in the primary school group, points in the secondary school group, and points in the college group; ④ can maintain independent sitting position ≥30 min; ⑤ Age ≥60 years old; ⑥ Volunteer to join the study and receive intervention treatment.
Key exclusion criteria (1 listed)
- Other causes affect or lead to cognitive impairment, such as consciousness disorder, malignant tumor, severe liver and kidney insufficiency; ② There are serious cardiopulmonary and other systemic diseases; Visual or hearing impairment; ④ have emotional behavior abnormalities and mental illness (including depression); ⑤ A history of alcohol or drug abuse
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 |
|---|---|---|
| Local opera appreciating and Medical gymnastics trainingTo construct a local opera viewing combined medical gymnastics training program for elderly patients with post-stroke cognitive impairment, and to explore its feasibility, acceptability and safety. | Behavioural | Local opera appreciating, Local opera appreciating and Medical gymnastics training, Medical gymnastics training |
Primary outcome
NIH stroke scale, NIHSS
Time frame: Before and at 3 months after the intervention
NIHSS is based on structural neurological examination and gives a score between 0 and 42. Higher scores indicate a more severe neurological deficit . The NIHSS-score 5 indicates mild neurological deficit, and 5 to 15 indicates moderate neurological deficit score> 20 generally considered to indicate "severe" stroke, whereas patients with isolated severe aphasia (NIHSS score 2 or 3) may have damaging . Nerve deficit (NIHSS) , which involves 15 factors such as movement, sensory, visual field, and the score range from 0 to 42. The deficit is divided into three grades: mild, moderate and severe, respectively 0-15,16~30 and 31~42 points.
Muscle strength
Time frame: Before and at 3 months after the intervention
When level 6 (level 0~5) muscle strength recording method, let the patient do the muscle contraction movement in turn, the examiner give resistance, or When the patient was instructed to maintain a position, the examiner tried to change the position to determine muscle strength (Table 4-3). Six-level recording method of attack 4-3 muscle strength Level 0 Complete paralysis, with no muscle contraction Level 1 Muscles can contract, but can not act Level 2 The limb can move on the bed surface, but can not resist their own gravity, that is, can not lift Level 3 The limb can resist gravity off the bed surface, but can not resist resistance Level 4 The body can do antiresistance movements, but not completely Level 5 Normal muscle strength
Montreal cognitive assessment, MoCA-Beijing
Time frame: Before and at 3 months after the intervention
The version includes eight aspects of cognitive domain test: memory, visual space, execution, attention, computing, language, time orientation, location orientation, total score of 30 points, the higher the score, the cognitive function of the better, the illiterate group 13 points, elementary school group 19 points, junior high school and above test 24 points can be judged as impaired cognitive function impaired , to correct the cultural bias. MoCA, specifically designed for screening MCI, has high sensitivity (80% to 100%) and specificity (50% to 7 6%) in identifying MCI.
Mini-Mental State Examination, MMSE
Time frame: Before and at 3 months after the intervention
MMSE is the first simple tool compiled by Folstein et al. to assess cognitive function. After practice, it is gradually used for screening of dementia patients, judge the severity of cognitive impairment and track the changes of the condition. Its sensitivity in dementia screening diagnosis is 80-90% and specificity is 70-80% . The scale covers cognitive domains such as directional force, memory, attention and calculation, speech, and visual space. The scale has 30 entries with a total score of 30, which can be graded according to MMSE, with 21 to 26 mild dementia, 11 to 20 moderate dementia, and 0 to 10 severe dementia . This study adopted the version revised by domestic scholar Wang Zhengyu et al. , with 30 items and a total of 30 points. The abnormal score was divided into 17 points for illiterate group, 20 points in primary school group and 24 points in middle school and above group. AD patients with this scale was excluded in this study.
5 secondary outcomes
Hamilton Anxiety Rating Scale
Time frame: Before and at 3 months after the intervention
Hamilton Depression Rating Scale
Time frame: Before and at 3 months after the intervention
Pittsburgh Sleep Quality Index
Time frame: Before and at 3 months after the intervention
Stroke Impact Scale，SIS
Time frame: Before and at 3 months after the intervention
Subscales of the Functional Assessment of Communication Skills, SFACS
Time frame: Before and at 3 months after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
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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.
Biyun Xiao, MSc principal investigator
Zhangzhou Municipal Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Local opera appreciating and Medical gymnastics training in people with Post-stroke Cognitive Impairment, run by Zhangzhou Municipal Hospital.
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 1 inclusion and 1 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 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Hui Jiang (17744055727, baiyundao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIH stroke scale, NIHSS (time frame: Before and at 3 months after the intervention). The study lists 4 primary outcomes in all. 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 13 Jun 2024.