Local Opera Viewing Combined Medical Gymnastics for Elderly PSCI

NCT06458348 | Not Yet Recruiting

• 1 other identifier: Zhangzhou Municipal Hospital
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

local opera viewing combined medical gymnastics for elderly PSCI

Conditions

Post-stroke Cognitive Impairment

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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.

  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.

  Before and at 3 months after the intervention

Secondary Outcomes (5)

• Hamilton Anxiety Rating Scale

  Before and at 3 months after the intervention

• Hamilton Depression Rating Scale

  Before and at 3 months after the intervention

• Pittsburgh Sleep Quality Index

  Before and at 3 months after the intervention

• Stroke Impact Scale，SIS

  Before and at 3 months after the intervention

• Subscales of the Functional Assessment of Communication Skills, SFACS

  Before and at 3 months after the intervention

Study Arms (4)

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

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

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

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.

Interventions

Local opera appreciating and Medical gymnastics training BEHAVIORAL

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.

Local opera appreciating; Local opera appreciating and Medical gymnastics training; Medical gymnastics training

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhangzhou Municipal Hospital: lead

Study Officials

• Biyun Xiao, MSc

  Zhangzhou Municipal Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Jiang

CONTACT

17744055727; baiyundao@163.com

Biyun Xiao, MSc

CONTACT

13960036388; 1248677502@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 13, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: June 13, 2024

Record last verified: 2024-06