Clinical trial NCT04939896: Study on the Trajectories of Rehabilitation Compliance in Stroke Patients
Official title: Study on the Trajectories of Rehabilitation Compliance in Stroke Patients Based on Latent Growth Mixture Model
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke, Acute
Keywords: Rehabilitation
stroke
medical adherence
trajectory
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We recruited first-episode stroke patients who needed rehabilitation exercise in the Department of Neurology of a Grade A general hospital.After the approval of the ethics committee of the hospital, the purpose and process of the study were explained to the patients and their families, and the informed consent was signed.

Brief summary: To describe the general trajectories of rehabilitation compliance in first-onset stroke patients within 6 months, and to identify the heterogeneous development trajectory of different subgroups based on the mixed model of latent growth.To explore the predictors of different change tracks of rehabilitation compliance of stroke patients from the perspectives of biological, psychological and social factors, so as to provide the basis for formulating precise nursing intervention measures.

Detailed description: To describe the general trajectories of rehabilitation compliance in first-onset stroke patients within 6 months. To recruit first-onset stroke patients undergoing rehabilitation and collect the general data. Telephone follow-up at 2 weeks, 6 weeks, 8 weeks, 12 weeks and 24 weeks after the onset. Based on the biological-psychosocial medical model and literature, biological, psychological and sociological factors were screened. The patient rehabilitation adherence level in different periods was measured. Latent Growth Mixture Model (LGMM) was used to investigate the general trend of rehabilitation compliance in patients with first-episode stroke within 6 months. Latent Class Growth Analysis (LCGA) method in Latent Growth hybrid model was used to identify the track of heterogeneous change. Multivariate Logistic regression analysis was used to explore the predictors of different subgroups of change trajectories relative to other subgroups.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with stroke by CT or MR;

  * Patients with first onset (within 14 days of onset); ③ limb dysfunction (muscle strength ≤4); ④ Age: ≥18 years old; ⑤ Awareness (NIHSS consciousness level ≤1 point);

    * Informed consent of patients.

Exclusion Criteria:

* Patients with deep vein thrombosis;

  * fracture patients;

    * a history of severe cardiopulmonary dysfunction and craniocerebral trauma;

      * recurrent stroke during the study; ⑤patients with severe mental disorders; ⑥ Mixed aphasia patients.

Primary outcomes:
measure: Motor Functional Exercise Compliance Scale for Stroke Patients
timeFrame: Week 2
measure: Motor Functional Exercise Compliance Scale for Stroke Patients
timeFrame: Week 6
measure: Motor Functional Exercise Compliance Scale for Stroke Patients
timeFrame: Week 8
measure: Motor Functional Exercise Compliance Scale for Stroke Patients
timeFrame: Week 12
measure: Motor Functional Exercise Compliance Scale for Stroke Patients
timeFrame: Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Nursing Department Second Affiliated Hospital of Zhejiang University School of Medicine
name: Yuping Yuping, master
role: PRINCIPAL_INVESTIGATOR
References: