Study on the Trajectories of Rehabilitation Compliance in Stroke Patients

Stroke, Acute Clinical Trial

Official title:

Study on the Trajectories of Rehabilitation Compliance in Stroke Patients Based on Latent Growth Mixture Model

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04939896
• Other study ID #: 2020-1062
• Status: Recruiting
• Start date: January 19, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: June 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xiaoxu Han, master
• Phone: 18613608661
• Email: 1476894048[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 1, 2023
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with stroke by CT or MR;

• Patients with first onset (within 14 days of onset); ? limb dysfunction (muscle strength =4); ? Age: =18 years old; ? 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; ?patients with severe mental disorders; ? Mixed aphasia patients.

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Other:
• observation
Observed patients' compliance with rehabilitation at different time

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor Functional Exercise Compliance Scale for Stroke Patients	The full score is 56 points, and the higher the cumulative score of each item, the higher the level of compliance.	Week 2
Primary	Motor Functional Exercise Compliance Scale for Stroke Patients	The full score is 56 points, and the higher the cumulative score of each item, the higher the level of compliance.	Week 6
Primary	Motor Functional Exercise Compliance Scale for Stroke Patients	The full score is 56 points, and the higher the cumulative score of each item, the higher the level of compliance.	Week 8
Primary	Motor Functional Exercise Compliance Scale for Stroke Patients	The full score is 56 points, and the higher the cumulative score of each item, the higher the level of compliance.	Week 12
Primary	Motor Functional Exercise Compliance Scale for Stroke Patients	The full score is 56 points, and the higher the cumulative score of each item, the higher the level of compliance.	Week 24