Study on the Trajectories of Rehabilitation Compliance in Stroke Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Acute
• Intervention / Treatment: Other: observation

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Xiaoxu Han, master; Phone Number: 18613608661; Email: 1476894048@qq.com
• Study Contact Backup: Name: Yuping Yuping, master; Phone Number: 15888841161; Email: zhangyuping@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Second Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Yuping Zhang, Master; Phone Number: 15888841161; Email: zhangyuping@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Compliance with rehabilitation; The patients' compliance with rehabilitation was followed up at 2, 6, 8, 12 and 24 weeks after onset, respectively	Other: observation; Observed patients' compliance with rehabilitation at different time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Yuping Yuping, master, Nursing Department Second Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2021
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): June 25, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Rehabilitation; stroke; trajectory; medical adherence
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2020-1062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No