Study on the Trajectories of Rehabilitation Compliance in Stroke Patients

• Conditions: Stroke, Acute
• Interventions: Other: observation

• Registration Number: NCT04939896
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Study Start: 2021-01-19
• Status Verified: 2021-06
• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-17
• Last Update Submitted: 2021-06-17
• Study First Posted: 2021-06-25
• Last Update Posted: 2021-06-25
• Primary Completion: 2022-02-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Compliance with rehabilitation	observation	The patients' compliance with rehabilitation was followed up at 2, 6, 8, 12 and 24 weeks after onset, respectively

Primary Outcome Measures

Name	Time	Method
Motor Functional Exercise Compliance Scale for Stroke Patients	Week 24	The full score is 56 points, and the higher the cumulative score of each item, the higher the level of compliance.

Trial Locations

Locations (1)

Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China