Study on the Trajectories of Rehabilitation Compliance in Stroke Patients

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04939896
Collaborator
(none)
300
1
34.4
8.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Study on the Trajectories of Rehabilitation Compliance in Stroke Patients Based on Latent Growth Mixture Model
Actual Study Start Date :
Jan 19, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Motor Functional Exercise Compliance Scale for Stroke Patients [Week 2]

    The full score is 56 points, and the higher the cumulative score of each item, the higher the level of compliance.

  2. Motor Functional Exercise Compliance Scale for Stroke Patients [Week 6]

    The full score is 56 points, and the higher the cumulative score of each item, the higher the level of compliance.

  3. Motor Functional Exercise Compliance Scale for Stroke Patients [Week 8]

    The full score is 56 points, and the higher the cumulative score of each item, the higher the level of compliance.

  4. Motor Functional Exercise Compliance Scale for Stroke Patients [Week 12]

    The full score is 56 points, and the higher the cumulative score of each item, the higher the level of compliance.

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang China 310009

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04939896
Other Study ID Numbers:
  • 2020-1062
First Posted:
Jun 25, 2021
Last Update Posted:
Jun 25, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 25, 2021