Stroke, AcuteNCT04939896
Study on the Trajectories of Rehabilitation Compliance in Stroke Patients
An observational study of Stroke, Acute, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- observation
- How many people
- 282 participants
- Where
- 1 siteChina
- Study dates
- 19 Jan 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Acute
- Being tested
- observation
- Keywords
- Rehabilitation, stroke, medical adherence, trajectory
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
Observed patients' compliance with rehabilitation at different time
| Study group | Role | What they receive |
|---|---|---|
| Compliance with rehabilitation | The patients' compliance with rehabilitation was followed up at 2, 6, 8, 12 and 24 weeks after onset, respectively Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start19 Jan 2021
- Primary completion1 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuping Yuping, master, Principal investigator, Nursing Department Second Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939896
- Sponsor's protocol ID
- 2020-1062
- Status last verified
- Jun 2021
- First submitted
- 9 Jun 2021
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Trajectories of Rehabilitation Compliance in Stroke Patients Based on Latent Growth Mixture Model
- ClinicalTrials.gov ID
- NCT04939896
- Acronym / sponsor ID
- 2020-1062
- Conditions
- Stroke, Acute
- Keywords
- Rehabilitation, stroke, medical adherence, trajectory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compliance with rehabilitation | – | Other: observationThe patients' compliance with rehabilitation was followed up at 2, 6, 8, 12 and 24 weeks after onset, respectively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients diagnosed with stroke by CT or MR;
Key exclusion criteria (4 listed)
- Patients with deep vein thrombosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationObserved patients' compliance with rehabilitation at different time | Other | Compliance with rehabilitation |
Primary outcome
Motor Functional Exercise Compliance Scale for Stroke Patients
Time frame: Week 2
The full score is 56 points, and the higher the cumulative score of each item, the higher the level of compliance.
Motor Functional Exercise Compliance Scale for Stroke Patients
Time frame: Week 6
The full score is 56 points, and the higher the cumulative score of each item, the higher the level of compliance.
Motor Functional Exercise Compliance Scale for Stroke Patients
Time frame: Week 8
The full score is 56 points, and the higher the cumulative score of each item, the higher the level of compliance.
Motor Functional Exercise Compliance Scale for Stroke Patients
Time frame: Week 12
The full score is 56 points, and the higher the cumulative score of each item, the higher the level of compliance.
Motor Functional Exercise Compliance Scale for Stroke Patients
Time frame: Week 24
The full score is 56 points, and the higher the cumulative score of each item, the higher the level of compliance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuping Yuping, master principal investigator
Nursing Department Second Affiliated Hospital of Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Functional Exercise Compliance Scale for Stroke Patients (time frame: Week 2). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.