- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07018102
- Original Trial
Nurse-Led Bedside Trunk Control Care Program
March 16, 2026 updated by: Hsiang Chu Pai, Chung Shan Medical University
Nurse-Led Bedside Trunk Control Care Program for Patients With Stroke
This study aimed to apply care for stroke survivors by establishing trustable professional activities competency indicators and a trunk control care module for rehabilitation ward nurses during our second year.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
Thus, the purposes of this study were: (1) to evaluate the effect of a stepwise nurse-led bedside trunk control care module intervention on improving trunk control, respiratory function, and quality of life in patients with stroke and (2) to modify and confirm the milestones and trustable professional activities of competence in trunk impairment care for patients with stroke to provide evidence-based nursing education and cultivate new nurses' competence in trunk injury care in the future.
Study Type
Interventional
Enrollment (Estimated)
130
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taichung, Taiwan, 40201
- Chung Shan Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- (a) Patients hospitalized for stroke in rehabilitation or neurology wards, currently in stable condition; (b) Trunk Impairment Scale score below 21; (c) aged 20 or above; (d) patients willing to participate.
Exclusion Criteria:
- Patients with Trunk Impairment Scale score above 21, as this indicates that they can perform daily activities independently
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Trunk Control Care Program
A step-wise nurse-led bedside trunk control care module intervention
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|
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No Intervention: standard care
The control group received routine care including health education on turning over, positioning, and wheelchair use.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trunk function
Time Frame: Questionnaire were filled out three times, before the program intervention and at the two and fourth weeks following the intervention.
|
Trunk Impairment Scale is used to assess patients' trunk function.
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Questionnaire were filled out three times, before the program intervention and at the two and fourth weeks following the intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postural control
Time Frame: Questionnaire were filled out three times, before the program intervention and at the two and fourth weeks following the intervention.
|
Postural Assessment Scale for Stroke is used to assess patients' postural.
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Questionnaire were filled out three times, before the program intervention and at the two and fourth weeks following the intervention.
|
|
Respiratory function
Time Frame: Questionnaire were filled out three times, before the program intervention and at the two and fourth weeks following the intervention.
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Respiratory function was assessed by the technical staff in the rehabilitation ward.
examination room
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Questionnaire were filled out three times, before the program intervention and at the two and fourth weeks following the intervention.
|
|
Body awareness
Time Frame: Questionnaire were filled out three times, before the program intervention and at the two and fourth weeks following the intervention.
|
Body Awareness Questionnaire is used to assess patients' body awareness.
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Questionnaire were filled out three times, before the program intervention and at the two and fourth weeks following the intervention.
|
|
stroke impact
Time Frame: Questionnaire were filled out three times, before the program intervention and at the two and fourth weeks following the intervention.
|
Stroke Impact Scale is used to assess patients' quality of life.
|
Questionnaire were filled out three times, before the program intervention and at the two and fourth weeks following the intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hsiang Chu Pai, PhD, Chung Shan Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2025
Primary Completion (Estimated)
October 30, 2026
Study Completion (Estimated)
October 30, 2026
Study Registration Dates
First Submitted
June 4, 2025
First Submitted That Met QC Criteria
June 4, 2025
First Posted (Actual)
June 12, 2025
Study Record Updates
Last Update Posted (Actual)
March 18, 2026
Last Update Submitted That Met QC Criteria
March 16, 2026
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS1-23077
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
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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