Stroke, AcuteNCT05381220
The Effects of Early Mobilization in Stroke Patients on Functional Status, Psychological Distress, and Quality of Life
A study testing early mobilization in people with Stroke, Acute, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
This study aims to investigate the effects of an early mobilization intervention in improving functional status, psychological distress, and quality of life in stroke patients. We hypothesize that this intervention method can significantly alleviate patient anxiety and depression, thereby promoting functional recovery… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- early mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesTaiwan
- Study dates
- 14 Apr 2022to 10 Apr 2023
- Phase
- Interventional
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be over 20 years old.
- Patients diagnosed with infarct or hemorrhagic stroke 24 to 48 hours later. -Patients with stable vital signs, systolic blood pressure between 140- 220mmHg, heartbeat 40-130bpm, blood oxygen >92%.
- The muscle strength of the limbs is greater than 3 points.
- Can communicate in Chinese and Taiwanese.
Who cannot join
- Patients with severe mental illness, critically ill patients and cognitive dysfunction.
- Surgery patients, aphasia patients.
- NIHSS greater than 16 points for severe stroke
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Taiwan University Hospital
Taipei
National Taiwan University Hospital
Taipei County
About this study
This study aims to investigate the effects of an early mobilization intervention in improving functional status, psychological distress, and quality of life in stroke patients. We hypothesize that this intervention method can significantly alleviate patient anxiety and depression, thereby promoting functional recovery and enhancing overall quality of life. Through this research, we hope to provide stroke patients with more effective exercise programs to help them regain health and well-being.
Read the detailed description
This study employs an experimental design conducted on patients in the stroke unit of the hospital who are over 20 years old and have either ischemic or hemorrhagic stroke with stable vital signs post-stroke onset, limb muscle strength greater than 3 points, and good communication skills in Chinese and Taiwanese, or they can read Chinese. Eligible participants are divided into an experimental group and a control group. All participants receive standard stroke unit care, while the intervention group additionally undergoes a 3-day activity protocol. The primary and secondary outcomes are assessed at baseline and at 1, 4, and 12 weeks post-stroke. Finally, the study analyzes the effect of early intervention on improving the prognosis of stroke patients.
The data collected in this study, whether in paper form or electronically, will be documented on a computer. After completing the research report, any recordings and paper documents will be destroyed. Once the data is documented, identifiable patient information will be removed, and each record will be assigned a unique code, making individual data unidentifiable.
- Conditions
- Stroke, Acute
- Being tested
- early mobilization
- Keywords
- stroke, early mobilization
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early mobilizationOther
Patients will receive early mobilization measures within 24 to 48 hours after the onset of stroke.
| Study group | Role | What they receive |
|---|---|---|
| early mobilization in stroke patients | Experimental | Participants in the intervention group commenced early mobilization (EM) within 24-48 hours after stroke onset. The structured program included progressive bed mobility, sitting, standing, and ambulation activities, with intensity and duration adjusted according to each patient's tolerance and neurological stability. Each session lasted approximately 30 minutes, performed once or twice daily, five days per week, and continued until hospital discharge. All sessions were conducted under the supervision of trained rehabilitation nurses and physiotherapists, with progression allowed only when vital signs were stable and no neurological deterioration was observed. Receives: Other: early mobilization |
| usual care in stroke patients | No intervention | Participants will receive routine rehabilitation once daily, consisting of 20 minutes of bed exercises, including both active and passive joint movements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess changes in functional status
Functional status was assessed by Barthel Activity Daily Index (BI) and modified Rankin scale (mRS) were applied to assess activities of daily life with stroke patients. The BI is consisting of 10 common activities of daily living activities. Eight of the ten items represent activities related to personal care; the remaining 2 are related to mobility. A total score out of 100; the higher the score, the greater the degree of functional independence. The mRS scale runs from 0-6, the score of 0 is no disability, 5 is disability requiring constant care for all needs, and 6 is death.
Measured: Data were collected at three measurement time points: baseline, the fourth week, and the 12th week after stroke.
Assess changes in sychological distress
Psychological distress was measured using the Hospital Anxiety and Depression Scale (HADS) scale. It consists of 14 items, which can be divided into two subscales of seven items each: the anxiety subscale (HADS-A) and the depression subscale (HADS-D). The total HADS score was ranged from 0 to 21. A score greater than or equal to 11 indicates that the patient has anxiety or depression.
Measured: Data were collected at three measurement time points: baseline, the fourth week, and the 12th week after stroke.
Secondary outcomes (1)
Assess changes in quality of life
Quality of life was assessed using the Stroke Impact Scale (SIS) Version 3.0, which contains 59 items covering eight domains, including strength, memory and thinking, emotion, communication, activities of daily living/instrumental activities of daily living (ADL/IADL), mobility, hand function, and participation, plus one recovery item. Each domain is scored from 0 to 100, with higher scores indicating better quality of life.
Measured: Data were collected at three measurement time points: baseline, the fourth week, and the 12th week after stroke.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start14 Apr 2022
- Primary completion10 Apr 2023
- Study completion10 Apr 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 National Taiwan University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsiao Lan Wang, University, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381220
- Sponsor's protocol ID
- 202202035RINC
- Status last verified
- Apr 2023
- First submitted
- 24 Apr 2022
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Early Mobilization in Stroke Patients on Functional Status, Psychological Distress, and Quality of Life
- ClinicalTrials.gov ID
- NCT05381220
- Acronym / sponsor ID
- 202202035RINC
- Conditions
- Stroke, Acute
- Keywords
- stroke, early mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 19 May 2022 (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.
This study aims to investigate the effects of an early mobilization intervention in improving functional status, psychological distress, and quality of life in stroke patients. We hypothesize that this intervention method can significantly alleviate patient anxiety and depression, thereby promoting functional recovery and enhancing overall quality of life. Through this research, we hope to provide stroke patients with more effective exercise programs to help them regain health and well-being.
Detailed description
This study employs an experimental design conducted on patients in the stroke unit of the hospital who are over 20 years old and have either ischemic or hemorrhagic stroke with stable vital signs post-stroke onset, limb muscle strength greater than 3 points, and good communication skills in Chinese and Taiwanese, or they can read Chinese. Eligible participants are divided into an experimental group and a control group. All participants receive standard stroke unit care, while the intervention group additionally undergoes a 3-day activity protocol. The primary and secondary outcomes are assessed at baseline and at 1, 4, and 12 weeks post-stroke. Finally, the study analyzes the effect of early intervention on improving the prognosis of stroke patients.
The data collected in this study, whether in paper form or electronically, will be documented on a computer. After completing the research report, any recordings and paper documents will be destroyed. Once the data is documented, identifiable patient information will be removed, and each record will be assigned a unique code, making individual data unidentifiable.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early mobilization in stroke patients | Experimental | Other: early mobilizationParticipants in the intervention group commenced early mobilization (EM) within 24-48 hours after stroke onset. The structured program included progressive bed mobility, sitting, standing, and ambulation activities, with intensity and duration adjusted according to each patient's tolerance and neurological stability. Each session lasted approximately 30 minutes, performed once or twice daily, five days per week, and continued until hospital discharge. All sessions were conducted under the supervision of trained rehabilitation nurses and physiotherapists, with progression allowed only when vital signs were stable and no neurological deterioration was observed. |
| usual care in stroke patients | No intervention | –Participants will receive routine rehabilitation once daily, consisting of 20 minutes of bed exercises, including both active and passive joint movements. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be over 20 years old.
- Patients diagnosed with infarct or hemorrhagic stroke 24 to 48 hours later. -Patients with stable vital signs, systolic blood pressure between 140- 220mmHg, heartbeat 40-130bpm, blood oxygen >92%.
- The muscle strength of the limbs is greater than 3 points.
- Can communicate in Chinese and Taiwanese.
Key exclusion criteria (3 listed)
- Patients with severe mental illness, critically ill patients and cognitive dysfunction.
- Surgery patients, aphasia patients.
- NIHSS greater than 16 points for severe stroke
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 |
|---|---|---|
| early mobilizationPatients will receive early mobilization measures within 24 to 48 hours after the onset of stroke. | Other | early mobilization in stroke patients |
Primary outcome
Assess changes in functional status
Time frame: Data were collected at three measurement time points: baseline, the fourth week, and the 12th week after stroke.
Functional status was assessed by Barthel Activity Daily Index (BI) and modified Rankin scale (mRS) were applied to assess activities of daily life with stroke patients. The BI is consisting of 10 common activities of daily living activities. Eight of the ten items represent activities related to personal care; the remaining 2 are related to mobility. A total score out of 100; the higher the score, the greater the degree of functional independence. The mRS scale runs from 0-6, the score of 0 is no disability, 5 is disability requiring constant care for all needs, and 6 is death.
Assess changes in sychological distress
Time frame: Data were collected at three measurement time points: baseline, the fourth week, and the 12th week after stroke.
Psychological distress was measured using the Hospital Anxiety and Depression Scale (HADS) scale. It consists of 14 items, which can be divided into two subscales of seven items each: the anxiety subscale (HADS-A) and the depression subscale (HADS-D). The total HADS score was ranged from 0 to 21. A score greater than or equal to 11 indicates that the patient has anxiety or depression.
1 secondary outcome
Assess changes in quality of life
Time frame: Data were collected at three measurement time points: baseline, the fourth week, and the 12th week after stroke.
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 19 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Stroke, Acute
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
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.
Hsiao Lan Wang, University principal investigator
National Taiwan University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early mobilization in people with Stroke, Acute, run by National Taiwan University Hospital at 2 sites in Taiwan.
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 4 inclusion and 3 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 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
Assess changes in functional status (time frame: Data were collected at three measurement time points: baseline, the fourth week, and the 12th week after stroke.). The study lists 2 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 19 Nov 2025.