Hemorrhagic StrokeNCT03292211
The Effect of Early Mobilization in Mild to Moderate Hemorrhagic Stroke
A study testing early mobilization and early standard intervention in people with Hemorrhagic Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study aims to examine the outcomes of early mobilization and early intervention within 24-72 hours after the onset of hemorrhagic stroke in patients admitted to an intensive care unit within 24 hours after stroke. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hemorrhagic Stroke
- What is being tested?
- early mobilization and early standard intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Sep 2017to 10 Feb 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
The inclusion criteria will be as follows:
- patients with a first time intracerebral (either cortical or subcortical) hemorrhage with unilateral hemiparesis/ hemiplegia confirmed by magnetic resonance imaging or computed tomography;
- patients with no contraindications to being mobilized (early intervention) within 24 hours of stroke onset (based on the medical team's clinical judgment: including systolic blood pressure (SBP)<160mmHg in resting; resting heart rate (HR)<130 bpm; no hydrocephalus; 80< mean arterial pressure (MAP)<110 mmHg before intervention);
- patients with National Institutes of Health Stroke Scale (NIHSS) scores at admission ranging from 1 to 20;
- patients with total activity of living independence pre-stroke; and
- patients between 20 and 80 years old.
The exclusion criteria will be as follows:
- patients with mild to moderate deficits as described above (3);
- patients who are unable to complete the baseline survey because of serious aphasia, language difficulties, or cognitive deficits;
- patients with other medical conditions, such as severe heart failure, acute coronary syndrome, or lower-limb disorders, that prevent early mobilization; and
- patients who are unable to provide informed consent. In addition, we will exclude those showing rapid early deterioration of symptoms, as well as those with a concurrent diagnosis of rapidly deteriorating disease (e.g., terminal cancer).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Benefits of Functional Recovery Between the Early Mobilization and Early Conventional Intervention After Stroke for the Patients With Mild to Moderate Hemorrhagic Stroke
This study aims to examine the outcomes of early mobilization and early intervention within 24-72 hours after the onset of hemorrhagic stroke in patients admitted to an intensive care unit within 24 hours after stroke. The patients after hemorrhagic stroke who undergo early intervention only will be compared with those who also receive early mobilization in order to determine if the early mobilization intervention results in earlier or more effective recovery of postural stability, activities of daily living function, or motor capacity.
The participants will be randomly assigned to the following two groups: (1) the early mobilization (+early rehabilitation) group and (2) the early rehabilitation group.The measurement parameters will be collected before the intervention (basic parameters), two weeks after the stroke, four weeks after the stroke and three months after the stroke. SPSS (version 17.0) will be used to carry out repeated measures analysis of variance (repeated ANOVA) to compare the differences between the groups at different time points (including basic values and follow-up values). For statistical significance, Bonferroni correction will be applied for the post-hoc analysis of the groups.
Read the detailed description
Early intervention has been proven to enhance post-stroke functional recovery. Recent studies have proposed that early mobilization (out-of-bed activities) also contributes to an individual's functional improvement after stroke. However, studies on early intervention after stroke have mainly investigated patients with ischemic stroke, while tending to exclude patients with hemorrhagic stroke who were admitted to intensive care units. The main reason for this is the difference between hemorrhagic and ischemic strokes in terms of their mechanisms and treatment methods. Hemorrhagic stroke is characterized by higher severity and fatality rates, and there is a general lack of research on early rehabilitation and mobilization after hemorrhagic strokes. To our knowledge, there have been no previous studies that have simultaneously compared the impact of early mobilization and early rehabilitation starting at the same time on the motor recovery of patients after intracranial hemorrhage. Thus, this study aims to examine the outcomes of early mobilization and intervention within 24-72 hours after the onset of hemorrhagic stroke in patients admitted to an intensive care unit within 24 hours after stroke. The patients will be compared to identify differences in the recovery of postural stability and functional abilities two weeks, four weeks and three months after stroke.
The participants will be randomly assigned to the following two groups: (1) the early mobilization (+early rehabilitation) group and (2) the early rehabilitation group. The early mobilization group will receive early mobilization intervention within24-72 hours after stroke while being monitored by medical equipment. In early mobilization group, this intervention program will most include early out-of-bed activities (that is, rolling and sitting at the edge of the bed). The early rehabilitation group will undergo only conventional early in-bed activities in the stroke center.
All the outcome measures will be collected at baseline (pre-intervention), 2 weeks after stroke, 4 weeks after stroke and three months after stroke.The results will be analyzed with SPSS (IBM SPSS Statistics 17, Chicago, IL, USA). Repeated measures analysis of variance (repeated ANOVA) and the Chi-square test for categorical variables will be used for comparing the outcome data. If there are significant interactions, a post hoc test with Bonferroni correction will be used to examine group differences within a time condition. A p value < 0.05 will be considered statistically significant.
- Conditions
- Hemorrhagic Stroke
- Being tested
- early mobilization, early standard intervention
- Keywords
- Early mobilization, Acute stroke, Early intervention, Early mobilization therapy
- Medical subject headings
- Hemorrhagic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early mobilizationBehavioural
early out-of-bed activities including supine to sit training, sit on the edge of bed without supporting, standing with hand supporting, stepping while standing etc.within three days after stroke while being monitored by medical equipment.
early standard interventionBehavioural
Conventional early in-bed activities within three days after stroke
| Study group | Role | What they receive |
|---|---|---|
| early mobilization | Experimental | early mobilization group will commence rehabilitation consisting of out-of-bed mobilization (including supine to sit training, sit on the edge of bed without supporting, standing with hand supporting, stepping while standing etc.) Receives: Behavioral: early mobilization |
| early standard intervention | Other | early standard intervention included bed exercises including the joint range of motion exercise, bridge exercise, the straight leg raising exercise, stretching exercises, and the facilitation techniques during the period in a stroke center. Receives: Behavioral: early standard intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
the score-change of the Functional Independence Measure (FIM) assessment for daily living function
The functional independence of patient's capacities in terms of activity of daily living. The instrument assesses motor domain including dependence in self-care, sphincter management, transfer, locomotion as well as cognition domain including communication, social interaction and cognition.
Measured: baseline, 2-week, 4-week and three months after stroke
Secondary outcomes (7)
the number of days required to reach a sitting>5 minutes milestone
The milestone will be the ability to sit on the edge of a bed with the feet touching the floor without support > 5 minutes.
Measured: baseline to within 3 months after stroke
the number of days required to reach a standing>1 minute milestone
The milestone will be the ability to stand without support for longer than 1 minute and with the feet freely positioned.
Measured: baseline to within 3 months after stroke
the number of days required to reach a walking>50 meters milestone using the functional ambulation category (FAC)
The milestone will consist of walking on a level surface for a minimum of 50 meters with/without an assistive device while under supervision or required support level
Measured: baseline to within 3 months after stroke
the number of serious adverse events
Immobility-related and neurological serious adverse events include both fatal and non-fatal complications; immobility-related events include pulmonary embolism, deep-vein thrombosis, urinary tract infection, pressure sores, pneumonia; and neurological events include stroke progression and recurrent stroke.
Measured: baseline to within 3 months after stroke
the score-change of the Postural Assessment Scale for Stroke Patients (PASS)
12 four-level items of varying difficulty with a maximum score of 36
Measured: baseline, 2-week, 4-week and three months after stroke
the score-change of systolic blood pressure (SBP) during the acute phase
recorded the absolute SBP values over time
Measured: up to 2 weeks after stroke
the number of days required to stay in the stroke center
the length of stay in the stroke center
Measured: baseline to within 3 months after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start12 Sep 2017
- Primary completion9 Nov 2018
- Study completion10 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemorrhagic StrokeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiann-Shing Jeng, Principal investigator, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292211
- Sponsor's protocol ID
- 201706073RINB
- Status last verified
- Sep 2018
- First submitted
- 10 Sep 2017
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yen HC, Jeng JS, Chen WS, Pan GS, Chuang Pt Bs WY, Lee YY, Teng T. Early Mobilization of Mild-Moderate Intracerebral Hemorrhage Patients in a Stroke Center: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2020 Jan;34(1):72-81. doi: 10.1177/1545968319893294. Epub 2019 Dec 20.
PubMed 31858865
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Benefits of Functional Recovery Between the Early Mobilization and Early Conventional Intervention After Stroke for the Patients With Mild to Moderate Hemorrhagic Stroke
- ClinicalTrials.gov ID
- NCT03292211
- Acronym / sponsor ID
- 201706073RINB
- Conditions
- Hemorrhagic Stroke
- Keywords
- Early mobilization, Acute stroke, Early intervention, Early mobilization therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 9 Nov 2018 (actual)
- Study completion
- 10 Feb 2019 (actual)
- First posted
- 25 Sep 2017 (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 examine the outcomes of early mobilization and early intervention within 24-72 hours after the onset of hemorrhagic stroke in patients admitted to an intensive care unit within 24 hours after stroke. The patients after hemorrhagic stroke who undergo early intervention only will be compared with those who also receive early mobilization in order to determine if the early mobilization intervention results in earlier or more effective recovery of postural stability, activities of daily living function, or motor capacity.
The participants will be randomly assigned to the following two groups: (1) the early mobilization (+early rehabilitation) group and (2) the early rehabilitation group.The measurement parameters will be collected before the intervention (basic parameters), two weeks after the stroke, four weeks after the stroke and three months after the stroke. SPSS (version 17.0) will be used to carry out repeated measures analysis of variance (repeated ANOVA) to compare the differences between the groups at different time points (including basic values and follow-up values). For statistical significance, Bonferroni correction will be applied for the post-hoc analysis of the groups.
Detailed description
Early intervention has been proven to enhance post-stroke functional recovery. Recent studies have proposed that early mobilization (out-of-bed activities) also contributes to an individual's functional improvement after stroke. However, studies on early intervention after stroke have mainly investigated patients with ischemic stroke, while tending to exclude patients with hemorrhagic stroke who were admitted to intensive care units. The main reason for this is the difference between hemorrhagic and ischemic strokes in terms of their mechanisms and treatment methods. Hemorrhagic stroke is characterized by higher severity and fatality rates, and there is a general lack of research on early rehabilitation and mobilization after hemorrhagic strokes. To our knowledge, there have been no previous studies that have simultaneously compared the impact of early mobilization and early rehabilitation starting at the same time on the motor recovery of patients after intracranial hemorrhage. Thus, this study aims to examine the outcomes of early mobilization and intervention within 24-72 hours after the onset of hemorrhagic stroke in patients admitted to an intensive care unit within 24 hours after stroke. The patients will be compared to identify differences in the recovery of postural stability and functional abilities two weeks, four weeks and three months after stroke.
The participants will be randomly assigned to the following two groups: (1) the early mobilization (+early rehabilitation) group and (2) the early rehabilitation group. The early mobilization group will receive early mobilization intervention within24-72 hours after stroke while being monitored by medical equipment. In early mobilization group, this intervention program will most include early out-of-bed activities (that is, rolling and sitting at the edge of the bed). The early rehabilitation group will undergo only conventional early in-bed activities in the stroke center.
All the outcome measures will be collected at baseline (pre-intervention), 2 weeks after stroke, 4 weeks after stroke and three months after stroke.The results will be analyzed with SPSS (IBM SPSS Statistics 17, Chicago, IL, USA). Repeated measures analysis of variance (repeated ANOVA) and the Chi-square test for categorical variables will be used for comparing the outcome data. If there are significant interactions, a post hoc test with Bonferroni correction will be used to examine group differences within a time condition. A p value < 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early mobilization | Experimental | Behavioral: early mobilizationearly mobilization group will commence rehabilitation consisting of out-of-bed mobilization (including supine to sit training, sit on the edge of bed without supporting, standing with hand supporting, stepping while standing etc.) |
| early standard intervention | Other | Behavioral: early standard interventionearly standard intervention included bed exercises including the joint range of motion exercise, bridge exercise, the straight leg raising exercise, stretching exercises, and the facilitation techniques during the period in a stroke center. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 mobilizationearly out-of-bed activities including supine to sit training, sit on the edge of bed without supporting, standing with hand supporting, stepping while standing etc.within three days after stroke while being monitored by medical equipment. | Behavioural | early mobilization |
| early standard interventionConventional early in-bed activities within three days after stroke | Behavioural | early standard intervention |
Primary outcome
the score-change of the Functional Independence Measure (FIM) assessment for daily living function
Time frame: baseline, 2-week, 4-week and three months after stroke
The functional independence of patient's capacities in terms of activity of daily living. The instrument assesses motor domain including dependence in self-care, sphincter management, transfer, locomotion as well as cognition domain including communication, social interaction and cognition.
7 secondary outcomes
the number of days required to reach a sitting>5 minutes milestone
Time frame: baseline to within 3 months after stroke
the number of days required to reach a standing>1 minute milestone
Time frame: baseline to within 3 months after stroke
the number of days required to reach a walking>50 meters milestone using the functional ambulation category (FAC)
Time frame: baseline to within 3 months after stroke
the number of serious adverse events
Time frame: baseline to within 3 months after stroke
the score-change of the Postural Assessment Scale for Stroke Patients (PASS)
Time frame: baseline, 2-week, 4-week and three months after stroke
the score-change of systolic blood pressure (SBP) during the acute phase
Time frame: up to 2 weeks after stroke
the number of days required to stay in the stroke center
Time frame: baseline to within 3 months 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 12 Apr 2019.
- Derived from this study: PubMed 31858865Yen HC, Jeng JS, Chen WS, Pan GS, Chuang Pt Bs WY, Lee YY, Teng T. Early Mobilization of Mild-Moderate Intracerebral Hemorrhage Patients in a Stroke Center: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2020 Jan;34(1):72-81. doi: 10.1177/1545968319893294. Epub 2019 Dec 20.
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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.
Jiann-Shing Jeng principal investigator
NTUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early mobilization and early standard intervention in people with Hemorrhagic Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 12 Apr 2019. 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 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?
the score-change of the Functional Independence Measure (FIM) assessment for daily living function (time frame: baseline, 2-week, 4-week and three months after stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03292211, which also lists 1 linked publication.
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 12 Apr 2019.