An interventional study of early mobilization and early standard intervention in Hemorrhagic Stroke, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-04-12.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
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.
233 studies on the registry are indexed under Hemorrhagic Stroke; 93 are open to participants now.
This study's enrollment of 60 is close to the median of 58 across 156 interventional studies indexed under Hemorrhagic Stroke.
Browse Hemorrhagic Stroke studies →National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
The inclusion criteria will be as follows:
The exclusion criteria will be as follows:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.)
Behavioral: early mobilization
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.
Behavioral: early standard intervention
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.
Conventional early in-bed activities within three days after stroke
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.
Time frame: baseline, 2-week, 4-week and three months after stroke
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.
Time frame: 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.
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)
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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline to within 3 months after stroke
Ran from Sep 2017 to primary completion in Nov 2018, 13 months.
Of 75 non-industry interventional studies with no phase under Hemorrhagic Stroke, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 57. This study's 13 months is below that.
Counting every sponsor, half of 89 studies reached it within 36 months; a quarter within 14 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Taiwan University Hospital →