UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004484 |
|---|---|
| Receipt number | R000005365 |
| Scientific Title | A randomized controlled trial of early rising for patients with aneurysmal subarachnoid hemorrhage |
| Date of disclosure of the study information | 2010/10/31 |
| Last modified on | 2014/05/05 15:50:28 |
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Basic information
Public title
A randomized controlled trial of early rising for patients with aneurysmal subarachnoid hemorrhage
Acronym
A randomized controlled trial of early rising for patients with aneurysmal subarachnoid hemorrhage
Scientific Title
A randomized controlled trial of early rising for patients with aneurysmal subarachnoid hemorrhage
Scientific Title:Acronym
A randomized controlled trial of early rising for patients with aneurysmal subarachnoid hemorrhage
Region
| Japan |
Condition
Condition
Subarachnoid hemorrhage due to the ruptur of aneurysm
Classification by specialty
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We validate by randomized controlled trials about the effect of early rising in patients who underwent the clipping of a ruptured aneurysm with subarachnoid hemorrhage, which prevent disuse syndrome and complications of bed rest, and improve ADL independence and conscious level and accelerate the discharge of home.
Furthermore, we show the effect of early rising of cerebral vasospasm occurrence.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
1)Length of stay
2)Discharge destination
3)ADL
4)Presence of disuse syndrome
Key secondary outcomes
1)Implementing rehabilitation period
2)Length of stay
3)Discharge destination
4)Level of consciousness
5)The presence of gait acquisition
6)ADL
7)MMSE
8)Limb circumference
9)Presence of leg pain
10)Presence of orthostatic hypotension
11)Presence of urinary tract infection
12)The presence of pneumonia
13)The presence of spasm occurred (symptomatic)
14)Presence of hydrocephalus caused
15)modified Ranking Scale (mRs)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
1)As soon as possible after surgery (within approximately 4 days) to begin rehabilitation.
2)Provide basic training from day one intervention.
3)Training up the bed, sitting training, standing training, strength training in a standing position,evaluation and training of higher brain functions, ADL training.
4)Gait training after removal of the draining tube.
5)Twice a day, PT, OT interventions in these programs. One measure of 20 to 40 minutes.
Interventions/Control_2
1)As soon as possible after surgery (within approximately 4 days) to begin rehabilitation.
2)Provide basic training from day one intervention.
3)Continue even after the second day of basic training. Evaluate the higher brain functions.
4)Gait training after removal of the draining tube.
5)Twice a day, PT, OT interventions in these programs. One measure of 20 to 40 minutes.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)WFNS grade 1~4
2)Patients underwent the clipping surgery
3)Patients whose intracranial pressure is controlled
4)Patients without contraindications to heart disease exercise
5)Patients who obtained permission from doctors
6) Patients in hospital
Key exclusion criteria
1)Patients with contraindications to exercise in heart disease
2) Patients who are judged to be inappropriate for subjects from doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Tsutsumi |
Organization
Showa General Hospital
Division name
Neurosurgery
Zip code
Address
2-450 Tenjinchyo,Kodaira-city,Tokyo
TEL
042-461-0052
k.tsutsumi-md@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taeko Fuchi |
Organization
Showa General Hospital
Division name
Rehabilitation
Zip code
Address
2-450 Tenjinchyo,Kodaira-city,Tokyo
TEL
042-461-0052
Homepage URL
reha@showa-hp.jp
Sponsor or person
Institute
Showa General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
公立昭和病院（東京都)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 31 | Day |
Last modified on
| 2014 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005365
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