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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004484
Receipt No. 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

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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
Last 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
Email k.tsutsumi-md@nifty.com

Public contact
1st 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
Email reha@showa-hp.jp

Sponsor
Institute Showa General Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005365

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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