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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003832
Receipt No. R000004620
Scientific Title A randomized controlled trial about the effectiveness of prism adaptation therapy on patients with unilateral spatial neglect.
Date of disclosure of the study information 2010/06/28
Last modified on 2010/06/28

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Basic information
Public title A randomized controlled trial about the effectiveness of prism adaptation therapy on patients with unilateral spatial neglect.
Acronym The effectiveness of prism adaptation therapy on unilateral spatial neglect
Scientific Title A randomized controlled trial about the effectiveness of prism adaptation therapy on patients with unilateral spatial neglect.
Scientific Title:Acronym The effectiveness of prism adaptation therapy on unilateral spatial neglect
Region
Japan

Condition
Condition Patients with left unilateral spatial neglect caused by cerebral stroke
Classification by specialty
Cardiology Neurology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Unilateral spatial neglect (USN) is defined as a failure to report, respond, or orient to novel or meaningful stimuli, presented to the side opposite to the brain lesion. The most important clinical problem of USN is that it can interfere with the rehabilitation processes and cause poor functional outcome. Various rehabilitation techniques are explored for USN.
Rossetti and collegues reported, for the first time, that short term adaptation for rightward optical shift induced with prismatic lenses improved performance on various standard tests of left USN. Long-term effects (as long as 5 weeks) were also reported following an intensive twice-daily adaptation program for 2 weeks. However, there has been no randomized controlled trial (RCT) with sufficient sample size examining the effects of PA, and few studies are available demonstrating improvement not only in neuropsychological examinations but also in activities of daily living (ADL) with PA.
If greater efficacy of rehabilitation can be brought about by intervening USN early in the rehabilitation process, patients with USN might achieve higher ADL goals.
The purpose of this RCT is to test if PA improves functional outcomes for stroke patients with USN in the subacute stage.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Behavioral inattention test (BIT), Catherine Bergego scale (CBS)
Time of assessment:at admission, just after intervention, at discharge
Key secondary outcomes Motor score of stroke impairment assessment set (SIAS), Functional independence measure (FIM)
Time of assessment:at admission, just after intervention, at discharge

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Patients were seated at a desk on which a wooden table (height 30 cm) was placed. The top of the table had a semicircular shape with a radius of 30 cm, and three targets were marked at the center, right and left corners of its edge. Patients were asked to point to the three targets through the bottom of the table with their index finger according to the instruction of the therapists who directed three points randomly to the patients. First, they repeated the pointing task thirty times without prism glasses. Then they wore prism glasses which sifted their visual field 12 degrees to the right, and repeated pointing ninety times. After the prism adaptation, they took the prism glasses off and repeated pointing sixty times. Patients underwent two daily training sessions which took about 20 minutes for each, 5 days a week for 2 weeks, giving a total of 20 sessions.
The interventions occurred during their regularly scheduled rehabilitation sessions and all other routine interdisciplinary stroke rehabilitation was provided as usual.
Interventions/Control_2 Patients of the control group underwent the same training sessions with neutral plastic glasses instead of the prisms glasses.
The interventions occurred during their regularly scheduled rehabilitation sessions and all other routine interdisciplinary stroke rehabilitation was provided as usual.
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
41 years-old <=
Age-upper limit
89 years-old >=
Gender Male and Female
Key inclusion criteria (1) first ever hemiparetic stroke,
(2) admission within 3 months after the stroke onset,
(3) right hemisphere damage
(4)no severe cognitive impairment (Mini-Mental State Examination: MMSE>15
(5) at least one item scoring less than the cut off value in the standard test of the Behavioral Inattention Test (BIT).
Key exclusion criteria (1)unable to sit on a wheelchair
(2)unable to understand the task because of aphasia or other cognitive impairment, (3) unable to understand Japanese
(4) extremely decreased eyesight
(5) severe hearing loss
(6) unable to reach with the right upper extremity because of restricted range of motion
(7) right upper extremity amputation more proximal to half of the forearm
(8) severe position sense deficits of the right fingers because of peripheral neuropathy, etc.
(9) past medical history of head trauma or ventriculoperitoneal shunt
(10) patients' refusal for participation.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuhiro Mizuno
Organization Keio University School of Medicine
Division name Departnment of Rehabilitation Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3833
Email

Public contact
Name of contact person
1st name
Middle name
Last name Katsuhiro Mizuno
Organization Keio University School of Medicine
Division name Departnment of Rehabilitation Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3833
Homepage URL
Email mizuno.katsuhiro@gmail.com

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Tokyo Metropolitan Rehabilitation Hospital
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization JAPAN

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 東京都リハビリテーション病院(東京都)、市川市リハビリテーション病院(千葉県)、慶應義塾大学月が瀬リハビリテーションセンター(静岡県)、輝山会記念病院(長野県)、国立病院機構村山医療センター(東京都)、辻村病院(愛知県)、稲城市立病院(東京都)、旭川リハビリテーション病院(北海道)

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 28 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 Completed
Date of protocol fixation
2005 Year 04 Month 28 Day
Date of IRB
Anticipated trial start date
2005 Year 08 Month 01 Day
Last follow-up date
2007 Year 07 Month 01 Day
Date of closure to data entry
2008 Year 01 Month 01 Day
Date trial data considered complete
2008 Year 03 Month 01 Day
Date analysis concluded
2009 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 06 Month 28 Day
Last modified on
2010 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004620

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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