UMIN-CTR Clinical Trial

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

Patients with left unilateral spatial neglect caused by cerebral stroke

Classification by specialty

Cardiology	Neurology	Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Keio University School of Medicine

Institute

Department

Personal name

Organization

Tokyo Metropolitan Rehabilitation Hospital

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2010

Year

06

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2010

Year

06

Month

28

Day

Last modified on

2010

Year

06

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004620