UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039969
Receipt number R000045523
Scientific Title Verification of the effectiveness of stroke rehabilitation using Screw Block
Date of disclosure of the study information 2020/04/06
Last modified on 2020/03/27 21:54:15

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Basic information

Public title

Verification of the effectiveness of stroke rehabilitation using Screw Block

Acronym

Verification of the effectiveness of stroke rehabilitation using Screw Block

Scientific Title

Verification of the effectiveness of stroke rehabilitation using Screw Block

Scientific Title:Acronym

Verification of the effectiveness of stroke rehabilitation using Screw Block

Region

Japan


Condition

Condition

stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

it is unclear to what extent Screw Block affects upper limb function in stroke patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

STEF(simple upper limb function test)
Evaluations were performed at the start and end.

Key secondary outcomes

Ueda's 12-stage hemiplegic function test, JASMID(as the parameter of the amount of paralyzed upper limbs use), self-efficacy, mood / emotional evaluation, GSES (as the parameter of self Efficacy), VAS (Visual analogue Scale about depression, vigor and enjoyment), FIM (functional independence evaluation)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

The study was conducted for 3 weeks including the evaluation at the start and end of each group (5 times a week, 15 times in total)
The experimental group received Screw Block for 20 minutes in addition to the usual occupational therapy (20 to 40 minutes)

Interventions/Control_2

The control group received regular occupational therapy including upper limb function training for 40-60 minutes. No screw block was used in the control group

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Subjects were hemiplegic patients by stroke, 20 years or older admitted to our hospital from April 2017 to April 2019. The degree of motor paralysis of the upper limb was at least 7 of Ueda's 12-stage hemiplegic function test upper limb,fingers or at least Brunnstrom Recovery Stage 3 of upper limb,fingers, and the screw block could be grasped voluntarily

Key exclusion criteria

To exclude other symptoms such as higher cerebral dysfunction as exclusion criteria, 1) patients who had recurrent or multiple brain lesions with unclear responsible lesions 2) patients with Ueda's 12-stage hemiplegic function test 6 or less (BRS2 or less), 3) dementia patients who cannot communicate, 4) aphasia with difficult command understanding. 5 ) patients with sensory impairment (loss), 6) patients with severe physical agnosia

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Naoya
Middle name
Last name Akiyama

Organization

Hamamatsu City Rehabilitation Hospital

Division name

Department of Rehabilitation

Zip code

433-8511

Address

Shizuoka Prefecture Hamamatsu City Wagoukita1-6-1

TEL

053-471-8331

Email

akinao-ana@sis.seirei.or.jp


Public contact

Name of contact person

1st name Naoya
Middle name
Last name Akiyama

Organization

Hamamatsu City Rehabilitation Hospital

Division name

Department of Rehabilitation

Zip code

433-8511

Address

Shizuoka Prefecture Hamamatsu City Wagoukita1-6-1

TEL

053-471-8331

Homepage URL


Email

akinao-ana@sis.seirei.or.jp


Sponsor or person

Institute

Hamamatsu City Rehabilitation Hospital
Department of Rehabilitation

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Hamamatsu University School of Medicine

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hamamatsu City Rehabilitation Hospital

Address

Shizuoka Prefecture Hamamatsu City Wagoukita1-6-1

Tel

053-471-8331

Email

akinao-ana@sis.seirei.or.jp


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

浜松市リハビリテーション病院


Other administrative information

Date of disclosure of the study information

2020 Year 04 Month 06 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

30

Results

The experimental group showed a significant improvement in the mean STEF scores compared to the control group (T=2.252,P=0.032,Cohen's d=0.82) .

Results date posted

2020 Year 03 Month 27 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The subjects were 30 patients aged 20 years or older who were admitted to our hospital from April 2017 to April 2019.

Participant flow


Adverse events

None

Outcome measures

Primary endpoints was STEF (simple upper limb function test)

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 02 Month 08 Day

Date of IRB

2017 Year 02 Month 09 Day

Anticipated trial start date

2017 Year 02 Month 10 Day

Last follow-up date

2019 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 03 Month 27 Day

Last modified on

2020 Year 03 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045523


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name