UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000039969
Receipt No. 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 (Ver. 1)

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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
Institute Hamamatsu City Rehabilitation Hospital
Department of Rehabilitation
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045523