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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032025
Receipt No. R000036544
Scientific Title Effect of sensory program on functional recovery of hemiplegic upper limb in acute stroke patients
Date of disclosure of the study information 2018/04/01
Last modified on 2018/03/30

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Basic information
Public title Effect of sensory program on functional recovery of hemiplegic upper limb in acute stroke patients
Acronym Effect of sensory program on functional recovery of hemiplegic upper limb in acute stroke patients
Scientific Title Effect of sensory program on functional recovery of hemiplegic upper limb in acute stroke patients
Scientific Title:Acronym Effect of sensory program on functional recovery of hemiplegic upper limb in acute stroke patients
Region
Japan

Condition
Condition stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to test whether the recovery of upper limb function in stroke patients would be enhanced by additionally carrying training aimed at improving sensory function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Brunnstrom stage
Handgrip strength
Tactile-pressure threshold
Simple test for evaluating hand function (STEF)
Key secondary outcomes Changes in handgrip strength, tactile pressure threshold, and STEF

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Intervention group
<Rehabilitation program>
1.ROM (Range of motion) training
2.facilitation (voluntary promotion training)
3.Muscle-strengthening exercise
4.Mobility skill exercises such as transferring, sitting up and Walking exercises
5.Standard of Exercises for ADL
6.Higher brain dysfunction training
<Sensory training program>
Several types of discrimination task performed under blind condition.
1.Three types of sandpaper, cloth (fur, satin fabric, linen cloth), 3 types of materials (0.5mm sponge cushioning materials, bubble wrap, flat plastic plate)
2.Braille plate
Interventions/Control_2 Control group
<Rehabilitation program>
1.ROM (Range of motion) training
2.facilitation (voluntary promotion training)
3.Muscle-strengthening exercise
4.Mobility skill exercises such as transferring, sitting up and Walking exercises
5.Standard of Exercises for ADL
6.Higher brain dysfunction training
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 Medically stable
Had no peripheral neuropathy or history of other neurological conditions
Had adequate comprehension of instructions and perceptual ability for testing
All were assessed to be free of unilateral neglect using clinical observation and standard neuropsychological assessment (shape cancellation and line bisection)
The Mini-Mental State Examination, which all of them passed (border line passing score of 24)
Key exclusion criteria Any participants that does not meet the conditions specified in the above shall be null and void
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Murata
Organization Nagasaki University
Division name Graduate School of Biomedical Sciences
Zip code
Address 1-7-1 Sakamoto, Nagasaki 852-8520, Japan
TEL 095-819-7923
Email jmura@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Murata
Organization Nagasaki University
Division name Graduate School of Biomedical Sciences
Zip code
Address 1-7-1 Sakamoto, Nagasaki 852-8520, Japan
TEL 095-819-7923
Homepage URL
Email jmura@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Ministry of Education
Organization
Division
Category of Funding Organization Japanese Governmental office
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 国立病院機構長崎医療センター/National Hospital Organization
Nagasaki Medical center

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 01 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 No longer recruiting
Date of protocol fixation
2015 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 30 Day
Last modified on
2018 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036544

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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