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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038399
Receipt No. R000043755
Scientific Title Effects of combined exercise level NMES and exercise therapy on hemiplegic upper limbs in patients with severe stroke on upper limb recovery
Date of disclosure of the study information 2019/11/10
Last modified on 2019/10/27

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Basic information
Public title Effects of combined exercise level NMES and exercise therapy on hemiplegic upper limbs in patients with severe stroke on upper limb recovery
Acronym Effects of combined exercise level NMES and exercise therapy on hemiplegic upper limbs in patients with severe stroke on upper limb recovery
Scientific Title Effects of combined exercise level NMES and exercise therapy on hemiplegic upper limbs in patients with severe stroke on upper limb recovery
Scientific Title:Acronym Effects of combined exercise level NMES and exercise therapy on hemiplegic upper limbs in patients with severe stroke on upper limb recovery
Region
Japan

Condition
Condition Cerebrovascular disease
Classification by specialty
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to examine the degree of improvement of upper limb function in patients with severe upper limb paralysis by comparing the group with NMES combined with exercise therapy and the group with only exercise therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1)Automatic motion angle of shoulder joint by two-dimensional motion analysis
(2)Muscle activity of the anterior deltoid muscle, triceps, and extensor extensor muscles by surface electromyography

Measure on the day before treatment, immediately before and after treatment, and the next day after treatment program
Key secondary outcomes (1) Stroke Impairment Assessment Set (SIAS)
(2) Upper extremities, fingers Brunnstrom Recovery Stage (BRS)
(3) Upper limb Fugl-Meyer Assessment (FMA)
(4) Manual Function Test (MFT)
(5) Number of grips
(6) Modified Ashworth scale (MAS)
(7) Jikei Assessment Scale for Motor Impairment in Daily Living (JASMID)
(8) Functional independence Measure (FIM)
(9) Barthel Index (BI)

Measure on the day before the treatment, the second week of treatment (the 14th day), and the day after the treatment program

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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
Device,equipment
Interventions/Control_1 The standard schedule for this study is to complete 27 treatment programs (described below) in 4 weeks.
In this study, ESPURGE (manufactured by Ito Ultra-shortwave Co., Ltd.) is used.

1) Forward sanding with one hand (automatic assistance)
Treatment time: 15 minutes

2) wrist joint dorsiflexion, finger extension exercise (automatic assistance exercise)
Treatment time: 10 minutes
Current-carrying part: Total finger extensor

The energization strength shall be the maximum strength within the range that the patient can withstand in both 1) and 2).
Current-carrying site: deltoid anterior fiber, triceps
Interventions/Control_2 The standard schedule for this study is to complete 27 treatment programs in 4 weeks.
1) Forward sanding with one hand (automatic assistance)
Treatment time: 15 minutes
2) wrist joint dorsiflexion, finger extension exercise (automatic assistance exercise)
Treatment time: 10 minutes

* 1), 2) Both use a metronome and repeat for 5 seconds and 5 seconds of rest.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria (1) Patients who can obtain consent to participate in research by voluntary intention in writing. If the patient has the ability to consent but writing is difficult due to disability, etc., confirm that the patient has agreed to participate in the study, and obtain consent from the family or key person .
(2) Patients whose age at the time of obtaining consent is between 20 and 90 years old.
(3) Patients with stroke recovery (within 6 months [180 days] from the onset of stroke).
(4) Patients who have not had paralysis on the same side as the present onset.
(5) Patients with upper extremities and fingers I-II at the Brunnstrom Recovery Stage (BRS).
(6) Patients with stable general condition such as blood pressure, pulse and blood glucose level.
Key exclusion criteria (1) Patients whose upper limb function training is judged to be difficult due to dyspnea during work, heart failure, arrhythmia, or myocardial infarction.
(2) Patients with a history of neurological disorders or upper limb joint diseases that affect upper limb function.
(3) Patients who have advanced complications such as degenerative shoulder and elbow arthritis, poorly controlled rheumatoid arthritis, scoliosis, osteoporosis, etc., and upper limb function training is difficult or symptoms are worsened by upper limb training.
(4) Patients with severe liver disorder, renal disorder, cardiovascular disease.
(5) Patients with higher brain dysfunction such as severe consciousness disorder, sensory disturbance or ataxia, aphasia
(6) Contraindication examples of electrical stimulation therapy.
Using implantable electronic devices (such as pacemakers), patients with heart disease, malignant tumor, tuberculosis disease, or acute disease, extremely weak, pregnant or possibly pregnant, using metal implants Who is.
Other persons deemed inappropriate by doctors.
A person with abnormal blood pressure, fever, or infectious disease.
(7) Patients who cannot apply electrode pads due to skin diseases.
(8) Patients who need other treatments that affect the study due to fractures, trauma and other diseases at the time of obtaining consent.
(9) Those deemed to be maladapted by doctors when participating in this study
When an appropriate response to electrical stimulation cannot be obtained.
When significant improvement in upper limb function is observed.
Target sample size 14

Research contact person
Name of lead principal investigator
1st name ryuji
Middle name
Last name sugawara
Organization International University of Health and Welfare Graduate School
Division name Department of Occupational Therapy, Department of Health Sciences
Zip code 286-8686
Address 4-3, Kozu, Narita-shi, Chiba
TEL 080-5550-9308
Email 19s1239@g.iuhw.ac.jp

Public contact
Name of contact person
1st name ryuji
Middle name
Last name sugawara
Organization International University of Health and Welfare Graduate School
Division name Department of Occupational Therapy, Department of Health Sciences
Zip code 286-8686
Address 4-3, Kozu, Narita-shi, Chiba
TEL 080-5550-9308
Homepage URL
Email 19s1239@g.iuhw.ac.jp

Sponsor
Institute International University of Health and Welfare Graduate School
Institute
Department

Funding Source
Organization International University of Health and Welfare Graduate School
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization International University of Health and Welfare, University Ethics Review Facility Committee, Otawara District Office
Address 2600-1 Kitakanemaru, Otawara-shi, Tochigi
Tel 0287-24-3000
Email s-rinri@iuhw.ac.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

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 10 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 Enrolling by invitation
Date of protocol fixation
2019 Year 11 Month 10 Day
Date of IRB
2019 Year 08 Month 01 Day
Anticipated trial start date
2019 Year 11 Month 10 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 10 Month 27 Day
Last modified on
2019 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043755

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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