Unique ID issued by UMIN | UMIN000038399 |
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Receipt number | 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 18:09:59 |
Effects of combined exercise level NMES and exercise therapy on hemiplegic upper limbs in patients with severe stroke on upper limb recovery
Effects of combined exercise level NMES and exercise therapy on hemiplegic upper limbs in patients with severe stroke on upper limb recovery
Effects of combined exercise level NMES and exercise therapy on hemiplegic upper limbs in patients with severe stroke on upper limb recovery
Effects of combined exercise level NMES and exercise therapy on hemiplegic upper limbs in patients with severe stroke on upper limb recovery
Japan |
Cerebrovascular disease
Rehabilitation medicine | Adult |
Others
NO
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.
Efficacy
(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
(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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Device,equipment |
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
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.
20 | years-old | <= |
90 | years-old | >= |
Male and Female
(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.
(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.
14
1st name | ryuji |
Middle name | |
Last name | sugawara |
International University of Health and Welfare Graduate School
Department of Occupational Therapy, Department of Health Sciences
286-8686
4-3, Kozu, Narita-shi, Chiba
080-5550-9308
19s1239@g.iuhw.ac.jp
1st name | ryuji |
Middle name | |
Last name | sugawara |
International University of Health and Welfare Graduate School
Department of Occupational Therapy, Department of Health Sciences
286-8686
4-3, Kozu, Narita-shi, Chiba
080-5550-9308
19s1239@g.iuhw.ac.jp
International University of Health and Welfare Graduate School
International University of Health and Welfare Graduate School
Other
International University of Health and Welfare, University Ethics Review Facility Committee, Otawara District Office
2600-1 Kitakanemaru, Otawara-shi, Tochigi
0287-24-3000
s-rinri@iuhw.ac.jp
NO
2019 | Year | 11 | Month | 10 | Day |
Unpublished
Enrolling by invitation
2019 | Year | 11 | Month | 10 | Day |
2019 | Year | 08 | Month | 01 | Day |
2019 | Year | 11 | Month | 10 | Day |
2020 | Year | 03 | Month | 31 | Day |
2019 | Year | 10 | Month | 27 | Day |
2019 | Year | 10 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043755
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