UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038399
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

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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 or person

Institute

International University of Health and Welfare Graduate School

Institute

Department

Personal name



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

Value
https://center6.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