UMIN-ICDS Clinical Trial

Public title

The effect of NP-FES (Neuroprosthetic functional electrical stimulation) on upper limb vascular function in elderly patients with hemiplegia

Acronym

The effect of NP-FES (Neuroprosthetic functional electrical stimulation) on upper limb vascular function in elderly patients with hemiplegia

Scientific Title

The effect of NP-FES (Neuroprosthetic functional electrical stimulation) on upper limb vascular function in elderly patients with hemiplegia

Scientific Title:Acronym

The effect of NP-FES (Neuroprosthetic functional electrical stimulation) on upper limb vascular function in elderly patients with hemiplegia B

Region

Japan

Condition

stroke

Classification by specialty

Cardiology	Neurology	Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To determine the effects of continuous Neuroprosthetic functional electrical stimulation (NP-FES) on peripheral circulatory function in living-phase hemiplegics.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Venous vessel width (before and after energization) Measurements at baseline, 1 week, 2 weeks, 3 weeks, and 4 weeks after intervention 1 and intervention 2 for 2 cools.

Key secondary outcomes

Skin surface temperature, venous oxygenation index, estimated hemoglobin level (before and after energization) Measurements at baseline, 1, 2, 3, and 4 weeks after intervention 1 and intervention 2 for 2 cools.

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Intervention 1: Dorsiflexion movement with energization under 70 Hz conditions for 4 minutes. The rhythm of the energization consists of 2 seconds of energization and 2 seconds of rest. This will be performed twice a week. The washout period will be 2 weeks. The intensity of the stimulation should be the maximum intensity that can be tolerated by the individual producing the joint movement.

Interventions/Control_2

Intervention 2: 4 minutes of energization under 70 Hz conditions, followed by dorsiflexion. The rhythm of the energization consists of 2 seconds of energization and 2 seconds of rest. This will be performed twice a week. The washout period will be 2 weeks. The intensity of the stimulation should be about the level of sensory energization, and joint movements should not be produced.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

45

years-old

<=

Age-upper limit

90

years-old

>

Gender

Male and Female

Key inclusion criteria

Hemiplegics were defined as having at least 3 lower extremities and 4 fingers at the Brunnstrom stage (BRS).

Key exclusion criteria

Patients with the following conditions were excluded. Those with peripheral neuropathy, Mini Mental State Examination (MMSE) scores of 10 or less, and those with severe dementia who were unable to make decisions on their own regarding cooperation in the study.

Target sample size

20

Name of lead principal investigator

1st name	Masaya
Middle name
Last name	Tanabe

Organization

Gunma PAZ University

Division name

Department of Physical Therapy, Faculty of Rehabilitation

Zip code

370-0006

Address

1-7-1 Tonyamachi, Takasaki City, Gunma Prefecture

TEL

0273653366

Email

tanabe@paz.ac.jp

Name of contact person

1st name	Masaya
Middle name
Last name	Tanabe

Organization

Gunma PAZ University

Division name

Department of Physical Therapy, Faculty of Rehabilitation

Zip code

3700006

Address

1-7-1 Tonyamachi, Takasaki City, Gunma Prefecture

TEL

0273653366

Homepage URL

Email

tanabe@paz.ac.jp

Institute

Gunma PAZ University

Institute

Department

Personal name

TanabeMasaya

Organization

Gunma PAZ University

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Gunma Perth University Ethics Review Committee

Address

1-7-1 Tonyamachi, Takasaki City, Gunma Prefecture

Tel

0273653366

Email

tanabe@paz.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

06

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

05

Month

22

Day

Date of IRB

Anticipated trial start date

2023

Year

06

Month

01

Day

Last follow-up date

2024

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

06

Month

07

Day

Last modified on

2023

Year

06

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058128