UMIN-ICDS Clinical Trial

Public title

Effect of combination of game-based exercise using a home video game console and peripheral nerve electrical stimulation on physical function in stroke patients.

Acronym

Effect of combination of game-based exercise using a home video game console and peripheral nerve electrical stimulation on physical function in stroke patients.

Scientific Title

Effect of combination of game-based exercise using a home video game console and peripheral nerve electrical stimulation on physical function in stroke patients.

Scientific Title:Acronym

Effect of combination of game-based exercise using a home video game console and peripheral nerve electrical stimulation on physical function in stroke patients.

Region

Japan

Condition

Stroke

Classification by specialty

Neurology	Rehabilitation medicine	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effects of balance exercises combined with electrical peripheral nerve stimulation on motor function in hemiplegic stroke patients.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Primary outcomes

Mini-Balance Evaluation Systems Test
Evaluation time: before and after intervention

Key secondary outcomes

functional balance scale
maximum gait speed
Fugl Meyer assessment
Modified Ashworth Scale
Functional Indedependence Measure
Evaluation time: before and after intervention

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

PNS group
One hour of peripheral nerve electrical stimulation followed by 20 minutes balance exercises using a home video game console, 5 times a week for 4 weeks.

Interventions/Control_2

Sham group
One hour of electrode installation followed by 20 minutes balance exercises using a home video game console, 5 times a week for 4 weeks.

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with first-onset stroke.
Patients with lesions in the cerebral cortex and subcortex.
Patients without difficult-to-intervene cognitive impairment (Mini Mental State Examination over 20 points).
Patients who can stand and walk with supervision.
Patinets who consent to the research.

Key exclusion criteria

Those with a functional balance scale of 45 points or more.
Patients whose ADL decreased during the intervention period due to orthopedic disease, etc.
Patients with acute exacerbation during the intervention period.
Patients with higher brain dysfunction such as pusher syndrome, attention deficits, hemispatial neglect, and apraxia that make intervention difficult.
Patients with unstable blood pressure fluctuations or medical diseases.
Patients with peripheral neuropathy that affects sensory and motor functions in the lower extremities.
pacemaker users.

Target sample size

24

Name of lead principal investigator

1st name	Hiroshi
Middle name
Last name	Okuno

Organization

Kishiwada Rehabilitation Hospital

Division name

Rehabilitation Center

Zip code

596-0827

Address

2-8-10 Kanmatsu-cho, Kishiwada, Osaka 596-0827, Japan

TEL

0724267777

Email

okuno1218works@gmail.com

Name of contact person

1st name	Hiroshi
Middle name
Last name	Okuno

Organization

Kishiwada Rehabilitation Hospital

Division name

Rehabilitation Center

Zip code

596-0827

Address

2-8-10 Kanmatsu-cho, Kishiwada, Osaka 596-0827, Japan

TEL

0724267777

Homepage URL

Email

okuno1218works@gmail.com

Institute

Kishiwada Rehabilitation Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kishiwada Rehabilitation Hospital

Address

Rehabilitation Center

Tel

0724267777

Email

okuno1218works@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

岸和田リハビリテーション病院(大阪)

Date of disclosure of the study information

2022

Year

10

Month

10

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

Completed

Date of protocol fixation

2020

Year

07

Month

29

Day

Date of IRB

2020

Year

07

Month

29

Day

Anticipated trial start date

2020

Year

08

Month

01

Day

Last follow-up date

2022

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

10

Month

07

Day

Last modified on

2023

Year

04

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055988