UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030080
Receipt number R000034343
Scientific Title Effect of concurrent peripheral nerve stimulation therapy on upper limb function and improvement in the daily living activities of chronic stage stroke patients undergoing low-frequency repetitive transcranial magnetic stimulation therapy and occupational therapy
Date of disclosure of the study information 2017/11/22
Last modified on 2022/03/22 14:38:02

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Basic information

Public title

Effect of concurrent peripheral nerve stimulation therapy on upper limb function and improvement in the daily living activities of chronic stage stroke patients undergoing low-frequency repetitive transcranial magnetic stimulation therapy and occupational therapy

Acronym

Effect of concurrent peripheral nerve stimulation therapy on upper limb function and improvement in the daily living activities of chronic stage stroke patients undergoing low-frequency repetitive transcranial magnetic stimulation therapy and occupational therapy

Scientific Title

Effect of concurrent peripheral nerve stimulation therapy on upper limb function and improvement in the daily living activities of chronic stage stroke patients undergoing low-frequency repetitive transcranial magnetic stimulation therapy and occupational therapy

Scientific Title:Acronym

Effect of concurrent peripheral nerve stimulation therapy on upper limb function and improvement in the daily living activities of chronic stage stroke patients undergoing low-frequency repetitive transcranial magnetic stimulation therapy and occupational therapy

Region

Japan


Condition

Condition

Stroke

Classification by specialty

Neurology Neurosurgery Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to verify the effects of concurrent peripheral nerve stimulation (PNS) therapy on the forearm of the paralyzed side of the body, upper limb function, and improved movement in daily living of the stroke patients with upper limb paralysis underdoing repetitive transcranial magnetic stimulation (r-TMS) therapy and 2-week intensive occupation therapy (OT).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Wolf motor function test

Key secondary outcomes

Fugl-Meyer Assessment
Motor Activity Log


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Apply one hour per day of PNS therapy to the forearm of the paralyzed side of the body during OT to stroke patients with upper limb paralysis who are undergoing r-TMS therapy and 2-week intensive OT.

Interventions/Control_2


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Aged 20 years or older at the time consent was obtained.
Ability to voluntarily extend at least three fingers, including the thumb.
Ability to raise the arm on the affected side to the level of the nipple or higher.
Six months or more have passed since the onset of stroke.
PNS therapy has been prescribed by the patient's physician.
Patients who gave voluntary written informed consent after receiving an adequate explanation regarding their participation in the study.

Key exclusion criteria

Severe aphasia, agnosia, apraxia, or other severe higher brain dysfunction that interferes with the procedures of the study.
Cutaneous anesthesia.
Having an inflammatory disease with arthritic inflammation, such as rheumatoid arthritis.
Previous participation in this study.
Previous history of receiving concurrent PNS therapy with r-TMS therapy.
Patients who have otherwise been determined to be ineligible as a subject by the principal investigator.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Hitoshi
Middle name
Last name Mutai

Organization

Shinshu University

Division name

Division of occupational therapy, School of health sciences, Faculty of Medicine

Zip code

390-8621

Address

3-1-1, Asahi, Matsumoto, Nagano, Japan

TEL

0263-37-2405

Email

hitmutai@shinshu-u.ac.jp


Public contact

Name of contact person

1st name Hitoshi
Middle name
Last name Mutai

Organization

Shinshu University

Division name

Division of occupational therapy, School of health sciences, Faculty of Medicine

Zip code

390-8621

Address

3-1-1, Asahi, Matsumoto, Nagano, Japan

TEL

0263-37-2405

Homepage URL


Email

hitmutai@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University

Institute

Department

Personal name



Funding Source

Organization

Shinshu University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shinshu University Independent Ethics Committee

Address

3-1-1, Asahi, Matsumoto, Nagano, Japan

Tel

0263-37-2572

Email

mdrinri@shinshu-u.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

鹿教湯病院(長野県)


Other administrative information

Date of disclosure of the study information

2017 Year 11 Month 22 Day


Related information

URL releasing protocol

https://journals.sagepub.com/doi/full/10.1177/1569186120901633

Publication of results

Published


Result

URL related to results and publications

https://journals.sagepub.com/doi/full/10.1177/1569186120901633

Number of participants that the trial has enrolled

11

Results

The Wolf Motor Function Test, Fugl-Meyer Assessment, and Motor Activity Log showed significant improvement after intervention in the peripheral nerve stimulation group. In particular, hand scores on the Fugl-Meyer Assessment improved significantly in the peripheral nerve stimulation group compared to controls (median change: 2 vs. 0; p = 0.021, r = 0.49).

Results date posted

2020 Year 12 Month 22 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The subjects were chronic stroke patients who participated in a two-week inpatient programme including repetitive transcranial magnetic stimulation and occupational therapy.

Participant flow

the peripheral nerve stimulation group (11 patients who underwent peripheral nerve stimulation)

Adverse events

Nothing

Outcome measures

Wolf motor function test, Fugl-Meyer Assessment, Motor Activity Log

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 11 Month 07 Day

Date of IRB

2017 Year 11 Month 13 Day

Anticipated trial start date

2017 Year 11 Month 22 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry

2019 Year 03 Month 28 Day

Date trial data considered complete

2019 Year 03 Month 28 Day

Date analysis concluded

2019 Year 10 Month 13 Day


Other

Other related information



Management information

Registered date

2017 Year 11 Month 22 Day

Last modified on

2022 Year 03 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034343


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name