UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013920
Receipt number R000016193
Scientific Title Effectiveness of robot-assisted reaching exercise program for hemiparetic upper extremity: A multicenter, randomized, controlled trial
Date of disclosure of the study information 2014/05/09
Last modified on 2023/05/16 10:21:14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effectiveness of robot-assisted
reaching exercise program for
hemiparetic upper extremity: A
multicenter, randomized, controlled
trial

Acronym

Effectiveness of vibration and electrical stimulation for the upper
paretic extremity after stroke: A randomized, sham-controlled trial using a reaching-exercise device with unloading the arm

Scientific Title

Effectiveness of robot-assisted
reaching exercise program for
hemiparetic upper extremity: A
multicenter, randomized, controlled
trial

Scientific Title:Acronym

Effectiveness of vibration and electrical stimulation for the upper
paretic extremity after stroke: A randomized, sham-controlled trial using a reaching-exercise device with unloading the arm

Region

Japan


Condition

Condition

Stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effectiveness of
vibration and electrical stimulation during reaching exercise using a device with unloading the arm in patients with poststroke hemiparesis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Fugl-Meyer Assessment (FMA),
Brunnstrom Stage (BRS), Stroke
Impairment Assessment Set (SIAS),
Modified Ashworth Scale (MAS),
Action Research Arm Test (ARAT),
Reaching ability

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Reaching exercise with unloading the arm, with vibration and electrical stimulation

Interventions/Control_2

Reaching exercise with unloading the arm, without vibration and electrical stimulation

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1) Upper paretic extremity after a
new, single stroke
2) Unilateral cerebral hemisphere
stoke
3) Four to 23 weeks duration after stroke onset
4) Ability to sit on the chair for 15 min
5) Affected arm with ability to reach
10 cm both vertically and horizontally
without vibration, without electrical
stimulation, without unloading the arm (From 1 to 60 times/one minute)

Key exclusion criteria

1) Contraindication for vibration or
electrical stimulation
2) Severe arm contracure
3) Severe arm pain
4) Anesthesia at arm
5) Aphasic, perceptual, apraxic, or cognitive deficits that would prevent adequate study participation
6) Inability to provide informed
consent

Target sample size

42


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Megumi Shimodozono

Organization

Kagoshima University Graduate
School of Medical and Dental
Sciences

Division name

Department of Rehabilitation Medicine and Physical Medicine

Zip code


Address

3930-7 Takachiho, Makizono-cho, Kirishima City, Kagoshima

TEL

0995-78-2538

Email

rihakoza@m2.kufm.kagoshima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Megumi Shimodozono

Organization

Kagoshima University Graduate School of Medical and Dental Sciences

Division name

Department of Rehabilitation Medicine and Physical Medicine

Zip code


Address

3930-7 Takachiho, Makizono-cho, Kirishima City, Kagoshima

TEL

0995-78-2538

Homepage URL


Email

rihakoza@m2.kufm.kagoshima-u.ac.jp


Sponsor or person

Institute

Kagoshima University Graduate
School of Medical and Dental
Sciences

Institute

Department

Personal name



Funding Source

Organization

Kagoshima University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)

YASKAWA ELECTRIC CORPORATION


IRB Contact (For public release)

Organization


Address


Tel


Email



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

鹿児島大学病院霧島リハビリテーションセンター(鹿児島県)など


Other administrative information

Date of disclosure of the study information

2014 Year 05 Month 09 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

No longer recruiting

Date of protocol fixation

2014 Year 05 Month 02 Day

Date of IRB

2013 Year 06 Month 10 Day

Anticipated trial start date

2014 Year 05 Month 08 Day

Last follow-up date

2016 Year 10 Month 17 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 05 Month 09 Day

Last modified on

2023 Year 05 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016193


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name