UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000034191
Receipt number R000038971
Scientific Title Efficacy of Modified Constraint-Induced Movement Therapy combined with Robotic Therapy for patients with upper limb paralysis after stroke
Date of disclosure of the study information 2018/09/18
Last modified on 2019/09/22 17:09:21

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Basic information

Public title

Efficacy of Modified Constraint-Induced Movement Therapy combined with Robotic Therapy for patients with upper limb paralysis after stroke

Acronym

Efficacy of Modified Constraint-Induced Movement Therapy combined with Robotic Therapy for patients with upper limb paralysis after stroke

Scientific Title

Efficacy of Modified Constraint-Induced Movement Therapy combined with Robotic Therapy for patients with upper limb paralysis after stroke

Scientific Title:Acronym

Efficacy of Modified Constraint-Induced Movement Therapy combined with Robotic Therapy for patients with upper limb paralysis after stroke

Region

Japan


Condition

Condition

stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study investigated the efficacy of Modified Constraint-Induced Movement Therapy combined with Robotic Therapy using ReoGo-J for subacute patients with upper limb paralysis after stroke

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Fugl-Meyer Assessment(FMA)Upper extremity section
Each outcome is evaluated at baseline(before any rehabilitation), after 3-week, after 6-week(after any rehabilitation)

Key secondary outcomes

Upper-limb/Finger Brunnstrom stage
Simple test for evaluation hand function(STEF)
pain:100mm Visual analogue scale(VAS)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

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

We provide Modified Constraint-Induced Movement Therapy(Modified CIMT) and self-training using ReoGo-J during six weeks for patients with upper limb paralysis after stroke. Each treatment is provided for 40 minutes a day and 5 days per week. Modified CIMT is composed of task-oriented therapy and transfer package.

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

(1)Clinically incipient stroke patients with upper-limb hemiplegia
(2)Patients who experienced a stroke in the previous 4 to 8 weeks 4.
(3)Upper-limb(shoulder/elbow)Brunnstrom stage III or IV at the time of providing informed consent
(4) Age between 20 and 80 years at the time of providing informed consent
(5) Patients who can do self-care themselves at a sitting position

Key exclusion criteria

(1)Brainstem stroke
(2)Vision disorders
(3)Subarachnoid hemorrhage
(4)Severe aphasia
(5)Mini-mental state examination less than 24 points
(6) Inability to remain seated during training
(7) Intense pain in response to external pressure on affected upper limb
(8) Incapable of voluntary consent
(9) Previous experience with robotic rehabilitation of upper-limb hemiplegia
(10) Previous experience with constraint-induced movement therapy of upper-limb hemiplegia
(11) Previous experience with functional electrical stimulation(FES)therapy of upper limb hemiplegia
(12) Cardiac or respiratory disorders that may interfere with rehabilitation
(13) Other neuromuscular diseases
(14) Body weight of 110 kg or more
(15) Other reasons deemed by the investigators or subinvestigators to render the subject unsuitable for treatment with the investigational device

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Naoya
Middle name
Last name Anmoto

Organization

Nagoya city rehabilitation agency

Division name

Division of occupational therapy

Zip code

4678622

Address

1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan

TEL

052-835-3811

Email

ot-dep@nagoya-rehab.or.jp


Public contact

Name of contact person

1st name Naoya
Middle name
Last name Anmoto

Organization

Nagoya city rehabilitation agency

Division name

Division of occupational therapy

Zip code

4678622

Address

1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan

TEL

052-835-3811

Homepage URL


Email

ot-dep@nagoya-rehab.or.jp


Sponsor or person

Institute

Nagoya city rehabilitation agency

Institute

Department

Personal name



Funding Source

Organization

Nagoya city rehabilitation agency

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagoya city rehabilitation agency

Address

1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan

Tel

052-835-3811

Email

soumubu@nagoya-rehab.or.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

名古屋市総合リハビリテーショ事業団(愛知県)


Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 18 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

11

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

Completed

Date of protocol fixation

2017 Year 03 Month 01 Day

Date of IRB

2017 Year 05 Month 26 Day

Anticipated trial start date

2017 Year 06 Month 01 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

2018 Year 09 Month 18 Day

Last modified on

2019 Year 09 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038971


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name