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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034191
Receipt No. 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 2018/09/18

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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) and one month later after discharge
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
Middle name
Last name Naoya Anmoto
Organization Nagoya city rehabilitation center
Division name Department of occupational therapy
Zip code
Address Aichi Prefecture Nagoya City Mizuho-ku Yatomi-cho Mikanyama 1-2
TEL 052-835-3811
Email ot-dep@nagoya-rehab.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoya Anmoto
Organization Nagoya city rehabilitation center
Division name Department of occupational therapy
Zip code
Address Aichi Prefecture Nagoya City Mizuho-ku Yatomi-cho Mikanyama 1-2
TEL 052-835-3811
Homepage URL
Email ot-dep@nagoya-rehab.or.jp

Sponsor
Institute Nagoya city rehabilitation center
Institute
Department

Funding Source
Organization None
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
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 名古屋市総合リハビリテーションセンター(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
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
2017 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
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
2018 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_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


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