UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Purposeful activity-based electrical stimulation therapy for hemiplegic stroke patients in recovery rehabilitation
Acronym	Effect of Purposeful activity-based electrical stimulation therapy for hemiplegic stroke patients in recovery rehabilitation: randomized-control trial
Scientific Title	Effect of Purposeful activity-based electrical stimulation therapy for hemiplegic stroke patients in recovery rehabilitation: randomized-control trial
Scientific Title:Acronym	Effect of Purposeful activity-based electrical stimulation therapy for hemiplegic stroke patients in recovery rehabilitation: randomized-control trial
Region	Japan

Condition
Condition	Stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to perform PA-EST(Purposeful Activity and Electrical Stimulation Therapy) on patients with severe hemiplegic upper limbs in the convalescent ward and confirm the effects of daily activities on the upper limbs.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fugl Meyer Assessment
Key secondary outcomes	Motor activity log, Functional independence measure, etc.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	PA-EST(Purposeful Activity and Electrical Stimulation Therapy: PA-EST) /functional occupational therapy
Interventions/Control_2	Frequency: 5 times or more / week Time: about 60 minutes Duration: 1-2 months or 3 months
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	40 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	The subjects were selected as those who entered the recovery phase rehabilitation ward and had a Hasegawa dementia rating scale-revised of 28 points or more, and the Fugl Meyer Assessment (FMA) motor function (upper limbs / lower limbs) of 50 points or less. In addition, the FMA upper limb score was 30 points or less. The condition is occupational therapy intervention, and cognitive function is capable of conversation in daily life.
Key exclusion criteria	Exclusion criteria were those with a history of seizures, those with a pacemaker, and those with prominent higher brain dysfunction.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Minami Middle name Last name Seigo
Organization	Gunma Paz University
Division name	Faculty of Rehabilitation
Zip code	370-0006
Address	1-7-1 Tonyamachi, takasaki-city, Gunma
TEL	027-365-3366
Email	seigo.minami@gmail.com

Public contact
Name of contact person	1st name Minami Middle name Last name Seigo
Organization	Gunma Paz University
Division name	Faculty of Rehabilitation
Zip code	597-0104
Address	1-7-1 Tonyamachi, takasaki-city, Gunma
TEL	027-365-3366
Homepage URL
Email	seigo.minami@gmail.com

Sponsor
Institute	Gunma Paz University
Institute
Department

Funding Source
Organization	Gunma Paz 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	Osaka Kawasaki Rehabilitation University, Japan
Address	158, Mizuma, Kaizuka, Osaka, Japan
Tel	0727766700
Email	minamise@kawasakigakuen.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

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 02 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	16
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	2018 Year 08 Month 18 Day
Date of IRB	2018 Year 10 Month 11 Day
Anticipated trial start date	2018 Year 11 Month 11 Day
Last follow-up date	2021 Year 07 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 03 Month 02 Day
Last modified on	2021 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049506