UMIN-CTR Clinical Trial

Basic information
Public title	The effect of purposeful activity and electrical stimulation on the upper limb in a patient with chronic severe hemiplegic upper limb: A crossover randomized controlled trial
Acronym	The effect of purposeful activity and electrical stimulation on the upper limb in a patient with chronic severe hemiplegic upper limb
Scientific Title	The effect of purposeful activity and electrical stimulation on the upper limb in a patient with chronic severe hemiplegic upper limb
Scientific Title:Acronym	The effect of purposeful activity and electrical stimulation on the upper limb in a patient with chronic severe hemiplegic upper limb
Region	Japan

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

Objectives
Narrative objectives1	This retrospective crossover randomized controlled trial aimed to examine the effect of PA-EST on the daily life of patients with chronic severely paralyzed 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	Goal Attainment Scaling Light Motor Activity Log Modified Ashworth Scale US echo

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The subjects were stratified as per sex and physical function; they were then randomly divided into groups A and B. Group A received PA-EST for 3 month, followed by regular stretching and exercise training for 3 month after a rest period of 1 month.
Interventions/Control_2	In group B, stretching exercises were mainly performed for 3 month, and PA-EST was administered for 3 month after a rest period of 1 month.
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	30 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	The subject has lived at home more than three years after the onset of stroke. The subject has motor function of the upper limbs of brunnstrom recovery stage 1 form 3. The subject has intervention of home based occupational therapy at least once a week. The subject can talk about the situation of daily life.
Key exclusion criteria	The subject uses a demand-type cardiac pacemaker. In the subject, the electrical stimulation is directly stimulated by the malignant tumor. The subject has a fracture at the location where the electrical stimulation was applied. Subject has not obtained permission from the attending physician.
Target sample size	8

Research contact person
Name of lead principal investigator	1st name Minami Middle name Seigo Last name male
Organization	Osaka Kawasaki Rehabilitation University
Division name	Department of Occupational Therapy
Zip code	597-0104
Address	158, Mizuma, Kaizuka City, Osaka.
TEL	0724466700
Email	minamise@kawasakigakuen.ac.jp

Public contact
Name of contact person	1st name Minami Middle name Seigo Last name male
Organization	Osaka Kawasaki Rehabilitation University
Division name	Department of Occupational Therapy
Zip code	597-0104
Address	158, Mizuma, Kaizuka City, Osaka.
TEL	0724466700
Homepage URL
Email	minamise@kawasakigakuen.ac.jp

Sponsor
Institute	Osaka Kawasaki Rehabilitation University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka Kawasaki Rehabilitation University
Address	158, Mizuma, Kaizuka City, Osaka.
Tel	0724466700
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	2020 Year 04 Month 01 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	8
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 09 Month 01 Day
Date of IRB	2018 Year 10 Month 11 Day
Anticipated trial start date	2018 Year 12 Month 01 Day
Last follow-up date	2019 Year 12 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	2020 Year 03 Month 02 Day
Last modified on	2020 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045237