UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001986
Receipt No. R000002424
Scientific Title Hybrid Assistive Neuromuscular Dynamic Stimulation (HANDS) therapy for patients with chronic stroke
Date of disclosure of the study information 2009/06/01
Last modified on 2016/04/18

* 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 Hybrid Assistive Neuromuscular Dynamic Stimulation (HANDS) therapy for patients with chronic stroke
Acronym Hybrid Assistive Neuromuscular Dynamic Stimulation (HANDS) therapy for patients with chronic stroke
Scientific Title Hybrid Assistive Neuromuscular Dynamic Stimulation (HANDS) therapy for patients with chronic stroke
Scientific Title:Acronym Hybrid Assistive Neuromuscular Dynamic Stimulation (HANDS) therapy for patients with chronic stroke
Region
Japan

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

Objectives
Narrative objectives1 We devised a therapeutic approach to facilitate the use of the paretic UE in daily life by combining integrated volitional control electrical stimulation (IVES) with a wrist splint, the hybrid assistive neuromuscular dynamic stimulation (HANDS). The aim of this study is to assess its effects on selected measures of hand function and impairments
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Fugl-Meyer score
Motor activity log
Stroke Impairment Assessment Set
Key secondary outcomes Muscle tone
Computer aided arm function test

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are 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 Hybrid assistive dynamic stimulation for 3 weeks
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. the time from stroke onset longer than 150 days 2. no cognitive deficits 3. no pain in the paretic upper extremity 4. passive extension range of motion (ROM) greater than 0 degree of the affected wrist and -10 degree of metacarpopharyngeal joints 5. detectable surface electromyographic signals in the affected EDC when the patient intended to extend their fingers 6. no severe proprioceptive deficit in the affected upper extremity 7. the ability to walk without physical assistance in daily life 8. no motor improvement in the last 1 month before starting the intervention was confirmed with physicians and patient's testimony.
Key exclusion criteria 1)contraindication to the exercise for severe heart, lung and other disease
2)the patients with pacemaker, shunt and clipping
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyuki Fujiwara
Organization Tokai University School of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address 143 Shimokasuya, Isehara, Kanagawa
TEL 03-5363-3833
Email tofuji@xc5.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiyuki Fujiwara
Organization Tokai University School of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address 143 Shimokasuya, Isehara, Kanagawa
TEL 0463931121
Homepage URL
Email tofuji@xc5.so-net.ne.jp

Sponsor
Institute Department of Rehabilitation Medicien, Keio University School of Medicine
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

Other administrative information
Date of disclosure of the study information
2009 Year 06 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
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
2012 Year 04 Month 27 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2016 Year 03 Month 01 Day
Date of closure to data entry
2016 Year 06 Month 01 Day
Date trial data considered complete
2016 Year 06 Month 01 Day
Date analysis concluded
2016 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 05 Month 20 Day
Last modified on
2016 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002424

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.