UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013920 |
|---|---|
| Receipt number | R000016193 |
| Scientific Title | Effectiveness of robot-assisted reaching exercise program for hemiparetic upper extremity: A multicenter, randomized, controlled trial |
| Date of disclosure of the study information | 2014/05/09 |
| Last modified on | 2025/05/21 11:13:16 |
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Basic information
Public title
Effectiveness of robot-assisted
reaching exercise program for
hemiparetic upper extremity: A
multicenter, randomized, controlled
trial
Acronym
Effectiveness of vibration and electrical stimulation for the upper
paretic extremity after stroke: A randomized, sham-controlled trial using a reaching-exercise device with unloading the arm
Scientific Title
Effectiveness of robot-assisted
reaching exercise program for
hemiparetic upper extremity: A
multicenter, randomized, controlled
trial
Scientific Title:Acronym
Effectiveness of vibration and electrical stimulation for the upper
paretic extremity after stroke: A randomized, sham-controlled trial using a reaching-exercise device with unloading the arm
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of
vibration and electrical stimulation during reaching exercise using a device with unloading the arm in patients with poststroke hemiparesis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer Assessment (FMA),
Brunnstrom Stage (BRS), Stroke
Impairment Assessment Set (SIAS),
Modified Ashworth Scale (MAS),
Action Research Arm Test (ARAT),
Reaching ability
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Reaching exercise with unloading the arm, with vibration and electrical stimulation
Interventions/Control_2
Reaching exercise with unloading the arm, without vibration and electrical stimulation
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) Upper paretic extremity after a
new, single stroke
2) Unilateral cerebral hemisphere
stoke
3) Four to 23 weeks duration after stroke onset
4) Ability to sit on the chair for 15 min
5) Affected arm with ability to reach
10 cm both vertically and horizontally
without vibration, without electrical
stimulation, without unloading the arm (From 1 to 60 times/one minute)
Key exclusion criteria
1) Contraindication for vibration or
electrical stimulation
2) Severe arm contracure
3) Severe arm pain
4) Anesthesia at arm
5) Aphasic, perceptual, apraxic, or cognitive deficits that would prevent adequate study participation
6) Inability to provide informed
consent
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Shimodozono |
Organization
Kagoshima University Graduate
School of Medical and Dental
Sciences
Division name
Department of Rehabilitation Medicine and Physical Medicine
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima City, Kagoshima
TEL
099-275-5339
rihakoza@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Shimodozono |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Department of Rehabilitation Medicine and Physical Medicine
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima City, Kagoshima
TEL
099-275-5339
Homepage URL
rihakoza@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Graduate
School of Medical and Dental
Sciences
Institute
Department
Personal name
Funding Source
Organization
Kagoshima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
YASKAWA ELECTRIC CORPORATION
IRB Contact (For public release)
Organization
Ethics Committee on Clinical Research, Sakuragaoka Campus, Kagoshima University
Address
8-35-1 Sakuragaoka, Kagoshima City, Kagoshima
Tel
099-275-6692
kufsyomu@kuas.kagoshima-u.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
鹿児島大学病院霧島リハビリテーションセンター(鹿児島県)など
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 09 | 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
| 2014 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 09 | Day |
Last modified on
| 2025 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016193
