UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027943 |
|---|---|
| Receipt number | R000030223 |
| Scientific Title | Effects of functional recovery treatments on upper/lower extremity of stroke and fracture patients using art devices |
| Date of disclosure of the study information | 2017/06/26 |
| Last modified on | 2017/12/26 09:32:22 |
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Basic information
Public title
Effects of functional recovery treatments on upper/lower extremity of stroke and fracture patients using art devices
Acronym
Rehabilitation training with art devices for upper/lower extremity
Scientific Title
Effects of functional recovery treatments on upper/lower extremity of stroke and fracture patients using art devices
Scientific Title:Acronym
Rehabilitation training with art devices for upper/lower extremity
Region
| Japan |
Condition
Condition
stroke, fracture, other
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of art device training on upper/lower functions in stroke and fracture patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Profile of Mood States-Brief From Japanese Version
Questionnaire of motivation
TDMS-ST (Two-dimensional Mood Scale-Short Term)
Number of exercises (number of exercises in 10 minutes)
Key secondary outcomes
Active range of motion (shoulder and elbow joint)
Manual Muscle Test
Simple Test for Evaluating Hand Function
Hand Held Dynamometer (knee extension)
30-sec Chair Stand test (CS-30)
Gait speed
Functional Independence Measure
Heart rate
Fugl-Meyer Assessment
Stroke Impairment Assessment Set
Motor Activity Log
Modified Ashworth Scale
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
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Devices for upper limb
Interventions/Control_2
Devices for lower limbs
Interventions/Control_3
Conventional training (Occupational therapy)
Interventions/Control_4
Conventional training (Physical therapy)
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Upper device
1. No pain in the shoulder and elbow joint
2. Patients with voluntary movement
Lower device
1. A patients can stand up (partial assistance and no assistance)
Key exclusion criteria
1. Consciousness disorder
2. Severe aphasia and/or severe cognitive dysfunction
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyomi Yoshioka |
Organization
Meisei university
Division name
Department of Design
Zip code
Address
2-1-1 Hodokubo, Hino, Tokyo
TEL
042-591-5111
kiyomi.yoshioka@design.meisei-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Miyasaka |
Organization
Fujita Health University Nanakuri Memorial Hospital
Division name
Division of Rehabilitation
Zip code
Address
424-1 Oodori, Tsu, Mie
TEL
059-252-2744
Homepage URL
hmiyasak@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Department of Design, Meisei university
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
Address
Tel
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
| 2017 | Year | 06 | Month | 26 | 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
| 2017 | Year | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 26 | Day |
Last modified on
| 2017 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030223
