UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020515 |
|---|---|
| Receipt number | R000023685 |
| Scientific Title | Anti-spastic effect of wrist extension orthosis in post-stroke patients: A pilot study |
| Date of disclosure of the study information | 2016/01/10 |
| Last modified on | 2016/01/30 23:09:22 |
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Basic information
Public title
Anti-spastic effect of wrist extension orthosis in post-stroke patients: A pilot study
Acronym
Anti-spastic effect of wrist extension orthosis in post-stroke patients
Scientific Title
Anti-spastic effect of wrist extension orthosis in post-stroke patients: A pilot study
Scientific Title:Acronym
Anti-spastic effect of wrist extension orthosis in post-stroke patients
Region
| Japan |
Condition
Condition
Post-stroke patients
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of wrist extension orthosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
modified Tardieu scale and modified Ashworth scale (MAS) at baseline and after 4-week intervention
Key secondary outcomes
Fugl-Meyer assessment (FMA), Brunnstrom recovery stage, passive range of motion (P-ROM), active range of motion (A-ROM), visual analogue scale VAS), functional independence measure (FIM)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention with the wrist extension orthosis is scheduled 6 hours/day, six times a week, for 4 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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
post-stroke patients with hemiplegia; more than 1 month after the onset of stroke and stable condition; Brunnstrom recovery stage of upper limb >III; pastic wrist and finger; imformed consent
Key exclusion criteria
severe higher brain dysfuncction and dementia, conscious disturbance; joint disformation of upper limb; severe sensory disturbance; severe skin disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuji Matsumoto |
Organization
Kagoshima University
Division name
Dept. of Rehabilitation
Zip code
Address
3930-7 Takachiho, Makizono-cho, Kirishima City
TEL
0995-78-2538
shushu@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuji Matsumoto |
Organization
Kagoshima University
Division name
Dept. of Rehabilitation
Zip code
Address
3930-7 Takachiho, Makizono-cho, Kirishima City
TEL
0995-78-2538
Homepage URL
shushu@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
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)
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
| 2016 | Year | 01 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 10 | Day |
Last modified on
| 2016 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023685
