UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017389 |
|---|---|
| Receipt number | R000020119 |
| Scientific Title | Effect of high-intensity pulse irradiation with linear polarized near infrared rays and stretching on muscle tone in patients with cerebrovascular disease |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2017/09/15 10:13:02 |
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Basic information
Public title
Effect of high-intensity pulse irradiation with linear polarized near infrared rays and stretching on muscle tone in patients with cerebrovascular disease
Acronym
Effect of HI-LPNR and stretching on muscle tone
Scientific Title
Effect of high-intensity pulse irradiation with linear polarized near infrared rays and stretching on muscle tone in patients with cerebrovascular disease
Scientific Title:Acronym
Effect of HI-LPNR and stretching on muscle tone
Region
| Japan |
Condition
Condition
cerebrovascular disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of high-intensity pulse irradiation with linear polarized near-infrared ray and stretching on muscle tone in patients with cerebrovascular disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Change of passive range of motion of ankle dorsiflexion.
2.Change of passive resistive joint torque of ankle dorsiflexion.
3.Ankle plantar flexors tone scale
Key secondary outcomes
Adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
HI-LPNR irradiation group
Interventions/Control_2
Stretching group
Interventions/Control_3
combination group (The group was a combination of Hi-LPNR irradiation and stretching)
Interventions/Control_4
Control group
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. a score of >=1 on at least one item of the Ankle Plantar Flexors Tone Scale.
2. cerebrovascular disease
Key exclusion criteria
1. previous surgical treatment or drug therapy (whether administered orally or by injection) for hypertonia.
2. limited range of motion of the ankle joint on the paretic side with a cause other than hypertonia.
3. presence of pain or another factor that could influence measurement.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Takeuchi |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Health care
Zip code
Address
501 Nakaoruicho, Takasaki City, Gunma, Japan
TEL
027-352-1291
ntakeuchi@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Takeuchi |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Health care
Zip code
Address
501 Nakaoruicho, Takasaki City, Gunma, Japan
TEL
027-352-1291
Homepage URL
ntakeuchi@takasaki-u.ac.jp
Sponsor or person
Institute
Faculty of Health care, Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI grant-in-aid for young scientists B
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
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
本庄総合病院(埼玉県)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 19 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 19 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 19 | Day |
Date analysis concluded
| 2015 | Year | 05 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 01 | Day |
Last modified on
| 2017 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020119
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
