UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000022160
Receipt No. R000025538
Scientific Title Effect of illusory kinesthesia by vibratory tendon stimulation on patients after surgery for distal radius fractures
Date of disclosure of the study information 2016/05/01
Last modified on 2017/11/02

* 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 Effect of illusory kinesthesia by vibratory tendon stimulation on patients after surgery for distal radius fractures
Acronym Effect of illusory kinesthesia on patients after surgery
Scientific Title Effect of illusory kinesthesia by vibratory tendon stimulation on patients after surgery for distal radius fractures
Scientific Title:Acronym Effect of illusory kinesthesia on patients after surgery
Region
Japan

Condition
Condition distal radius fractures
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigated the effects of inducing an illusion of motion by tendon vibration on sensory and emotional aspects of pain, the activities of daily living and range of motion in patients with fractures of the distal radius.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pain at res
pain during movement
the Patient-Rated Wrist Evaluation
Key secondary outcomes the Pain Catastrophizing Scale
the Hospital Anxiety and Depression Scale
range of motion

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 illusory kinesthesia by tendon vibration
Interventions/Control_2 non illusory kinethesia
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
50 years-old <
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria distal radius fractures
Key exclusion criteria Patients were excluded if they had (1) severe chronic uncontrolled pain at a site other than the surgical wrist before the surgery (n = 4), or (2) stroke or other central nervous system disorders (n = 2).
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryota Imai
Organization Kawachi General Hospital
Division name Department of Rehabilitation
Zip code
Address 1-31 Yokomakura, Higashiosaka-cityOsaka 578-0954, Japan
TEL 072-965-0731
Email ryo7891@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Ryota Imai
Organization Kawachi General Hospital
Division name Department of Rehabilitation
Zip code
Address 1-31 Yokomakura, Higashiosaka-cityOsaka 578-0954, Japan
TEL 072-965-0731
Homepage URL
Email ryo7891@gmail.com

Sponsor
Institute Kawachi General Hospital
Department of Rehabilitation
Institute
Department

Funding Source
Organization nothing
Organization
Division
Category of Funding Organization Other
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 河内総合病院(大阪府)

Other administrative information
Date of disclosure of the study information
2016 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially 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 Main results already published
Date of protocol fixation
2014 Year 01 Month 17 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 20 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 05 Month 01 Day
Last modified on
2017 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025538

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.