UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040291 |
|---|---|
| Receipt number | R000045967 |
| Scientific Title | Effects of motion illusion on hand performance recovery by combined use of tendon vibration stimulation and visual stimulation in patients after distal radius fracture |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2023/11/06 08:15:18 |
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Basic information
Public title
Effects of motion illusion on hand performance recovery by combined use of tendon vibration stimulation and visual stimulation in patients after distal radius fracture
Acronym
Effects of motion illusion by combined use of tendon vibration and visual stimulation in patients after distal radius fracture
Scientific Title
Effects of motion illusion on hand performance recovery by combined use of tendon vibration stimulation and visual stimulation in patients after distal radius fracture
Scientific Title:Acronym
Effects of motion illusion by combined use of tendon vibration stimulation and visual stimulation in patients after distal radius fracture
Region
| Japan |
Condition
Condition
Distal radius fractures
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of new treatment method for patients after distal radius fracture
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Hand performance from the day after surgery to 12 weeks after surgery (Disabilities of the arm, shoulder, and hand)
Key secondary outcomes
Range of motion from 1weeks to 12weeks after sergery.
Grip strength from 6weeks to 12weeks after sergery.
Pain (VAS) from the day after surgery to 1weeksafter sergery.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Motion illusion induced by tendon vibration stimulation and image observation.
Using a handy massager for vibration stimulation, the extensor tendons of the hand are stimulated with vibration of 70-80Hz. A virtual reality system is used for image observation, and the image in which the wrist joint bends is observed in synchronization with the vibration stimulus.
Perform 3 sets of 30 seconds of stimulation and 10 seconds of rest. Period from the day after surgery to 1 week after surgery
Interventions/Control_2
Motion illusion induced by tendon vibration stimulation.
Perform 3 sets of 30 seconds of stimulation and 10 seconds of rest. Period from the day after surgery to 1 week after surgery
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
An adult treated by surgical treatment for distal radius fracture
Key exclusion criteria
Patients with severe upper limb complications such as fractures and nerve damage. Patients with impaired cognitive function
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Daichi |
| Middle name | |
| Last name | Narita |
Organization
Saitama prefectural university
Division name
Rehabilitation sciences course of health, medicine and welfare
Zip code
343-8540
Address
Sannomiya 820, Koshigaya city, Saitama
TEL
0427616020
nd0916ot@gmail.com
Public contact
Name of contact person
| 1st name | Daichi |
| Middle name | |
| Last name | Narita |
Organization
Sagamihara kyodo hospital
Division name
Rehabilitation
Zip code
2525188
Address
4-3-1, Hashimotodai, Midori ward, Kanagawa
TEL
0427616020
Homepage URL
nd0916ot@gmail.com
Sponsor or person
Institute
Saitama prefectural university
Institute
Department
Personal name
Funding Source
Organization
Saitama prefectural university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama prefectural university
Address
Sannomiya 820, Koshigaya city, Saitama
Tel
0489710500
nd0916ot@gmail.com
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
| 2020 | Year | 06 | Month | 01 | 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
15
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 | 08 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 02 | Day |
Last modified on
| 2023 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045967
