UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061163 |
|---|---|
| Receipt number | R000068330 |
| Scientific Title | Verification of the Clinical Feasibility and Preliminary Effects on Early Functional Recovery of a Combined Exercise Observation and Vibration Stimulation Device Aimed at Promoting Early Recovery in Patients After Distal Radius Fracture Surgery |
| Date of disclosure of the study information | 2026/04/15 |
| Last modified on | 2026/04/05 19:17:18 |
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Basic information
Public title
Verification of the Clinical Feasibility and Preliminary Effects on Early Functional Recovery of a Combined Exercise Observation and Vibration Stimulation Device Aimed at Promoting Early Recovery in Patients After Distal Radius Fracture Surgery
Acronym
Verification of the Clinical Feasibility and Preliminary Effects on Early Functional Recovery of a Combined Exercise Observation and Vibration Stimulation Device Aimed at Promoting Early Recovery in Patients After Distal Radius Fracture Surgery
Scientific Title
Verification of the Clinical Feasibility and Preliminary Effects on Early Functional Recovery of a Combined Exercise Observation and Vibration Stimulation Device Aimed at Promoting Early Recovery in Patients After Distal Radius Fracture Surgery
Scientific Title:Acronym
Verification of the Clinical Feasibility and Preliminary Effects on Early Functional Recovery of a Combined Exercise Observation and Vibration Stimulation Device Aimed at Promoting Early Recovery in Patients After Distal Radius Fracture Surgery
Region
| Japan |
Condition
Condition
Distal radius fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
A Preliminary Study on the Clinical Feasibility and Early Functional Recovery Effects of the Ghost System Combining Vibration Stimulation and Kinesthetic Illusion in Patients After Distal Radius Fracture Surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Device Evaluation Assessed using an 8 item Numeric Rating Scale NRS
Participants subjectively rated items on an 11 point scale 0 to 10
Data collected on the first day of intervention and at completion
Items Satisfaction with training content Fatigue Discomfort during wear or training Usefulness Necessity Continuity Acceptability
2. Visual Analog Scale VAS
Before and after training participants are asked to use a VAS scale 0 to 100 mm to mark with a pen their current subjective pain intensity
3. Measurement of Wrist and Forearm Range of Motion Equipment used Goniometer
Measurements of wrist flexion extension pronation supination and forearm pronation and supination will be taken before and after training
Key secondary outcomes
Upper Limb Function Assessment DASH
Patients complete the Disability of the Arm Shoulder and Hand questionnaire before training
Wrist Specific Function and Pain Assessment PRWE
Patients complete the Patient Rated Wrist Evaluation questionnaire before training
Upper Limb Functional Assessment HANDS 20
Patients complete the 20 item functional and social assessment questionnaire after training
Quality of Life Assessment EQ 5D 5L
Patients answer 5 questions on a 5 point scale before training
Body Ownership and Illusion Questionnaire Longo 2008 based
Administered at the start and end of training
A 9 item Numeric Rating Scale 0 to 10 evaluates illusion vividness and duration
Setup Time of Modified Ghost System
At the first session therapists explain setup procedures
From the second session participants perform setup and therapists measure time with a stopwatch
Errors and corrective instructions are recorded
Adverse Event Monitoring
Adverse events from start to end of intervention including pain worsening fracture worsening skin problems dizziness and nausea are recorded
Items include onset date event type details response causal relationship and discontinuation
Device related incidents such as malfunctions and errors are also recorded with date details and response
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Equipment Used
Wristband Vibrator Bioethics Approval Number Saitama 202509
A vibrator motor DC5V USB charger vibrator motor speed adjustable 3000 4500 RPM is inserted into the wristband Reebok Sports Wristband Short, product size 8L 8W 1.5H.
Positioned so the vibrator motor sits 10mm from the top of the wristband. Attach Velcro to the wristband.
Visual Stimulus Induction Device
Mount iPad monitor on rack dimensions Width 30 Height 14 Depth 21.5 cm.
Intervention Preparation
Prepare videos showing the subject with wrists flexed.
Cross both hands with the thumb of the non-injured hand facing upward, palms flat on the ground. Prepare two videos each for left and right wrist flexion.
Videos show the wrist flexing left over 5 seconds and returning to neutral over 1 second. Perform the same sequence on the opposite side using the same timing. Total time 36 seconds.
Place the visual stimulus delivery device 15 cm away from the front edge of the table.
The subject wears a wristband-type vibrator positioned so its upper part rests on the proximal wrist crease of the unaffected side, with the vibrator contacting the extensor carpi ulnaris tendon.
Intervention Method
Apply vibratory stimulation to the extensor carpi radialis tendon using a wristband-type vibrator for 36 seconds. After 36 seconds, allow a 10-second rest period, then apply vibratory stimulation again for 36 seconds.
During the vibration stimulation, the participant moves their own hand in sync with the hand movements displayed on the iPad screen. The researcher verbally prompts the participant to mentally imagine their hand moving in the same way as the observed video.
This intervention is performed once daily in 3 sets.
Intervention Period
Training conducted for 1 to 8 weeks. Intervention once or twice per week.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who are 18 years of age or older at the time consent is obtained
2. Patients who have undergone surgery for a distal radius fracture
3. Patients currently attending an orthopedic outpatient clinic and for whom rehabilitation has been prescribed
4. Patients who have consented to the use of the modified Ghost system
5. Patients who are able to provide informed consent to participate in this study
Key exclusion criteria
1. Patients with distal radius fractures who experienced a delay between injury and surgery and have developed joint contractures
2. Patients suspected of having moderate cognitive impairment, as indicated by a Mini-Mental State Examination (MMSE) score of 20 or lower
3. Patients who have had a distal radius fracture surgery more than 10 days ago
4. Patients in a life-threatening medical condition
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kamijo |
| Middle name | |
| Last name | Giitiro |
Organization
Dokkyo Medical University Saitama Medical Center
Division name
Department of Rehabilitation
Zip code
343-8555
Address
2-1-50 Minamikosigaya, Koshigayashi, Saitama Prefecture
TEL
048-965-1111
a-kanou@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Akito |
| Middle name | |
| Last name | Kano |
Organization
Dokkyo Medical University Saitama Medical Center
Division name
Department of Rehabilitation
Zip code
343-8555
Address
2-1-50 Minamikosigaya, Koshigayashi, Saitama Prefecture
TEL
048-965-1111
Homepage URL
a-kanou@dokkyomed.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
None
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
Dokkyo Medical University Saitama Medical Center
Address
2-1-50 Minamikosigaya, Koshigayashi, Saitama Prefecture
Tel
048-965-1111
a-kanou@dokkyomed.ac.jp
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
| 2026 | Year | 04 | Month | 15 | 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
| 2026 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 04 | Month | 05 | Day |
Last modified on
| 2026 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068330
