Clinical Trial: 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 (Japan)

Tokyo, April 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061163) titled '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' on April 15.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - Other

Condition: Condition - Distal radius fracture Classification by malignancy - Others Genomic information - YES

Objective: 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

Intervention: 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.

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 Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 20 Day Anticipated trial start date - 2026 Year 04 Month 10 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068330

Disclaimer: Curated by HT Syndication.