Distal radius fracture
Conditions
Interventions
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 Spor
Sponsors
Other
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactAkito Kano
Dokkyo Medical University Saitama Medical Center Department of Rehabilitation
Outcome results
None listed