Customized vibrating therapy ball to reduce hand tremor in Parkinson's disease
Effekt Eines Vibrierenden Therapieballs Auf Den Tremor Und Alltagsaktivitäten Bei PatientInnen Mit Verschiedenen Tremorsyndromen
This project will test a personalized vibrating therapy ball to see if it temporarily reduces hand tremor and helps daily activities in people with Parkinson's disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Sex | All |
| Sponsor | Parkinson's Clinic in Beelitz-Heilstatten Academic / other |
| Locations | 1 site (Beelitz, Brandenburg) |
| Trial ID | NCT07134634 on ClinicalTrials.gov |
What this trial studies
This observational project uses a CE-certified portable vibrating device (VILIM) that is customized to each patient during a training phase and intended for home or clinic use. Participants will have tremor and everyday-task performance measured before and after device use to document any temporary tremor reduction and functional benefit. The manufacturer reports up to 50% tremor reduction lasting up to four hours, and the study aims to document these effects and monitor safety in real-world use. Eligible participants must be able to complete assessments and have no relevant cognitive deficits, while people with pronounced dystonia, dyskinesia, active inflammation, certain implants, epilepsy, pregnancy, recent wounds or fractures are excluded.
Who should consider this trial
Good fit: Adults with a diagnosed tremor (for example from Parkinson's disease) who can complete simple tests and do not have significant cognitive impairment are ideal candidates.
Not a fit: People with pronounced dystonia or dyskinesia, active inflammatory or wound conditions, certain implants in treated regions, epilepsy, pregnancy, or other listed exclusions are unlikely to benefit from this device.
Why it matters
Potential benefit: If successful, the vibrating ball could temporarily reduce hand tremor for several hours and make everyday tasks like eating and dressing easier.
How similar studies have performed: Some small or preliminary reports of sensory or vibration-based approaches have shown temporary tremor reductions, but large, confirmatory studies are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. diagnosis of tremor
2. ability to complete the tests
3. no cognitive deficits relevant to everyday life
Exclusion Criteria:
1. cognitive deficits relevant to everyday life that influence therapy
2. pronounced dystonia, dyskinesia
3. Pregnancy
4. Acute thrombotic process (myocardial infarction, (acute vascular constriction)
5. Implants in activated regions of the body (e.g.artificial joints)
6. Acute inflammation of the locomotor system active arthrosis or arthropathy e.g. acute inflammationor swelling of joints
* Acute tendinopathy in activated regions of the body (acute tendon inflammation)
• Acute desmopathy (acute problems at the intervertebral disc)
* Fresh fractures in activated regions of the body
7. Post-surgery wounds and fresh wounds in activated regions of the body or incomplete wound healing
8. Rheumatoid arthritis
9. Epilepsy.
Where this trial is running
Beelitz, Brandenburg
- ParkinsonBeelitzHeilstaetten — Beelitz, Brandenburg, Germany (Recruiting)
Study contacts
- Study coordinator: Gruber, MD
- Email: doreen.gruber@kliniken-beelitz.de
- Phone: +493320422781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.