An observational study in Parkinson Disease, sponsored by Parkinson's Clinic in Beelitz-Heilstatten. Recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2025-08-21.
Sponsored by Parkinson's Clinic in Beelitz-Heilstatten · Observational
Tremors, e.g. in patients with Parkinson's disease and essential tremor, are often pharmacoresistant, meaning that invasive treatment options such as deep brain stimulation are used at an early stage. Sufficient complementary non-pharmacological treatment alternatives do not yet exist. Patients with tremor are often severely restricted in their ability to carry out everyday activities and require support from relatives and carers, e.g. with food intake and hygiene measures.
The VILIM ball device is a CE-certified, non-invasive, portable physiotherapeutic aid. It is intended for use at home or in a professional setting as a mechanical vibration therapy device to temporarily reduce hand tremor.
With this vibrating therapy ball (VILIM tremor ball), which is customised to the patient's tremor during a training phase, should temporarily reduce tremor by up to 50%, according to the manufacturer. The effect can last up to 4 hours, so that patients should be able to carry out their everyday activities better, e.g. eating, writing, etc. (https://vilimed.com).
An initial study already reported a reduction in tremor in patients with Parkinson's disease and essential tremor. However, this study lacked a training phase, a control group and an examination of the effect on functions relevant to everyday life, meaning that reliable conclusions on the effect are only possible to a limited extent In this study, the influence of the portable physiotherapeutic therapy device (VILIM ball) on tremor in the upper extremity compared to an alternative therapy as a control condition in patients with Parkinson's tremor, essential tremor and other tremor syndromes will be investigated for the first time. The evaluation of the physician-associated scales will additionally be carried out by an independent physician in a single-blinded manner on the basis of video documentation.
The primary endpoint is a significant effect of the therapy ball on tremor, quantified and qualified using Clinical Global Impression Severity (CGI severity:
Assessment by doctor and patient) and validated disease-specific tremor scales: MDS-UPDRS IIl including the Tremor subscale, TETRAS between tremor ball therapy (Ball-On) alternative therapy (Ball-Off). Secondary endpoints include the effect of the therapy ball compared to the ball-off condition on tremor analysis data (e.g. frequency peak, amplitude) of an accelerometer, mini darts, writing tasks, specific tasks of daily life: e.g. bringing a spoon with liquid to the mouth, pouring water into a glass without losing the liquid and the success of the therapy using CGI improvement (doctor and patient).
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 60 is below the median of 96 across 1,085 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →This is the only study on the registry with Parkinson's Clinic in Beelitz-Heilstatten as lead sponsor.
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Patients with different tremor syndroms
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Exclusion Criteria:
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)
Device: tremor device
tremor ball on versus tremor ball off
The effect of the vibrating therapy ball on hand tremor will be assessed before and after use, comparing ball-on vs. ball-off. The following scores will be used:
Primary endpoints: * Change in Clinical Global Impression Severity (Assessment by physician and patient) after using the therapy ball (Score 0 to 7 pts., a lower score means better outcome) * Change in MDS-UPDRS part IIl (Score 0 - 132 pts., a lower score means a better outcome) * Change in 2 items of TETRAS Activities of Daily Living Subscale (Score 0 -8 pts., a lower score means a better outcome) Secondary endpoints: * Changes in the frequency of the tremor (in Hz) using an acceleromter. A lower value means a better outcome * Changes in amplitude of the tremor (in mm) using an accelerometer. A lower value means a better outcome * changes in 3 items of Fahn-Tolosa-Marin-Tremor-Rating-Scale (0-12 pts.). A lower score means a better outcome * Change in Clinical Global Impression-Improvment Scale (CGI-I), (0-7 pts., lower score means better outcome
Time frame: 2 years
Plan to share: Yes — Following the data publication, IPD will be available from the coresponding author upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: see above
Access criteria: see above
Started Nov 2024 (actual). Primary completion is estimated for Nov 2026, 24 months after the start.
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