NCT07134634 Effect of a Vibrating Therapy Ball on Tremor and Daily Activities in Patients With Different Tremor Syndroms

Trial Parameters

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Brief Summary

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).

Eligibility 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.

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