NCT07134634 Effect of a Vibrating Therapy Ball on Tremor and Daily Activities in Patients With Different Tremor Syndroms
| NCT ID | NCT07134634 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Parkinson's Clinic in Beelitz-Heilstatten |
| Condition | Parkinson Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-11-08 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-11-08 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07134634 clinical trial?
This trial is open to participants of all sexes, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07134634 currently recruiting?
Yes, NCT07134634 is actively recruiting participants. Contact the research team at doreen.gruber@kliniken-beelitz.de for enrollment information.
Where is the NCT07134634 trial being conducted?
This trial is being conducted at Beelitz, Germany.
Who is sponsoring the NCT07134634 clinical trial?
NCT07134634 is sponsored by Parkinson's Clinic in Beelitz-Heilstatten. The trial plans to enroll 60 participants.
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