Parkinson DiseaseNCT07134634
Effect of a Vibrating Therapy Ball on Tremor and Daily Activities in Patients With Different Tremor Syndroms
An observational study of Parkinson Disease, run by Parkinson's Clinic in Beelitz-Heilstatten at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- tremor device
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 8 Nov 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with different tremor syndroms
Who may be able to join
- diagnosis of tremor
- ability to complete the tests
- no cognitive deficits relevant to everyday life
Who cannot join
- cognitive deficits relevant to everyday life that influence therapy
- pronounced dystonia, dyskinesia
- Pregnancy
- Acute thrombotic process (myocardial infarction, (acute vascular constriction)
- Implants in activated regions of the body (e.g.artificial joints)
- Acute inflammation of the locomotor system active arthrosis or arthropathy e.g. acute inflammationor swelling of joints
Show all 12Show fewer
- 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
- Post-surgery wounds and fresh wounds in activated regions of the body or incomplete wound healing
- Rheumatoid arthritis
- Epilepsy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
ParkinsonBeelitzHeilstaetten
Beelitz, Brandenburg, 14547
Doreen Gruber, MD, +493320422781, doreen.gruber@kliniken-beelitz.de
About this study
Official title: Effekt Eines Vibrierenden Therapieballs Auf Den Tremor Und Alltagsaktivitäten Bei PatientInnen Mit Verschiedenen Tremorsyndromen
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.
Read more
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).
- Conditions
- Parkinson Disease
- Being tested
- tremor device
- Keywords
- Tremor
- Medical subject headings
- Parkinson Disease, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tremor deviceDevice
tremor ball on versus tremor ball off
| Study group | Role | What they receive |
|---|---|---|
| tremor cohort | Not described Receives: Device: tremor device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start8 Nov 2024
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parkinson's Clinic in Beelitz-Heilstatten
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. med.habil. Doreen Gruber, Parkinson's Clinic in Beelitz-Heilstatten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134634
- Sponsor's protocol ID
- 2024-103-BO-ff
- Status last verified
- Aug 2025
- First submitted
- 5 Mar 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following the data publication, IPD will be available from the coresponding author upon reasonable request.
Publications
Haubenberger D, Hallett M. Essential Tremor. N Engl J Med. 2018 May 10;378(19):1802-1810. doi: 10.1056/NEJMcp1707928. No abstract available.
PubMed 29742376Abramavicius S, Venslauskas M, Vaitkus A, Gudziunas V, Laucius O, Stankevicius E. Local Vibrational Therapy for Essential Tremor Reduction: A Clinical Study. Medicina (Kaunas). 2020 Oct 21;56(10):552. doi: 10.3390/medicina56100552.
PubMed 33096872
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effekt Eines Vibrierenden Therapieballs Auf Den Tremor Und Alltagsaktivitäten Bei PatientInnen Mit Verschiedenen Tremorsyndromen
- ClinicalTrials.gov ID
- NCT07134634
- Acronym / sponsor ID
- 2024-103-BO-ff
- Conditions
- Parkinson Disease
- Keywords
- Tremor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Parkinson's Clinic in Beelitz-HeilstattenUniversity, hospital or other
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tremor cohort | – | Device: tremor device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with different tremor syndroms
Key inclusion criteria (3 listed)
- diagnosis of tremor
- ability to complete the tests
- no cognitive deficits relevant to everyday life
Key exclusion criteria (12 listed)
- cognitive deficits relevant to everyday life that influence therapy
- pronounced dystonia, dyskinesia
- Pregnancy
- Acute thrombotic process (myocardial infarction, (acute vascular constriction)
- Implants in activated regions of the body (e.g.artificial joints)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tremor devicetremor ball on versus tremor ball off | Device | tremor cohort |
Primary outcome
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:
Time frame: 2 years
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Results publication: PubMed 29742376Haubenberger D, Hallett M. Essential Tremor. N Engl J Med. 2018 May 10;378(19):1802-1810. doi: 10.1056/NEJMcp1707928. No abstract available.
- Results publication: PubMed 33096872Abramavicius S, Venslauskas M, Vaitkus A, Gudziunas V, Laucius O, Stankevicius E. Local Vibrational Therapy for Essential Tremor Reduction: A Clinical Study. Medicina (Kaunas). 2020 Oct 21;56(10):552. doi: 10.3390/medicina56100552.
- Individual participant dataSharing planned: Yes. Following the data publication, IPD will be available from the coresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Parkinson's Clinic in Beelitz-Heilstatten at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gruber, MD (+493320422781, doreen.gruber@kliniken-beelitz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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: (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07134634, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.