Primary objective: - To evaluate the effect of the STIL brace on tremor amplitude in patients with forearm tremor. Secondary objectives: - To evaluate the effect of the STIL brace on patients* impressions of tremor severity.- To assess patient…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this study is tremor amplitude, measured with
accelerometry sensors with gyro on the hand and the arm. The tremor amplitude
will be compared over the three situations (without brace, with active brace
and with passive brace). We expect a tremor amplitude reduction of at least 50%
with brace suppression compared to the situation without brace.
Secondary outcome
Secondary outcomes are:
- Subjective severity of the tremor, measured with the Patient Global
Impression of Severity (PGI-S)
- Patient satisfaction with regards to the brace, measured with the Dutch
version of the Quebec User Evaluation of Satisfaction with Assistive Technology
(D-QUEST) and an extra questionnaire developed by STIL to get more specific
feedback on the brace.
Background summary
Tremor is the most common movement disorder. Forearm tremor affects fine fine
motor control and can therefore have a big functional impact, impairing daily
activities such as writing, drinking, or dressing. Current treatment
(medication and brain surgery) often do not have the desired effect and
side-effects are known. Nowadays, devices are known that target the symptoms
instead of the origin of the disorder. These devices make use of mechanical
suppression or muscle/nerve stimulation in order to reduce the tremor severity.
However, these devices are often task specific, bulky and awkward to wear and
restricting voluntary movement.
Therefore, the STIL brace is developed; a wrist brace that is easy to wear and
suppresses the tremor by producing an anti-vibration, without restricting
voluntary movements.This brace will be tested on patients to evaluate the
effect of the brace on tremor severity and to assess patient satisfaction. The
hypothesis is that the brace will suppress the tremor which will lead to a
tremor amplitude reduction of at least 50%.
Study objective
Primary objective:
- To evaluate the effect of the STIL brace on tremor amplitude in patients with
forearm tremor.
Secondary objectives:
- To evaluate the effect of the STIL brace on patients* impressions of tremor
severity.
- To assess patient satisfaction with regards to the usability and comfort of
the STIL brace.
Study design
Randomized double-blind crossover study.
Tremor severity will be measured in 3 situations: without brace (baseline),
with brace in active mode (intervention) and with brace in passive mode
(placebo). The order of the modes in which the brace functions, will be
randomly assigned by the computer. In passive mode, the brace sounds and looks
looks the same as in the active mode, but no vibrations are produced. In this
way the investigator nor the patient knows when the brace is on or off.
Intervention
The intervention is the STIL brace that suppresses the tremor in the active
mode. In this condition, different movements and postures are performed with
the hand/arm during which the tremor amplitude will be registered. This takes
about 10 minutes.
The placebo condition is when the STIL brace functions in passive mode. The
same procedure will be repeated as with the active brace while the tremor
amplitude is measured. The passive mode will be assessed to evaluate the effect
of the weight of the brace on tremor amplitude.
The order of the modes will be randomly assigned by a computer.
Study burden and risks
Based on the risk analysis that is performed, it can be expected that there are
minimal risks for the participants. The brace will be worn for a maximum of 30
minutes, the brace will only interact with the intact skin, patients are not at
high risk and precautionary measures are taken. In case the brace functions not
as expected, despite the safety measures, it can be detached directly.
Reinier de graafweg 5
Delft 2625 AD
NL
Reinier de graafweg 5
Delft 2625 AD
NL
Listed location countries
Age
Inclusion criteria
* Patients over 18 years old
* Competent and willing to sign informed consent
* Significant disability due to forearm tremor. (ADL score of 3 or above in one
of the upper limb items and a minimum subset score of 38 across all upper limb
items. Scored for the most affected hand with the Bain and Findley ADL scale)
Exclusion criteria
* Excessive alcohol consumption, as defined in the GGZ guidelines
* Implanted electrical medical device, such as a pacemaker, defibrillator, or
deep brain stimulator
* Previous thalamotomy procedure, including stereotactic thalamotomy, gamma
knife radio surgical thalamotomy, and focused ultrasound for the treatment of
tremor
* Change in medication in the 30 days prior to study enrollment
* Taking medication known to exacerbate tremor
* Suspected or diagnosed epilepsy
* Swollen, infected, inflamed areas, or skin eruptions, open wounds, or
cancerous lesions of skin at stimulation site.
* Peripheral neuropathy affecting the tested upper extremity (e.g. Carpal
tunnel syndrome)
* Presence of any other neurodegenerative diseases like multisystem atrophy,
progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's
disease.
* Patients diagnosed with a depression
* Patients with an amputation of one or both upper extremities.
* Subjects with a restricted movement of the arm and or hand (e.g.
contractures) or restricted muscle function
* Botulinum toxin injection for hand tremor within 6 months prior to study
enrollment
* Alcohol or caffeine consumption within 24 hours of study enrollment.
* Heavy physical training within 24 hours of study enrollment
* Subjects unable to communicate with the investigator and staff
* Subjects with illiteracy
* Pregnancy at time of study enrollment
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL69132.098.19 |