The primary aim of this research is:- To investigate the effect of the STIL orthosis on the tremor severity and amplitude in patients with forearm tremor.Secondary goals of this research are:- Assess patient satisfaction with orthosis efficacy and…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quantification of tremor severity will be based on the TETRAS scale, from which
7 tasks (postural out-stretched arms, postural wingbeat, finger-to-nose,
eating, drinking, pouring, writing) are selected that justly represent the
obstruction that ET patients experience in daily life.
A TETRAS score is rated on the baseline, sham and intervention conditions.
Combining the 7 tasks from the TETRAS scale, a maximum scoring of 28 points can
be achieved per condition. The expectation is that orthosis will reduce TETRAS
score by at least on categorial measure (e.g. from severe to moderate).
Quantification of tremor amplitude will be based on movement data from an
Inertial Measurement Unit (IMU). Again the same 7 tasks (postural out-stretched
arms, postural wingbeat, finger-to-nose, eating, drinking, pouring, writing)
are used to compare baseline, sham and intervention conditions.
A measure for overall tremor amplitude is calculated per test subject, for
every selected TETRAS task. The expectation is that the orthosis reduces tremor
amplitude by 60% between baseline and intervention.
See Chapter 7 of the Clinical Investigation Plan for more information.
Secondary outcome
The secondary outcome measure, patient satisfaction, will be scored to test
patient satisfaction with respect to comfort and usability of the orthosis with
the Dutch Quebec User Evaluation of Satisfaction with Assistive Technology
(D-QUEST).
This questionnaire consists of 8 questions about the device itself and 5
questions about the manufacturer's service. Only the part about the device
itself will be questioned.
Satisfaction is measured on a scale of 1-5, ranging from 'not at all satisfied'
to 'very satisfied'. Additional questions, posed by STIL, will be asked to
further investigate comfort and usability.
The other secondary outcome measure is intended to list the adverse events
reported by the patients themselves (from D-QUEST) and from the adverse event
forms that the investigator will fill out. This will provide a basis from which
safety of the device can be deduced.
Health related quality of life will be assessed at the intervention, in order
to correlate this to the effect on patient satisfaction.
See Chapter 7 of the Clinical Investigation Plan for more information.
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 STIL anti-tremor orthosis is developed; a wearable medical device
that suppresses the tremor by adding artificial (passive) damping to the joints
in the forearm. This orthosis will be tested on patients to investigate the
effectiveness and comfort of the device. It is hypothesized that orthosis
reduces tremor by more than 60%.
Study objective
The primary aim of this research is:
- To investigate the effect of the STIL orthosis on the tremor severity and
amplitude in patients with forearm tremor.
Secondary goals of this research are:
- Assess patient satisfaction with orthosis efficacy and comfort
Health related quality of life will also be assessed.
See Chapter 2 of the Clinical Investigation Plan for more information.
Study design
Single blind randomized crossover study, comparing a baseline with an
interventional orthosis and a sham orthosis.
See Chapter 3 of the Clinical Investigation Plan for more information.
Intervention
The STIL anti-tremor orthosis suppresses the tremor in the forearm. The sham
orthosis will only have weight effects.
See Chapter 7 of the Clinical Investigation Plan for more information.
Study burden and risks
The patients will wear the passive, non-invasive orthosis for a maximum of 60
minutes at a time.
Based on the Benefit-Risk analysis, the risks associated with this research are
estimated to be small, but the (indirect) benefits for this patient group are
very high when the product is available.
See IMDD, Appendix 5 for more information.
Reinier de graafweg 5
Delft 2625 AD
NL
Reinier de graafweg 5
Delft 2625 AD
NL
Listed location countries
Age
Inclusion criteria
- Diagnosed with Essential Tremor
- Significant disability due to forearm tremor, retrieved from Bain and Findley
ADL score (>30)
- Tremor severity score >13 on subset of TETRAS scale
- Dominant wrist flexion/extension and forearm pronation/supination tremor
- > 18 years old
Exclusion criteria
• Dominant shoulder internal/external rotation tremor
• Dominant elbow flexion/extension tremor
• Excessive alcohol consumption, as defined in the GGZ guidelines on alcohol
use 21
• Previous or planned Deep Brain Stimulation (DBS) at time of study enrollment
that interferes with testing.
• Previous or planned thalamotomy procedure, including stereotactic
thalamotomy, gamma knife radio surgical thalamotomy, and focused ultrasound for
the treatment of tremor at time of study enrollment that interferes with
testing.
• Change in medications related to tremor disorder in the 30 days prior to
study enrollment
• Swollen, infected, inflamed areas, or skin eruptions, open wounds, or
cancerous lesions of skin on the forearm or hand that would interfere with
wearing the orthosis during the clinical investigation.
• Peripheral neuropathy affecting the tested upper extremity (e.g. Carpal
tunnel syndrome)
• The suspicion or confirmation that head tremor may cause impairment in
performing ADL tasks
• Diagnosed Parkinson*s disease, this includes presence of parkinsonian features
• Diagnosed functional tremor
• Diagnosed physiologic tremor
• Diagnosed cerebellar tremor
• Diagnosed Multiple Sclerosis (MS)
• Diagnosed ataxia
• Patients with an amputation of one or both upper extremities.
• Subjects with a restricted movement or restricted muscle function in the arm
and or hand (e.g. contractures)
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL79108.000.21 |