invalidating arm tremor trembling hands
Conditions
Interventions
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.
Sponsors
Reinier de Graaf Groep
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed