The effect of the STIL anti-tremor orthosis on reduction of forearm tremor in Essential Tremor patients - a single blind randomized crossover study

Completed

• Conditions: trembling hands; 10028037; invalidating arm tremor

• Registration Number: NL-OMON51742
• Lead Sponsor: Reinier de Graaf Groep

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified