Studien

ESRA:

The planned study is titled “Evaluation of self-conducted remote motor assessment” (ESRA) and will be conducted in collaboration with the Department of Neurology at Dresden University Hospital. The contact person here is Prof. Dr. Falkenburger.

The study serves to prove the positive care effect of a software (Amsa, Motognosis GmbH, Germany) for the measurement of motor symptoms by patients with Parkinson’s disease in their home environment. The data collected will serve as symptom monitoring, and can be used by professionals to identify symptoms, detect side effects, and adjust therapy and medications. The primary endpoints of the study is intra-individual change as well as inter-group comparison of changes in the Movement Disorder Society Unified Parkinson’s Disease Rating Scale score Part III for motor symptoms. The score is scientifically established and current gold standard for eliciting motor symptom severity in individuals with PD (Goetz, et al., 2008) and is sensitive to change (Goetz, et al., 2008; Horváth, et al., 2015).

The study is a longitudinal randomized controlled trial with two parallel groups. Two clinical measurement time points will be collected 26 weeks apart (longitudinal). Study participants will be randomly assigned to two groups (randomized with two parallel groups), an intervention group receiving the Amsa system for 24 weeks and routine care and a control group receiving just the routine care . Clinical data for both groups will be collected from the treating neurologists (controlled). To obtain a study power of 80% with a two-sided significance level of 0.05 for the primary question, at least 82 subjects per group will be included assuming a dropout rate of 15%. This results in a sample size of at least 164 subjects for the study.

Would you like to participate in the study or have additional questions? Contact us at contact@motognosis.com