Parkinson's Disease | Abdominal Binder to Treat Orthostatic Hypotension (OH) in Parkinson's Disease (PD)
Parkinson's Disease research study
What is the primary objective of this study?
The purpose of the present study is to determine whether the use of an abdominal binder is effective in the non-pharmacological management of orthostatic hypotension in patients suffering from Parkinson's disease
Who is eligible to participate?
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Neurogenic Orthostatic Hypotension in Parkinson's Disease
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:Elastic abdominal binder
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Placebo binderPatients in this arm will be invited to wear a placebo binder ("Clima Care" Body warmer, Bort Medical) for 2 hours
Elastic abdominal binderPatients in this arm will be invited to wear an elastic abdominal binder ("Abdosyncro" Abdominalbandage, Syncro Med GmbH) for 2 hours
Start Date: May 2013
Completed Date: May 2014
Phase: Phase 2
Primary Outcome: Effect of an elastic abdominal binder versus a placebo binder on mean blood pressure (mmHg) after 3 minutes of orthostatic challenge (on passive tilting) with respect to baseline in Parkinson's disease patients with neurogenic orthostatic hypotension
Secondary Outcome: Effect of an elastic abdominal binder versus a placebo binder on systolic blood pressure (mmHg) after 3 minutes of orthostatic challenge with respect to baseline in Parkinson's disease patients with neurogenic orthostatic hypotension
Study sponsors, principal investigator, and references
Principal Investigator: Klaus Seppi, Univ. Prof. Dr.
Lead Sponsor: Medical University Innsbruck
Seppi K, Weintraub D, Coelho M, Perez-Lloret S, Fox SH, Katzenschlager R, Hametner EM, Poewe W, Rascol O, Goetz CG, Sampaio C. The Movement Disorder Society Evidence-Based Medicine Review Update: Treatments for the non-motor symptoms of Parkinson's disease. Mov Disord. 2011 Oct;26 Suppl 3:S42-80. doi: 10.1002/mds.23884. Review.