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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?

Parkinson's Disease

Neurogenic Orthostatic Hypotension in Parkinson's Disease

Study Interventions

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

Device:Placebo binder

Study Arms

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

Study Status

Completed

Start Date: May 2013

Completed Date: May 2014

Phase: Phase 2

Type: Interventional

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01971008

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.

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