Abdominal Binder to Treat Orthostatic Hypotension (OH) in Parkinson's Disease (PD)
NCT ID: NCT01971008
Last Updated: 2023-03-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
15 participants
INTERVENTIONAL
2013-05-31
2014-05-31
Brief Summary
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Detailed Description
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Secondarily, we investigated the effects of an elastic abdominal binder on symptoms of orthostatic hypotension in daily living in a 4-weeks open-label follow-up.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Elastic abdominal binder, then placebo binder
Patients in this arm will be invited to wear an elastic abdominal binder ("Abdosyncro" Abdominalbandage, Syncro Med GmbH) for 2 hours on day 1 and a placebo binder ("Clima Care" Body warmer, Bort Medical) for 2 hours on day 3, after wash-out on day 2
Elastic abdominal binder
Placebo binder, then elastic abdominal binder
Patients in this arm will be invited to wear a placebo binder ("Clima Care" Body warmer, Bort Medical) for 2 hours on day 1 and an elastic abdominal binder ("Abdosyncro" Abdominalbandage, Syncro Med GmbH) for 2 hours on day 3, after wash-out on day 2
Placebo binder
Interventions
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Elastic abdominal binder
Placebo binder
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hoehn \& Yahr stadium \< or = 4
* Age: 40-90
* Laboratory confirmed neurogenic orthostatic hypotension (NOH)
* Stable pharmacological therapy in the last 6 weeks
* Full legal competence
Exclusion Criteria
* Untreated diabetes mellitus with clinical features of peripheral neuropathy
* Major cardiac diseases (ischemic, structural, arrhythmias)
* Evidence of varices (venous insufficiency stage \> or = C2, "varicose veins")
* Known or suspected pregnancy
* Breast feeding
40 Years
90 Years
ALL
No
Sponsors
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Medical University Innsbruck
OTHER
Responsible Party
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Klaus Seppi, MD
Univ. Prof. Dr.
Principal Investigators
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Klaus Seppi, Univ. Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology - Medical University Innsbruck
Locations
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Department of Neurology - Medical University Innsbruck
Innsbruck, Tyrol, Austria
Countries
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References
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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(0 3):S42-80. doi: 10.1002/mds.23884.
Ferreira JJ, Katzenschlager R, Bloem BR, Bonuccelli U, Burn D, Deuschl G, Dietrichs E, Fabbrini G, Friedman A, Kanovsky P, Kostic V, Nieuwboer A, Odin P, Poewe W, Rascol O, Sampaio C, Schupbach M, Tolosa E, Trenkwalder C, Schapira A, Berardelli A, Oertel WH. Summary of the recommendations of the EFNS/MDS-ES review on therapeutic management of Parkinson's disease. Eur J Neurol. 2013 Jan;20(1):5-15. doi: 10.1111/j.1468-1331.2012.03866.x.
Zesiewicz TA, Sullivan KL, Arnulf I, Chaudhuri KR, Morgan JC, Gronseth GS, Miyasaki J, Iverson DJ, Weiner WJ; Quality Standards Subcommittee of the American Academy of Neurology. Practice Parameter: treatment of nonmotor symptoms of Parkinson disease [RETIRED]: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2010 Mar 16;74(11):924-31. doi: 10.1212/WNL.0b013e3181d55f24.
Related Links
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Coordination center for clinical studies of the Medical University Innsbruck
Other Identifiers
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ABOHP
Identifier Type: -
Identifier Source: org_study_id
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