Abdominal Binders to Treat Orthostatic Hypotension in Parkinsonian Syndromes (NCT04920552) | Clinical Trial Compass
UnknownNot Applicable
Abdominal Binders to Treat Orthostatic Hypotension in Parkinsonian Syndromes
Austria30 participantsStarted 2021-05-17
Plain-language summary
The purpose of the present clinical trial is to determine whether the use of an elastic abdominal binder is effective in the non-pharmacological management of symptomatic, neurogenic orthostatic hypotension (OH) in individuals suffering from Parkinson's disease (PD) or Parkinson variant multiple system atrophy (MSA-P).
Who can participate
Age range
50 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* diagnosis of possible or probable MSA-P (Gilman 2008) or clinically established PD (Postuma 2015);
* 50 to 85 years of age;
* laboratory-confirmed symptomatic (i.e. OHQ - OH Symptom Assessment item #1 ≥ 4), neurogenic OH at screening visit or previously diagnosed as such (i.e. neurogenic OH ratio \[≤ 0.492 Δ heart rate rise/systolic BP fall\] or missing BP overshoot at phase IV of Valsalva maneuver;
* stable medication schedule in the preceding 3 weeks;
* no infectious disease in the preceding 3 weeks;
* Hoehn \& Yahr stage ≤ 3;
* gait item of the Unified MSA Rating Scale (UMSARS) Part II or the Movement Disorder Society - Unified PD Rating Scale (MDS-UPDRS) Part III score \< 3;
* body sway item of the UMSARS II/MDS-UPDRS III score \< 3;
* arising from chair item of the UMSARS II/MDS-UPDRS III score \< 3;
* full legal capacity;
* written informed consent has been obtained.
Exclusion Criteria:
* participation in other interventional trials;
* prescribed and regular use of abdominal binders OR compression stockings for OH treatment;
* other major neurologic or psychiatric diseases which could influence OH or gait;
* untreated diabetes mellitus with clinical features of peripheral neuropathy;
* non-neurological causes of gait disorders;
* major cardiac diseases (ischemic, structural, arrhythmias);
* evidence of varices (venous insufficiency stage ≥ C2, "varicose veins");
* known abdominal aortic aneurism;
* indwelling catheterisation;
* recent surgery (3…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on mean BP change (mmHg) after 3rd minute of head-up tilt test with respect to baseline.
Timeframe: 3 days
Trial details
NCT IDNCT04920552
SponsorUniversitätsklinik für Neurologie, Innsbruck