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 range50 Years – 85 Years
SexALL
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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…
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.