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Abdominal Binders to Treat Orthostatic Hypotension in Parkinsonian Syndromes (ABOH-PS)

Primary Purpose

Parkinson Disease, Multiple System Atrophy, Parkinson Variant, Orthostatic; Hypotension, Neurogenic

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Elastic abdominal binder
Placebo binder
Sponsored by
Universitätsklinik für Neurologie, Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of possible or probable MSA-P (Gilman 2008) or clinically established PD (Postuma 2015);
  • 50 to 80 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 months) requiring anaesthesia;
  • known or suspected pregnancy;
  • breast-feeding female participants.

Sites / Locations

  • Medical University InnsbruckRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo binder first

Elastic abdominal binder first

Arm Description

Participants in this arm will wear the placebo comparator ("Clima Care" body warmer, Bort Medical GmbH) for 2 hours on treatment day-1 (i.e. Visit 1), followed by the active comparator ("ABDO-SYNCRO 3-BAHNIG" elastic abdominal binder, SYNCRO-MED GmbH) for 2 hours on treatment day-2 (i.e. Visit 2).

Participants in this arm will wear the active comparator ("ABDO-SYNCRO 3-BAHNIG" elastic abdominal binder, SYNCRO-MED GmbH) for 2 hours on treatment day-1 (i.e. Visit 1), followed by the placebo comparator ("Clima Care" body warmer, Bort Medical GmbH) for 2 hours on treatment day-2 (i.e. Visit 2).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on systolic BP change (mmHg) after 3rd minute of head-up tilt test with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on diastolic BP change (mmHg) after 3rd minute of head-up tilt test with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on mean BP change (mmHg) after 10th minute of head-up tilt test with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on systolic BP change (mmHg) after 10th minute of head-up tilt test with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on diastolic BP change (mmHg) after 10th minute of head-up tilt test with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute mean orthostatic BP value (mmHg) after 3rd minute of head-up tilt test with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute systolic orthostatic BP value (mmHg) after 3rd minute of head-up tilt test with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute diastolic orthostatic BP value (mmHg) after 3rd minute of head-up tilt test with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute mean orthostatic BP value (mmHg) after 10th minute of head-up tilt test with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute systolic orthostatic BP value (mmHg) after 10th minute of head-up tilt test with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute diastolic orthostatic BP value (mmHg) after 10th minute of head-up tilt test with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on OH symptom severity after 3rd minute of head-up tilt test with respect to baseline.
OH symptom severity measured by the "Orthostatic Hypotension Questionnaire (OHQ)" subcale "Orthostatic Hypotension Symptom Assessment" item-#1 [Range: 0 (minimum, i.e. "no symptoms") to 10 (maximum, i.e. "worst possible symptoms")]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on OH symptom severity after 10th minute of head-up tilt test with respect to baseline.
OH symptom severity measured by the "Orthostatic Hypotension Questionnaire (OHQ)" subcale "Orthostatic Hypotension Symptom Assessment" item-#1 [Range: 0 (minimum, i.e. "no symptoms") to 10 (maximum, i.e. "worst possible symptoms")]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on mean BP change (mmHg) after 3rd minute of active standing test with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on systolic BP change (mmHg) after 3rd minute of active standing test with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on diastolic BP change (mmHg) after 3rd minute of active standing test with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute mean orthostatic BP value (mmHg) after 3rd minute of active standing test with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute systolic orthostatic BP value (mmHg) after 3rd minute of active standing test with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute diastolic orthostatic BP value (mmHg) after 3rd minute of active standing test with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on OH symptom severity after 3rd minute of active standing test with respect to baseline.
OH symptom severity measured by the "Orthostatic Hypotension Questionnaire (OHQ)" subcale "Orthostatic Hypotension Symptom Assessment" item-#1 [Range: 0 (minimum, i.e. "no symptoms") to 10 (maximum, i.e. "worst possible symptoms")]
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine mean BP value (mmHg) at 10th minute before head-up tilt test with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine systolic BP value (mmHg) at 10th minute before head-up tilt test with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine diastolic BP value (mmHg) at 10th minute before head-up tilt test with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine mean BP value (mmHg) at 5th minute before active standing test with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine systolic BP value (mmHg) at 5th minute before active standing test with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine diastolic BP value (mmHg) at 5th minute before active standing test with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on in-lab sensor-based mean gait velocity with respect to baseline.
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on in-lab sensor-based mean stride length with respect to baseline.
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on lowest systolic BP values (mmHg) after 3rd minute of home active standing test in the early morning.
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on lowest systolic BP values (mmHg) after 3rd minute of home active standing test 60 minutes after lunch.
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on highest supine systolic BP values (mmHg) at 5th minute before home active standing test in the evening.
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on OH symptom severity.
OH symptom severity measured by the "Orthostatic Hypotension Questionnaire (OHQ)" [Range: 0 (minimum, i.e. "no symptoms") to 100 (maximum, i.e. "worst possible symptoms")], including subcales "Orthostatic Hypotension Symptom Assessment" [Range: 0 (minimum, i.e. "no symptoms") to 60 (maximum, i.e. "worst possible symptoms")] and "Orthostatic Hypotension Daily Activitiy Scale" [Range: 0 (minimum, i.e. "no interference") to 40 (maximum, i.e. "total interference")], as well as single-item scores [Range: 0 (minimum, i.e. "no symptoms/interference") to 10 (maximum, i.e. "worst possible symptoms/total interference")]
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on overall mobility.
Overall mobility measured by the International Physical Activity Questionnaire (IPAQ), indicated in total physical activity metabolic equivalent minutes per week (i.e. total MET-minutes/week) [Range: 0 (minimum, i.e. "no physical activity"), no maximum (i.e. the higher the better the overall mobility)]
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on PAM-derived number of walking bouts.
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on PAM-derived duration of walking bouts.
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on PAM-derived mean gait velocity.
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on PAM-derived mean stride length.
Number of participants with treatment-related adverse events.
Adverse event rates will be coded by body system and MedDRA classification terms. Adverse events will be tabulated by treatment group and will include the number of participants for whom the event occurred, the rate of occurrence, the severity and relationship to the investigational medical device.

Full Information

First Posted
May 26, 2021
Last Updated
August 11, 2023
Sponsor
Universitätsklinik für Neurologie, Innsbruck
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1. Study Identification

Unique Protocol Identification Number
NCT04920552
Brief Title
Abdominal Binders to Treat Orthostatic Hypotension in Parkinsonian Syndromes
Acronym
ABOH-PS
Official Title
Abdominal Binders to Treat Orthostatic Hypotension in Parkinsonian Syndromes: a Randomized, Placebo-controlled, Double-blind, Crossover Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsklinik für Neurologie, Innsbruck

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
Detailed Description
This is a monocentric, randomized, placebo-controlled, double-blind, crossover phase II clinical trial with an open-label treatment extension phase. The investigators plan to recruit n = 30 individuals with MSA-P or PD with known or suspected OH. At the Screening Visit, after patient information and written informed consent, the participants will first undergo a comprehensive neurological and cardiological evaluation, as well cardiovascular autonomic function testing to confirm the diagnosis of symptomatic, neurogenic OH. Afterwards, the participants will be asked to wear physical activity monitoring (PAM) sensors for five consecutive days and to measure the blood pressure (BP) regularly following a home BP diary (i.e. Home Phase I). On treatment day-1 (i.e. Visit 1), the participants will undergo an instrumented in-lab gait analysis, followed by a head-up tilt and active standing test. Afterwards, they will wear the first type of binder for two hours (either the investigational elastic abdominal binder or the placebo-comparator binder, depending on the randomization assignment). At the end of the two hours, the participants will repeat the in-lab gait analysis and the head-up tilt-/active standing test. After one-day wash-out, the same procedure of treatment day-1 (i.e. Visit 1) will be repeated with the outstanding type of binder (i.e. treatment day-2, Visit 2). At the end of this, all participants will be invited to wear the investigational elastic abdominal binder and the PAM sensors for five more days and to repeat the home BP measurements (i.e. Home Phase II). A final follow-up visit is scheduled to return the PAM sensors, the BP monitor and to detect eventual adverse and serious adverse events occurred during Home Phase II.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Multiple System Atrophy, Parkinson Variant, Orthostatic; Hypotension, Neurogenic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
monocentric, randomized, placebo-controlled, double-blind, crossover phase II trial with an open-label treatment extension phase
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo binder first
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will wear the placebo comparator ("Clima Care" body warmer, Bort Medical GmbH) for 2 hours on treatment day-1 (i.e. Visit 1), followed by the active comparator ("ABDO-SYNCRO 3-BAHNIG" elastic abdominal binder, SYNCRO-MED GmbH) for 2 hours on treatment day-2 (i.e. Visit 2).
Arm Title
Elastic abdominal binder first
Arm Type
Active Comparator
Arm Description
Participants in this arm will wear the active comparator ("ABDO-SYNCRO 3-BAHNIG" elastic abdominal binder, SYNCRO-MED GmbH) for 2 hours on treatment day-1 (i.e. Visit 1), followed by the placebo comparator ("Clima Care" body warmer, Bort Medical GmbH) for 2 hours on treatment day-2 (i.e. Visit 2).
Intervention Type
Device
Intervention Name(s)
Elastic abdominal binder
Other Intervention Name(s)
"ABDO-SYNCRO 3-BAHNIG" elastic abdominal binder, SYNCRO-MED GmbH
Intervention Description
The "ABDO-SYNCRO 3-BAHNIG" is an elastic abdominal binder with a 3-stripes Velcro fastening, capable of developing a 20 ± 2 mmHg pressure on the abdominal wall. This device will be tested as potentially beneficial with respect to the mentioned primary and secondary outcomes. The investigators anticipate to use this elastic abdominal binder, since participants of a previous trial reported this device to be comfortable enough and to have used it regularly during the open-label follow-up phase. Size will be chosen depending on the abdominal circumference of the participant, according to the size tables provided from the manufacturer (SYNCRO-MED GmbH).
Intervention Type
Device
Intervention Name(s)
Placebo binder
Other Intervention Name(s)
"Clima Care" body warmer, Bort Medical GmbH
Intervention Description
"Clima Care" is a simple body warmer, developing maximal 3±2 mmHg pressure on the abdominal wall. This device will be used as placebo comparator of the present clinical trial. Size will be chosen depending on the abdominal circumference of the participant, according to the size tables provided from the manufacturer.
Primary Outcome Measure Information:
Title
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.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on systolic BP change (mmHg) after 3rd minute of head-up tilt test with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on diastolic BP change (mmHg) after 3rd minute of head-up tilt test with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on mean BP change (mmHg) after 10th minute of head-up tilt test with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on systolic BP change (mmHg) after 10th minute of head-up tilt test with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on diastolic BP change (mmHg) after 10th minute of head-up tilt test with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute mean orthostatic BP value (mmHg) after 3rd minute of head-up tilt test with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute systolic orthostatic BP value (mmHg) after 3rd minute of head-up tilt test with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute diastolic orthostatic BP value (mmHg) after 3rd minute of head-up tilt test with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute mean orthostatic BP value (mmHg) after 10th minute of head-up tilt test with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute systolic orthostatic BP value (mmHg) after 10th minute of head-up tilt test with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute diastolic orthostatic BP value (mmHg) after 10th minute of head-up tilt test with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on OH symptom severity after 3rd minute of head-up tilt test with respect to baseline.
Description
OH symptom severity measured by the "Orthostatic Hypotension Questionnaire (OHQ)" subcale "Orthostatic Hypotension Symptom Assessment" item-#1 [Range: 0 (minimum, i.e. "no symptoms") to 10 (maximum, i.e. "worst possible symptoms")]
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on OH symptom severity after 10th minute of head-up tilt test with respect to baseline.
Description
OH symptom severity measured by the "Orthostatic Hypotension Questionnaire (OHQ)" subcale "Orthostatic Hypotension Symptom Assessment" item-#1 [Range: 0 (minimum, i.e. "no symptoms") to 10 (maximum, i.e. "worst possible symptoms")]
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on mean BP change (mmHg) after 3rd minute of active standing test with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on systolic BP change (mmHg) after 3rd minute of active standing test with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on diastolic BP change (mmHg) after 3rd minute of active standing test with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute mean orthostatic BP value (mmHg) after 3rd minute of active standing test with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute systolic orthostatic BP value (mmHg) after 3rd minute of active standing test with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on absolute diastolic orthostatic BP value (mmHg) after 3rd minute of active standing test with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on OH symptom severity after 3rd minute of active standing test with respect to baseline.
Description
OH symptom severity measured by the "Orthostatic Hypotension Questionnaire (OHQ)" subcale "Orthostatic Hypotension Symptom Assessment" item-#1 [Range: 0 (minimum, i.e. "no symptoms") to 10 (maximum, i.e. "worst possible symptoms")]
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine mean BP value (mmHg) at 10th minute before head-up tilt test with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine systolic BP value (mmHg) at 10th minute before head-up tilt test with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine diastolic BP value (mmHg) at 10th minute before head-up tilt test with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine mean BP value (mmHg) at 5th minute before active standing test with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine systolic BP value (mmHg) at 5th minute before active standing test with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on supine diastolic BP value (mmHg) at 5th minute before active standing test with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on in-lab sensor-based mean gait velocity with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus a placebo binder for two hours on in-lab sensor-based mean stride length with respect to baseline.
Time Frame
3 days
Title
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on lowest systolic BP values (mmHg) after 3rd minute of home active standing test in the early morning.
Time Frame
10 days
Title
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on lowest systolic BP values (mmHg) after 3rd minute of home active standing test 60 minutes after lunch.
Time Frame
10 days
Title
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on highest supine systolic BP values (mmHg) at 5th minute before home active standing test in the evening.
Time Frame
10 days
Title
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on OH symptom severity.
Description
OH symptom severity measured by the "Orthostatic Hypotension Questionnaire (OHQ)" [Range: 0 (minimum, i.e. "no symptoms") to 100 (maximum, i.e. "worst possible symptoms")], including subcales "Orthostatic Hypotension Symptom Assessment" [Range: 0 (minimum, i.e. "no symptoms") to 60 (maximum, i.e. "worst possible symptoms")] and "Orthostatic Hypotension Daily Activitiy Scale" [Range: 0 (minimum, i.e. "no interference") to 40 (maximum, i.e. "total interference")], as well as single-item scores [Range: 0 (minimum, i.e. "no symptoms/interference") to 10 (maximum, i.e. "worst possible symptoms/total interference")]
Time Frame
10 days
Title
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on overall mobility.
Description
Overall mobility measured by the International Physical Activity Questionnaire (IPAQ), indicated in total physical activity metabolic equivalent minutes per week (i.e. total MET-minutes/week) [Range: 0 (minimum, i.e. "no physical activity"), no maximum (i.e. the higher the better the overall mobility)]
Time Frame
10 days
Title
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on PAM-derived number of walking bouts.
Time Frame
10 days
Title
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on PAM-derived duration of walking bouts.
Time Frame
10 days
Title
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on PAM-derived mean gait velocity.
Time Frame
10 days
Title
Effect of wearing an elastic abdominal binder versus no binder for five consecutive days on PAM-derived mean stride length.
Time Frame
10 days
Title
Number of participants with treatment-related adverse events.
Description
Adverse event rates will be coded by body system and MedDRA classification terms. Adverse events will be tabulated by treatment group and will include the number of participants for whom the event occurred, the rate of occurrence, the severity and relationship to the investigational medical device.
Time Frame
8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 months) requiring anaesthesia; known or suspected pregnancy; breast-feeding female participants.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gregor K. Wenning, Prof. DDr. MSc
Phone
004351250481811
Email
gregor.wenning@i-med.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandra Fanciulli, DDr.
Phone
004351250483238
Email
alessandra.fanciulli@i-med.ac.at
Facility Information:
Facility Name
Medical University Innsbruck
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregor K. Wenning, Prof. DDr. MSc.
Phone
004351250481811
Email
gregor.wenning@i-med.ac.at
First Name & Middle Initial & Last Name & Degree
Alessandra Fanciulli, DDr.
Phone
004351250483238
Email
alessandra.fanciulli@i-med.ac.at

12. IPD Sharing Statement

Citations:
PubMed Identifier
30363559
Citation
Fanciulli A, Goebel G, Metzler B, Sprenger F, Poewe W, Wenning GK, Seppi K. Elastic Abdominal Binders Attenuate Orthostatic Hypotension in Parkinson's Disease. Mov Disord Clin Pract. 2015 Nov 27;3(2):156-160. doi: 10.1002/mdc3.12270. eCollection 2016 Mar-Apr.
Results Reference
background
PubMed Identifier
25587949
Citation
Fanciulli A, Wenning GK. Multiple-system atrophy. N Engl J Med. 2015 Jan 15;372(3):249-63. doi: 10.1056/NEJMra1311488. No abstract available.
Results Reference
background
PubMed Identifier
32716319
Citation
Fanciulli A, Leys F, Falup-Pecurariu C, Thijs R, Wenning GK. Management of Orthostatic Hypotension in Parkinson's Disease. J Parkinsons Dis. 2020;10(s1):S57-S64. doi: 10.3233/JPD-202036.
Results Reference
background

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Abdominal Binders to Treat Orthostatic Hypotension in Parkinsonian Syndromes

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