Posture Detection for Automated Abdominal Binder

NCT02280369 | Completed DMC

• 1 other identifier: 140749
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The automated inflatable abdominal binder is an investigational device for the treatment of orthostatic hypotension (low blood pressure on standing) in autonomic failure patients. The purpose of this study is to evaluate the performance of the binder in detecting body posture during different types of human motion patterns and activities of daily living, and to develop new (and better) ways to detect upright posture. In particular, the investigators want to determine if activities of daily living, normally encountered by patients (lying down, sitting, standing, walking, and climbing up and down steps), interfere with the detection of upright posture used to trigger the device. Studies will be conducted in healthy subjects because the main purpose of this study is to evaluate posture detection rather than treating orthostatic hypotension.

Conditions

Hypotension, Orthostatic

Keywords

posture detection; healthy subjects

Outcome Measures

Primary Outcomes (1)

• Percentage of times the thigh and waist accelerometer sensors correctly detect upright posture.

  during 5-10 minutes performing each activity (lying down, sitting, standing, climbing steps, walking)

Study Arms (1)

automated abdominal binder

automated abdominal binder with waist and thigh accelerometers, and ActivPAL

Device: Automated abdominal binder

Interventions

Automated abdominal binder DEVICE

Inflatable abdominal binder

automated abdominal binder

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

You may qualify if:

• Body mass index \<30 Kg/m2.
• Able and willing to provide informed consent.

You may not qualify if:

• Pregnancy.
• Any major medical problems or systemic illnesses known to produce orthostatic intolerance.
• Other factors which in the investigator's opinion would prevent the subject from completing the protocol including clinically significant abnormalities in clinical, mental or laboratory testing during the screening

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Italo Biaggioni, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Pharmacology

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: October 31, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

US (1)