NCT02874261

Brief Summary

Whole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a diverse and growing list of disorders including cardiovascular disease. During WBPA, patients lie in the supine position on a bed that is capable of translating back and forth parallel to the ground, along the head-to-foot axis of the patient. Thus, this treatment is best described as a form of "passive exercise." The frequency of the translation (up to 180 cycles/minute; cpm) as well as the distance traveled (2-24mm) by the bed can be adjusted by the patient or health care professional. The science behind the therapeutic effects of WBPA still remains largely unknown. The investigators are observing how WBPA may impact on sleep and activity in individuals with Parkinson's disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

August 17, 2016

Last Update Submit

September 28, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sleep patterns using an activity monitor on the wrist

    The investigators will record sleep patterns a week before WBPA through out the 4 weeks of WBPA and then one week post WBPA using an activity monitor on the wrist

    6 weeks

Secondary Outcomes (2)

  • Pittsburgh Sleep Quality Index

    6 weeks

  • Physical Activity (steps per day using an activity monitor on the wrist)

    6 weeks

Study Arms (1)

Whole Body Periodic Acceleration

EXPERIMENTAL

Whole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a diverse and growing list of disorders including cardiovascular disease 6. During WBPA, patients lie in the supine position on a bed that is capable of translating back and forth parallel to the ground, along the head-to-foot axis of the patient. Thus, this treatment is best described as a form of "passive exercise." The frequency of the translation is 120 cycles/minute; cpm) as well as a distance traveled 16 mm.

Device: Whole Body Periodic Acceleration

Interventions

oscillating bed that the subject will lie on 3 days a week for 45 minutes at 140 cycles per minute.

Also known as: WBPA
Whole Body Periodic Acceleration

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy individuals between the ages of 50-80
  • Individuals with Parkinsons disease between the ages of 50-80
  • Individuals with a smart phone

You may not qualify if:

  • Any condition that prevents you from lying flat on your back, any other neurological condition than Parkinson's disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYIT

Old Westbury, New York, 11568568, United States

Location

MeSH Terms

Conditions

Sleep Wake DisordersMotor Activity

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavior

Study Officials

  • Veronica Southard, DPT

    NYIT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 22, 2016

Study Start

May 1, 2015

Primary Completion

May 1, 2017

Study Completion

June 1, 2017

Last Updated

October 2, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations