Study Stopped
Lack of funding.
Vibration Training for Preventing Falls in Healthy Population and Multiple Sclerosis
Effects of Controlled Whole-body Vibration Training on Preventing Falls Among Healthy Population and Ambulatory People With Multiple Sclerosis
1 other identifier
interventional
58
1 country
1
Brief Summary
This study is to investigate the effects of controlled whole-body vibration training on reducing the likelihood of falls among healthy population and people with multiple sclerosis. (NOTE: research not covered by sponsored funding)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2016
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
February 10, 2016
CompletedFirst Posted
Study publicly available on registry
February 29, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2023
CompletedNovember 18, 2023
November 1, 2023
7 years
February 10, 2016
November 16, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Real life falls
Real life falls are monitored for 12 months.
Up to 12 months
Secondary Outcomes (12)
Berg Balance Scale test
Up to 12 months
Slip-related falls on treadmill
Up to 12 months
Functional mobility
Up to 12 months
Sensation
Up to 12 months
Muscle strength
Up to 12 months
- +7 more secondary outcomes
Study Arms (2)
Vibration training group
EXPERIMENTALThe vibration group will receive 8-week controlled whole-body vibration training as the intervention on the Galileo Med L device
Placebo training group
PLACEBO COMPARATORThe placebo group will receive 8-week placebo training on the Galileo Med L device
Interventions
The intervention is an 8-week program
Eligibility Criteria
You may qualify if:
- For healthy population:
- Aged between 18 and 75
- No known history of musculoskeletal, neurological, cardiovascular, or pulmonary impairment
- For people with multiple sclerosis
- Self-reported multiple sclerosis and confirmed by the physician
- No significant relapse within the past 8 weeks
- To be able to walk independently a length of 25 feet
- Score on Patient Determined Disease Step \< 7
You may not qualify if:
- Subjects use any sedative of any type.
- The heel bone density is less than -2.0
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Georgia State University
Atlanta, Georgia, 30303, United States
Related Publications (1)
Yang F, Su X, Sanchez MC, Hackney ME, Butler AJ. Vibration training reducing falls in community-living older adults: a pilot randomized controlled trial. Aging Clin Exp Res. 2023 Apr;35(4):803-814. doi: 10.1007/s40520-023-02362-6. Epub 2023 Feb 13.
PMID: 36781617DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Feng Yang, PhD
Georgia State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 10, 2016
First Posted
February 29, 2016
Study Start
April 1, 2016
Primary Completion
April 10, 2023
Study Completion
April 10, 2023
Last Updated
November 18, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share