NCT02694666

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

57
Monitor

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

7 years

First QC Date

February 10, 2016

Last Update Submit

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

EXPERIMENTAL

The vibration group will receive 8-week controlled whole-body vibration training as the intervention on the Galileo Med L device

Other: Controlled whole-body vibration training

Placebo training group

PLACEBO COMPARATOR

The placebo group will receive 8-week placebo training on the Galileo Med L device

Other: Controlled whole-body vibration training

Interventions

The intervention is an 8-week program

Also known as: Vibration therapy; vibration training
Placebo training groupVibration training group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

Study Officials

  • Feng Yang, PhD

    Georgia State University

    PRINCIPAL INVESTIGATOR

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

Locations