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Clinical Trials/NCT02694666
NCT02694666TerminatedNot Applicable

Effects of Controlled Whole-body Vibration Training on Preventing Falls Among Healthy Population and Ambulatory People With Multiple Sclerosis

Georgia State University1 site in 1 country58 target enrollmentStarted: April 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
58
Locations
1
Primary Endpoint
Real life falls

Study Overview

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)

Detailed Description

For each population, the participants will be randomized into two groups.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Exclusion Criteria

  • •Subjects use any sedative of any type.
  • •The heel bone density is less than -2.0

Arms & Interventions

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

Intervention: Controlled whole-body vibration training (Other)

Placebo training group

Placebo Comparator

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

Intervention: Controlled whole-body vibration training (Other)

Outcomes

Primary Outcomes

Real life falls

Time Frame: Up to 12 months

Real life falls are monitored for 12 months.

Secondary Outcomes

  • Range of motion(Up to 12 months)
  • Slip-related falls on treadmill(Up to 12 months)
  • Functional mobility(Up to 12 months)
  • Behavior Rating Inventory of Executive Function(Up to 12 months)
  • Sensation(Up to 12 months)
  • Multiple Sclerosis Functional Composite score(Up to 12 months)
  • Berg Balance Scale test(Up to 12 months)
  • Muscle strength(Up to 12 months)
  • Bone density(Up to 12 months)
  • Selective Reminding test(Up to 12 months)
  • Equiscale balance test(Up to 12 months)
  • Symbol Digit Modalities test(Up to 12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Feng Yang, PhD

Assistant Professor

Georgia State University

Study Sites (1)

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