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

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)

Study Overview

• Status: Terminated
• Conditions: Falls Prevention
• Intervention / Treatment: Other: Controlled whole-body vibration training

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Georgia State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vibration training group; 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; The intervention is an 8-week program; Other Names: Vibration therapy; vibration training
Placebo Comparator: Placebo training group; The placebo group will receive 8-week placebo training on the Galileo Med L device	Other: Controlled whole-body vibration training; The intervention is an 8-week program; Other Names: Vibration therapy; vibration training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Real life falls	Real life falls are monitored for 12 months.	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale test	This test is used to assess the body balance skill in healthy elderly.	Up to 12 months
Slip-related falls on treadmill	Participants will be exposed to unexpected slips during walking on a treadmill.	Up to 12 months
Functional mobility	Functional mobility is measured by using the Timed-Up-and-Go test.	Up to 12 months
Sensation	Sensation is measured by nylon monofilaments kit.	Up to 12 months
Muscle strength	Lower-limb joints' muscle strengths are evaluated by an isokinetic dynamometer.	Up to 12 months
Range of motion	The range of motion of the lower limb joints are assessed by a goniometer.	Up to 12 months
Bone density	The bone density of the heel bone is assessed by a bone ultrasonometer.	Up to 12 months
Multiple Sclerosis Functional Composite score	The Multiple Sclerosis Functional Composite score, which indicates the disability level in people with multiple sclerosis, is measured	Up to 12 months
Equiscale balance test	This balance test is applied to individuals with multiple sclerosis to evaluate their body balance skill.	Up to 12 months
Symbol Digit Modalities test	This test measures participants' attention and information processing speed and efficiency.	Up to 12 months
Selective Reminding test	This instrument assesses participants' verbal learning and memory capacity.	Up to 12 months
Behavior Rating Inventory of Executive Function	This test is used to gauge one's everyday behaviors associated with specific domains of the executive functions.	Up to 12 months

Collaborators and Investigators

• Sponsor: Georgia State University
• Investigators: Principal Investigator: Feng Yang, PhD, Georgia State University

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): April 10, 2023
• Study Completion (Actual): April 10, 2023

Study Registration Dates

• First Submitted: February 10, 2016
• First Submitted That Met QC Criteria: February 23, 2016
• First Posted (Estimated): February 29, 2016

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• Other Study ID Numbers: 514810

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No