Vibration Training for Preventing Falls in Healthy Population and Multiple Sclerosis

Not Applicable

Terminated

• Conditions: Falls Prevention
• Interventions: Other: Controlled whole-body vibration training

• Registration Number: NCT02694666
• Lead Sponsor: Georgia State University

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 Timeline

• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-23
• Study First Posted: 2016-02-29
• Study Start: 2016-04
• Primary Completion: 2023-04-10
• Study Completion: 2023-04-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo training group	Controlled whole-body vibration training	The placebo group will receive 8-week placebo training on the Galileo Med L device
Vibration training group	Controlled whole-body vibration training	The vibration group will receive 8-week controlled whole-body vibration training as the intervention on the Galileo Med L device

Primary Outcome Measures

Name	Time	Method
Real life falls	Up to 12 months	Real life falls are monitored for 12 months.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Georgia State University; 🇺🇸 Atlanta, Georgia, United States