Back to resultsVibration Training for Preventing Falls in Healthy Population and Multiple Sclerosis
Primary Purpose
Falls Prevention
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Controlled whole-body vibration training
Sponsored by
About this trial
This is an interventional prevention trial for Falls Prevention
Eligibility Criteria
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
Sites / Locations
- Georgia State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vibration training group
Placebo training group
Arm Description
The vibration group will receive 8-week controlled whole-body vibration training as the intervention on the Galileo Med L device
The placebo group will receive 8-week placebo training on the Galileo Med L device
Outcomes
Primary Outcome Measures
Real life falls
Real life falls are monitored for 12 months.
Secondary Outcome Measures
Berg Balance Scale test
This test is used to assess the body balance skill in healthy elderly.
Slip-related falls on treadmill
Participants will be exposed to unexpected slips during walking on a treadmill.
Functional mobility
Functional mobility is measured by using the Timed-Up-and-Go test.
Sensation
Sensation is measured by nylon monofilaments kit.
Muscle strength
Lower-limb joints' muscle strengths are evaluated by an isokinetic dynamometer.
Range of motion
The range of motion of the lower limb joints are assessed by a goniometer.
Bone density
The bone density of the heel bone is assessed by a bone ultrasonometer.
Multiple Sclerosis Functional Composite score
The Multiple Sclerosis Functional Composite score, which indicates the disability level in people with multiple sclerosis, is measured
Equiscale balance test
This balance test is applied to individuals with multiple sclerosis to evaluate their body balance skill.
Symbol Digit Modalities test
This test measures participants' attention and information processing speed and efficiency.
Selective Reminding test
This instrument assesses participants' verbal learning and memory capacity.
Behavior Rating Inventory of Executive Function
This test is used to gauge one's everyday behaviors associated with specific domains of the executive functions.
Full Information
NCT ID
NCT02694666
First Posted
February 10, 2016
Last Updated
September 25, 2022
Sponsor
Georgia State University
1. Study Identification
Unique Protocol Identification Number
NCT02694666
Brief Title
Vibration Training for Preventing Falls in Healthy Population and Multiple Sclerosis
Official Title
Effects of Controlled Whole-body Vibration Training on Preventing Falls Among Healthy Population and Ambulatory People With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgia State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Falls Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
147 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vibration training group
Arm Type
Experimental
Arm Description
The vibration group will receive 8-week controlled whole-body vibration training as the intervention on the Galileo Med L device
Arm Title
Placebo training group
Arm Type
Placebo Comparator
Arm Description
The placebo group will receive 8-week placebo training on the Galileo Med L device
Intervention Type
Other
Intervention Name(s)
Controlled whole-body vibration training
Other Intervention Name(s)
Vibration therapy; vibration training
Intervention Description
The intervention is an 8-week program
Primary Outcome Measure Information:
Title
Real life falls
Description
Real life falls are monitored for 12 months.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Berg Balance Scale test
Description
This test is used to assess the body balance skill in healthy elderly.
Time Frame
Up to 12 months
Title
Slip-related falls on treadmill
Description
Participants will be exposed to unexpected slips during walking on a treadmill.
Time Frame
Up to 12 months
Title
Functional mobility
Description
Functional mobility is measured by using the Timed-Up-and-Go test.
Time Frame
Up to 12 months
Title
Sensation
Description
Sensation is measured by nylon monofilaments kit.
Time Frame
Up to 12 months
Title
Muscle strength
Description
Lower-limb joints' muscle strengths are evaluated by an isokinetic dynamometer.
Time Frame
Up to 12 months
Title
Range of motion
Description
The range of motion of the lower limb joints are assessed by a goniometer.
Time Frame
Up to 12 months
Title
Bone density
Description
The bone density of the heel bone is assessed by a bone ultrasonometer.
Time Frame
Up to 12 months
Title
Multiple Sclerosis Functional Composite score
Description
The Multiple Sclerosis Functional Composite score, which indicates the disability level in people with multiple sclerosis, is measured
Time Frame
Up to 12 months
Title
Equiscale balance test
Description
This balance test is applied to individuals with multiple sclerosis to evaluate their body balance skill.
Time Frame
Up to 12 months
Title
Symbol Digit Modalities test
Description
This test measures participants' attention and information processing speed and efficiency.
Time Frame
Up to 12 months
Title
Selective Reminding test
Description
This instrument assesses participants' verbal learning and memory capacity.
Time Frame
Up to 12 months
Title
Behavior Rating Inventory of Executive Function
Description
This test is used to gauge one's everyday behaviors associated with specific domains of the executive functions.
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Yang, PhD
Organizational Affiliation
Georgia State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia State University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vibration Training for Preventing Falls in Healthy Population and Multiple Sclerosis
We'll reach out to this number within 24 hrs