Falls PreventionNCT02694666
Vibration Training for Preventing Falls in Healthy Population and Multiple Sclerosis
A study of Falls Prevention, run by Georgia State University at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Falls Prevention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 10 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects use any sedative of any type.
- The heel bone density is less than -2.0
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the detailed description
For each population, the participants will be randomized into two groups.
- Conditions
- Falls Prevention
- Being tested
- Controlled whole-body vibration training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled whole-body vibration trainingOther
Also called Vibration therapy; vibration training
The intervention is an 8-week program
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Controlled whole-body vibration training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real life falls
Real life falls are monitored for 12 months.
Measured: Up to 12 months
Secondary outcomes (12)
Berg Balance Scale test
This test is used to assess the body balance skill in healthy elderly.
Measured: Up to 12 months
Slip-related falls on treadmill
Participants will be exposed to unexpected slips during walking on a treadmill.
Measured: Up to 12 months
Functional mobility
Functional mobility is measured by using the Timed-Up-and-Go test.
Measured: Up to 12 months
Sensation
Sensation is measured by nylon monofilaments kit.
Measured: Up to 12 months
Muscle strength
Lower-limb joints' muscle strengths are evaluated by an isokinetic dynamometer.
Measured: Up to 12 months
Range of motion
The range of motion of the lower limb joints are assessed by a goniometer.
Measured: Up to 12 months
Bone density
The bone density of the heel bone is assessed by a bone ultrasonometer.
Measured: 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
Measured: Up to 12 months
Equiscale balance test
This balance test is applied to individuals with multiple sclerosis to evaluate their body balance skill.
Measured: Up to 12 months
Symbol Digit Modalities test
This test measures participants' attention and information processing speed and efficiency.
Measured: Up to 12 months
Selective Reminding test
This instrument assesses participants' verbal learning and memory capacity.
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startApr 2016
- Primary completion10 Apr 2023
- Study completion10 Apr 2023
Why it stopped: Lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Falls PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Yang, PhD, Georgia State University
- Investigators
- Feng Yang, PhD, Principal investigator, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694666
- Sponsor's protocol ID
- 514810
- Status last verified
- Nov 2023
- First submitted
- 10 Feb 2016
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36781617
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Controlled Whole-body Vibration Training on Preventing Falls Among Healthy Population and Ambulatory People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02694666
- Acronym / sponsor ID
- 514810
- Conditions
- Falls Prevention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding.
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibration training group | Experimental | Other: Controlled whole-body vibration trainingThe vibration group will receive 8-week controlled whole-body vibration training as the intervention on the Galileo Med L device |
| Placebo training group | Placebo comparator | Other: Controlled whole-body vibration trainingThe placebo group will receive 8-week placebo training on the Galileo Med L device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Subjects use any sedative of any type.
- The heel bone density is less than -2.0
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled whole-body vibration trainingAlso: Vibration therapy; vibration trainingThe intervention is an 8-week program | Other | Placebo training group, Vibration training group |
Primary outcome
Real life falls
Time frame: Up to 12 months
Real life falls are monitored for 12 months.
12 secondary outcomes
Berg Balance Scale test
Time frame: Up to 12 months
Slip-related falls on treadmill
Time frame: Up to 12 months
Functional mobility
Time frame: Up to 12 months
Sensation
Time frame: Up to 12 months
Muscle strength
Time frame: Up to 12 months
Range of motion
Time frame: Up to 12 months
Bone density
Time frame: Up to 12 months
Multiple Sclerosis Functional Composite score
Time frame: Up to 12 months
Equiscale balance test
Time frame: Up to 12 months
Symbol Digit Modalities test
Time frame: Up to 12 months
Selective Reminding test
Time frame: Up to 12 months
Behavior Rating Inventory of Executive Function
Time frame: Up to 12 months
Results and safety
The study was stopped early (reason given: Lack of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 36781617Yang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feng Yang, PhD principal investigator
Georgia State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Falls Prevention, run by Georgia State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real life falls (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02694666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.