AgingNCT01896466
Enhanced Gait and Balance Training
A study testing Cranial Nerve Non-Invasive Neuromodulation in people with Aging and Accidental Falls, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is twofold: 1. Establish baseline measures of gait performance in healthy young and older adults, and older adults with a history of falls. 2. Investigate the effects of gait and balance training with and without cranial nerve noninvasive neuromodulation (CN-NINM) on postural balance and gait… Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Accidental Falls
- What is being tested?
- Cranial Nerve Non-Invasive Neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Dec 2015
- 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 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community-dwelling
- Able to understand and give informed consent
- Able to stand and walk independently without an assistive device
- No contraindication to exercise
- 1. Healthy young adults
- Between ages of 18 and 39
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- Scores above 19 on Dynamic Gait Index 2. Healthy older adults without a history of falls
- Age 65+
- Scores above 19 on Dynamic Gait Index 3. Older adults with a history of falls
- Age 65+
- Self-reported history of 1-3 falls in previous year
- Scores of 19 and below on the Dynamic Gait Index
Who cannot join
- History of musculoskeletal disorders (lower-limb joint replacement, radiographic evidence of severe osteoarthritis, broken leg bone or ligament/tendon injury in prior 6 months)
- Use of tobacco products
- Any oral abrasions, cuts, cold sores, piercings, tissue inflammation, or have had oral surgery within the previous 3 months
- Have a pacemaker or are identified as at-risk for cardiovascular events
- Have a biomechanical prosthetic
- If female, self-report of being pregnant
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- Neurological condition
- Prisoners
- Individuals clearly lacking the capacity to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53706
About this study
Official title: Influence of Neuromodulation on Gait and Balance
The purpose of this study is twofold:
- Establish baseline measures of gait performance in healthy young and older adults, and older adults with a history of falls.
- Investigate the effects of gait and balance training with and without cranial nerve noninvasive neuromodulation (CN-NINM) on postural balance and gait performance in older adults.
For the second purpose, the study will incorporate a placebo-controlled design to evaluate the effects of CN-NINM augmented exercise compared to physical exercises alone. Both groups will perform gait and postural balance training (outlined in more detail below) but will differ in the stimulation level of the PoNS device. The investigators will use the results of this study as a first step toward evaluating the benefits of CN-NINM in a falls prevention program.
- Conditions
- Aging, Accidental Falls
- Being tested
- Cranial Nerve Non-Invasive Neuromodulation, Sham Cranial Nerve Non-Invasive Neuromodulation
- Keywords
- Fall Risk, Gait, Dynamic Balance, Static Balance, Neuromodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial Nerve Non-Invasive NeuromodulationDevice
Also called PoNS (Portable Neuromodulation Stimulator)
Portable device delivers electrical stimulation to cranial nerves V and VII via an electrode array placed on the anterior surface of the tongue. Stimulation is combined with rehabilitation exercises targeting walking and balance.
Sham Cranial Nerve Non-Invasive NeuromodulationBehavioural
Subjects participate in gait and balance rehabilitation exercises while using a device set to sub-threshold levels.
| Study group | Role | What they receive |
|---|---|---|
| Young Adults - Intervention | Active comparator | Healthy subjects between the ages of 18-39 will participate in Cranial Nerve Non-Invasive Neuromodulation gait and balance training. Receives: Device: Cranial Nerve Non-Invasive Neuromodulation |
| Healthy Older Adults - Control | Active comparator | Healthy subjects between age 65+ will participate in Sham Cranial Nerve Non-Invasive Neuromodulation gait and balance training. Receives: Behavioral: Sham Cranial Nerve Non-Invasive Neuromodulation |
| Healthy Older Adults - Intervention | Active comparator | Healthy subjects age 65+ will participate in Cranial Nerve Non-Invasive Neuromodulation enhanced gait and balance training. Receives: Device: Cranial Nerve Non-Invasive Neuromodulation |
| Older Fallers - Control | Sham comparator | Subjects who are age 65+ with a history of 1-3 falls in the previous six months will participate in Sham Cranial Nerve Non-Invasive Neuromodulation gait and balance training. Receives: Behavioral: Sham Cranial Nerve Non-Invasive Neuromodulation |
| Older Fallers - Intervention | Experimental | Subjects who are age 65+ with a history of 1-3 falls in the previous six months will participate in Cranial Nerve Non-Invasive Neuromodulation enhanced gait and balance training. Receives: Device: Cranial Nerve Non-Invasive Neuromodulation |
| Young Adult - Control | Active comparator | Healthy subjects between the ages of 18-39 will participate in Sham Cranial Nerve Non-Invasive Neuromodulation gait and balance training. Receives: Behavioral: Sham Cranial Nerve Non-Invasive Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Gait Index
An 8-item inventory of functional gait tasks each scored on a 0-3 point scale. Maximum score is 24 and any score of 19 or lower indicates an increased risk of falling.
Measured: Day 1 and approximately Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Darryl G Thelen, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896466
- Sponsor's protocol ID
- 2013-0394
- Status last verified
- Jul 2019
- First submitted
- 10 Jun 2013
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Neuromodulation on Gait and Balance
- ClinicalTrials.gov ID
- NCT01896466
- Acronym / sponsor ID
- 2013-0394
- Conditions
- Aging, Accidental Falls
- Keywords
- Fall Risk, Gait, Dynamic Balance, Static Balance, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Jul 2013 (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.
The purpose of this study is twofold:
- Establish baseline measures of gait performance in healthy young and older adults, and older adults with a history of falls.
- Investigate the effects of gait and balance training with and without cranial nerve noninvasive neuromodulation (CN-NINM) on postural balance and gait performance in older adults.
For the second purpose, the study will incorporate a placebo-controlled design to evaluate the effects of CN-NINM augmented exercise compared to physical exercises alone. Both groups will perform gait and postural balance training (outlined in more detail below) but will differ in the stimulation level of the PoNS device. The investigators will use the results of this study as a first step toward evaluating the benefits of CN-NINM in a falls prevention program.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Young Adults - Intervention | Active comparator | Device: Cranial Nerve Non-Invasive NeuromodulationHealthy subjects between the ages of 18-39 will participate in Cranial Nerve Non-Invasive Neuromodulation gait and balance training. |
| Healthy Older Adults - Control | Active comparator | Behavioral: Sham Cranial Nerve Non-Invasive NeuromodulationHealthy subjects between age 65+ will participate in Sham Cranial Nerve Non-Invasive Neuromodulation gait and balance training. |
| Healthy Older Adults - Intervention | Active comparator | Device: Cranial Nerve Non-Invasive NeuromodulationHealthy subjects age 65+ will participate in Cranial Nerve Non-Invasive Neuromodulation enhanced gait and balance training. |
| Older Fallers - Control | Sham comparator | Behavioral: Sham Cranial Nerve Non-Invasive NeuromodulationSubjects who are age 65+ with a history of 1-3 falls in the previous six months will participate in Sham Cranial Nerve Non-Invasive Neuromodulation gait and balance training. |
| Older Fallers - Intervention | Experimental | Device: Cranial Nerve Non-Invasive NeuromodulationSubjects who are age 65+ with a history of 1-3 falls in the previous six months will participate in Cranial Nerve Non-Invasive Neuromodulation enhanced gait and balance training. |
| Young Adult - Control | Active comparator | Behavioral: Sham Cranial Nerve Non-Invasive NeuromodulationHealthy subjects between the ages of 18-39 will participate in Sham Cranial Nerve Non-Invasive Neuromodulation gait and balance training. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Community-dwelling
- Able to understand and give informed consent
- Able to stand and walk independently without an assistive device
- No contraindication to exercise
- 1. Healthy young adults
Key exclusion criteria (9 listed)
- History of musculoskeletal disorders (lower-limb joint replacement, radiographic evidence of severe osteoarthritis, broken leg bone or ligament/tendon injury in prior 6 months)
- Use of tobacco products
- Any oral abrasions, cuts, cold sores, piercings, tissue inflammation, or have had oral surgery within the previous 3 months
- Have a pacemaker or are identified as at-risk for cardiovascular events
- Have a biomechanical prosthetic
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 |
|---|---|---|
| Cranial Nerve Non-Invasive NeuromodulationAlso: PoNS (Portable Neuromodulation Stimulator)Portable device delivers electrical stimulation to cranial nerves V and VII via an electrode array placed on the anterior surface of the tongue. Stimulation is combined with rehabilitation exercises targeting walking and balance. | Device | Healthy Older Adults - Intervention, Older Fallers - Intervention, Young Adults - Intervention |
| Sham Cranial Nerve Non-Invasive NeuromodulationSubjects participate in gait and balance rehabilitation exercises while using a device set to sub-threshold levels. | Behavioural | Healthy Older Adults - Control, Older Fallers - Control, Young Adult - Control |
Primary outcome
Dynamic Gait Index
Time frame: Day 1 and approximately Day 12
An 8-item inventory of functional gait tasks each scored on a 0-3 point scale. Maximum score is 24 and any score of 19 or lower indicates an increased risk of falling.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
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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.
Darryl G Thelen, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranial Nerve Non-Invasive Neuromodulation in people with Aging and Accidental Falls, run by University of Wisconsin, Madison 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 12 inclusion and 9 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: finished, as of the sponsor's last update on 31 Jul 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dynamic Gait Index (time frame: Day 1 and approximately Day 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2019.