Effect of Age-related Changes in the Brain on Walking AbilityNCT03737760
"Mind in Motion": Multimodal Imaging of Brain Activity to Investigate Walking and Mobility Decline in Older Adults
An observational study of Effect of Age-related Changes in the Brain on Walking Ability, run by University of Florida at 1 site in United States.
Trial summary
The objective of this study is to determine the central neural control of mobility in older adults by acquiring data with multiple modalities of neuroimaging (EEG, fNIRS, MRI) and associating these data with a comprehensive set of diverse mobility outcomes (clinic-based walking, complex walking and community mobility… Read more about this study
- Who is it for?
- Ages 20 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Age-related Changes in the Brain on Walking Ability
- How many people
- 279 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2019to 31 May 2025
- Phase
- Observational
- 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 20 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Older adults (age 70+) and young adults (age 20-40)
Who may be able to join
- Community dwelling men and women 65+ years old, or 60+ for individuals who belong to underrepresented racial or ethnic groups;
- Short Physical Performance Battery (SPPB) <10 (45% of the sample will have an SPPB < 8) for moderate to low functioning older adults; SPPB>=10 for high functioning older adults
- Able to complete the 400 m walk test within 15 minutes without sitting or the help of another person and without a walker, a cane is allowed
- Willingness to undergo all testing procedures
- English speaking
- Willingness to be enrolled for 1.25 to 3.5 years, depending on enrollment date.
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- Healthy men and women aged 20-40 years old
- Willingness to undergo all testing procedures
- English speaking
Who cannot join
- Significant medical event requiring hospitalization in the past 6 months that has the potential to contaminate data being collected (fracture, hospitalization etc.);
- Severe visual impairment or corrected visual acuity less than 20/40, which would preclude completion of the assessments;
- Not meeting MRI eligibility (e.g. metal implants, pacemaker, etc.)
- Clinically diagnosed vestibular dysfunction;
- Unwilling or unable to do an over-ground version of the uneven terrain task without assistive device;
- Develops chest pain or severe shortness of breath during physical stress;
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- Stroke or other brain injury within the past three years;
- Current presence of motor deficits caused by a stroke or other brain injury;
- Diagnosis of dementia or taking cholinesterase inhibitors (Aricept, Exelon, Razadyne, Namenda, or Namzaric);
- Any major ADL disability (unable to feed, dress, bath, use the toilet, or transfer);
- Report of severe lower extremity pain that significantly limits mobility;
- Diagnosis or treatment for rheumatoid arthritis;
- Lives in a nursing home; persons living in assisted or independent housing will not be excluded;
- Receiving physical therapy for gait, balance, or other lower extremity training;
- Known neuromuscular disorder or overt neurological disease (e.g. Multiple Sclerosis, Rhabdomyolysis, Myasthenia Gravis, Ataxia, Apraxia, post-polio syndrome, mitochondrial myopathy, Parkinson's Disease, ALS etc.)
- Unable to communicate because of severe hearing loss or speech disorder;
- Planned surgical procedure or hospitalization in the next 12 months (e.g., joint replacement, CABG);
- Severe pulmonary disease, requiring the use of supplemental oxygen;
- Terminal illness, as determined by a physician;
- Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, recent history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina;
- Is planning to move out of the area in next year or leave the area for >6 mos during follow-up;
- Other significant conditions that would impact safety and/or compliance to the protocol (e.g. renal failure on hemodialysis, psychiatric disorder-bipolar, schizophrenia, excessive alcohol intake etc.);
- -Actively enrolled in an intervention study
- Use of walker or wheel chair;
- Artificial hair covering the scalp such as a wig or toupee
- Failure to provide informed consent;
- Transaminases >twice upper limit of normal;
- Hemoglobin <10 g/dL;
- Investigator discretion based on safety or compliance concerns
- -Temporary exclusion criteria (participant may be eligible if these issues are resolved in the future):
- Abnormalities in blood chemistry parameters as defined above;
- Severe hypertension, e.g., SBP > 200, DBP > 110 mmHg;
- Uncontrolled diabetes or hyperglycemia (fasting blood glucose > 126 mg/dl or hemoglobin A1C > 6.5%)
- Other temporary events that would influence participation (e.g. episodic health event, sick spouse, bereavement, or recent move);
- Other conditions identified with medical history at enrollment that places the participant at risk for participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multimodal Imaging of Brain Activity to Investigate Walking and Mobility Decline in Older Adults
The objective of this study is to determine the central neural control of mobility in older adults by acquiring data with multiple modalities of neuroimaging (EEG, fNIRS, MRI) and associating these data with a comprehensive set of diverse mobility outcomes (clinic-based walking, complex walking and community mobility measures).
Read the detailed description
This study is a longitudinal, prospective cohort study with a follow-up period of 1.2 - 3.5 years, dependent on when the participant enrolls. Participants will be assessed at baseline, and then every six months for 3.5 years or until the study ends, whichever comes first.
The investigators plan to enroll 200 community-dwelling men and women age 70+ years.
- Keywords
- walking, aging, brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Older Adults | Community-dwelling men and women age 70+ years | |
| Younger Adults | Healthy young adults, age 20-40 years for baseline assessments only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activity during walking
Changes in brain activity during complex walking (uneven terrain), assessed longitudinally for up to 3.5 years
Measured: Baseline up to 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start19 Apr 2019
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Age-related Changes in the Brain on Walking AbilityStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- David Clark, ScD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737760
- Sponsor's protocol ID
- IRB201802227-N
- Other IDs
- 1U01AG061389-01, OCR19439, P30AG059297, IRB201900001, IRB202201585
- Status last verified
- Jul 2025
- First submitted
- 8 Nov 2018
- Last updated
- 17 Jul 2025
- 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 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Imaging of Brain Activity to Investigate Walking and Mobility Decline in Older Adults
- ClinicalTrials.gov ID
- NCT03737760
- Acronym / sponsor ID
- IRB201802227-N
- Keywords
- walking, aging, brain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 9 Nov 2018 (actual)
- 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 objective of this study is to determine the central neural control of mobility in older adults by acquiring data with multiple modalities of neuroimaging (EEG, fNIRS, MRI) and associating these data with a comprehensive set of diverse mobility outcomes (clinic-based walking, complex walking and community mobility measures).
Detailed description
This study is a longitudinal, prospective cohort study with a follow-up period of 1.2 - 3.5 years, dependent on when the participant enrolls. Participants will be assessed at baseline, and then every six months for 3.5 years or until the study ends, whichever comes first.
The investigators plan to enroll 200 community-dwelling men and women age 70+ years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Older Adults | – | –Community-dwelling men and women age 70+ years |
| Younger Adults | – | –Healthy young adults, age 20-40 years for baseline assessments only |
Who may qualify
- Ages
- 20 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Older adults (age 70+) and young adults (age 20-40)
Key inclusion criteria (9 listed)
- Community dwelling men and women 65+ years old, or 60+ for individuals who belong to underrepresented racial or ethnic groups;
- Short Physical Performance Battery (SPPB) <10 (45% of the sample will have an SPPB < 8) for moderate to low functioning older adults; SPPB>=10 for high functioning older adults
- Able to complete the 400 m walk test within 15 minutes without sitting or the help of another person and without a walker, a cane is allowed
- Willingness to undergo all testing procedures
- English speaking
Key exclusion criteria (35 listed)
- Significant medical event requiring hospitalization in the past 6 months that has the potential to contaminate data being collected (fracture, hospitalization etc.);
- Severe visual impairment or corrected visual acuity less than 20/40, which would preclude completion of the assessments;
- Not meeting MRI eligibility (e.g. metal implants, pacemaker, etc.)
- Clinically diagnosed vestibular dysfunction;
- Unwilling or unable to do an over-ground version of the uneven terrain task without assistive device;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brain activity during walking
Time frame: Baseline up to 42 months
Changes in brain activity during complex walking (uneven terrain), assessed longitudinally for up to 3.5 years
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 17 Jul 2025.
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.
David Clark, ScD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Effect of Age-related Changes in the Brain on Walking Ability, run by University of Florida 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 9 inclusion and 35 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 17 Jul 2025. 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. 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?
Brain activity during walking (time frame: Baseline up to 42 months). 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 17 Jul 2025.