Walking adaptation problems in older adults with mild cognitive impairment or Alzheimer's disease
Locomotion Adaptation Deficits in Older Adults With Mild Cognitive Impairment and Alzheimers Disease
This study will test whether five sessions of split-belt treadmill training can improve walking adaptability and everyday walking function in older adults with MCI or Alzheimer's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 50 Years to 90 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT06484244 on ClinicalTrials.gov |
What this trial studies
The researchers will compare locomotor adaptation and gait performance in older adults diagnosed with amnestic MCI or Alzheimer's disease using repeated split-belt treadmill sessions. Participants will complete five sessions of split-belt treadmill-based locomotor adaptation while investigators measure gait variables, adaptation magnitude, and cognitive-motor performance. The protocol includes standardized cognitive and mobility testing to link changes in walking adaptation with cognitive status and fall-risk-related gait features. All testing and training occur in person at a rehabilitation clinic with participants selected based on neurologist-confirmed diagnoses.
Who should consider this trial
Good fit: Ideal candidates are older adults with a neurologist-confirmed diagnosis of amnestic MCI (per ADNI criteria) or Alzheimer's disease who can safely walk on a treadmill and tolerate repeated in-person sessions.
Not a fit: Patients with severe dementia, significant inability to walk or stand safely on a treadmill, unstable medical conditions, or other major mobility-limiting comorbidities are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could improve walking adaptability, reduce fall risk, and help maintain mobility and independence for people with MCI or Alzheimer's disease.
How similar studies have performed: Split-belt treadmill interventions have improved gait adaptation in stroke survivors and some older adult groups, but applying this approach specifically to MCI and Alzheimer's populations is relatively novel and less tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * AD and MCI will be defined through formal diagnosis provided by a board-certified Neurologist. Amnestic MCI will be defined using the AD Neuroimaging Initiative (ADNI) criteria. All MCI participants in ADNI are required to have an amnestic subtype defined as: * Subjective memory concern or a memory problem noted by their partner * Abnormal memory function documented by a specified education adjusted cutoff score on the delayed paragraph recall of the Anna Thompson story of the Logical Memory subtest from the Wechsler Memory Scale-Revised * Mini-Mental State Exam (MMSE) score between 20 and 26 (inclusive). Exceptions may be made for subjects with less than 8 years of education at the discretion of the PI. (iv) Single or multi-domain amnestic MCI (both subtypes are at high risk for progression to AD) * Clinical Dementia Rating (CDR) = 0.5 (Memory Box score must be at least 0.5) * General functional performance sufficiently preserved * Evidence of impaired executive function based on Montreal Cognitive Assessment (MoCA) score 13-17 * Able to walk 10 or more feet without an assistive device * Completed six grades of education or has a good work history (sufficient to exclude intellectual disabilities) * Not hospitalized within the last 60 days Exclusion Criteria: * Acute medical illness requiring hospitalization * Uncontrolled congestive heart failure * History of stroke * Inability to perform study procedures * Medical or physical conditions that would preclude participation or walking (e.g., severe arthritis or mobility problems, uncontrolled hypertension or diabetes, renal failure, history of angina with activity) * On medications that could adversely affect cognition, eg: antipsychotics, opioids, stimulants, chemotherapy, anti-parkinsonian drugs (eg Levodopa), neurologic prescriptions to treat Multiple sclerosis and/or Parkinson's * Psychotic disorders * Confounding neurologic conditions (e.g., active central nervous system (CNS) opportunistic infections, seizure disorders, head injury with loss of consciousness \>30 minutes, intracranial neoplasms, stroke with neurological or neuropsychiatric sequelae) * Substance Use Disorder, Major Depressive and Generalized Anxiety Disorders within six months of evaluation
Where this trial is running
Atlanta, Georgia
- Emory Rehabilitation Hospital — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Trisha Kesar, PT, PhD — Emory University
- Study coordinator: Trisha Kesar, PT, PhD
- Email: tkesar@emory.edu
- Phone: (404) 712-5803
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.