NCT06484244 · Emory University
Locomotion Adaptation Deficits in Older Adults With Mild Cognitive Impairment and Alzheimers Disease
What this study is about
In people with Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD), reduced capacity for locomotor adaptation is a fundamental but poorly understood mechanism that can be a sensitive biomarker of cognitive-motor impairments. It is also an important therapeutic target for exercise-based interventions to improve walking function.
View original scientific description
In people with Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD), reduced capacity for locomotor adaptation is a fundamental but poorly understood mechanism that can be a sensitive biomarker of cognitive-motor impairments. It is also an important therapeutic target for exercise-based interventions to improve walking function. The overall goal of this study is to understand the effects of MCI and AD on locomotor adaptation and walking function.
Interventions
OTHER
5 Sessions of Split-belt Treadmill-based Locomotor Adaptation
Participants will complete 5 sessions of split-belt treadmill-based locomotor adaptation. The split-belt instrumented treadmill allows the two belt speeds to be operated independently, enabling different belt speeds for each leg. The split-belt walking assessment will consist of 3 phases: baseline phase in which the belts operated at the same speed (Pre-tied, 2-minutes), a phase in which the belts operated at different speeds (Split-belt, 15-minutes), and a final phase in which the belts operated at the same speed (Post-tied, 4-minutes).
Primary outcome measures
Change in Adaptation Magnitude Assessed as Peak Step Length Symmetry
Time frame: Baseline (Pre-training), Week 2 (Post-training)
Locomotor adaptation is the ability to adjust stepping movements to changing environmental demands via trial-and-error processing. Step length symmetry data from the split-belt phase will be used to evaluate each individual's locomotor adaptation magnitude capacity by assessing the peak step length symmetry in the early adaptation period.
Change in Adaptation Rate Assessed as the Number of Steps to Reach Step Symmetry
Time frame: Baseline (Pre-training), Week 2 (Post-training)
The adaptation rate is assessed as the number of steps required to reach a plateau in step symmetry during late adaptation.
Change in 10-Meter Overground Walk Test
Time frame: Baseline (Pre-training), Week 2 (Post-training)
Gait speed is assessed with the 10-Meter Overground Walk Test. The 10-Meter Overground Walk Test is used to assess walking speed over a short distance. A 10 meter (m) walkway over solid flooring will be measured and marked at start (0 m), 2 m, 8 m, and finish (10 m). Participants will be asked to complete three trials of the 10 m walk at their comfortable self-selected walking speed. The time for the three trials for each speed will be averaged and gait speed converted to meters/second.
Change in 6-Minute Walk Test
Time frame: Baseline (Pre-training), Week 2 (Post-training)
Gait endurance is assessed with the 6-minute walk test. The 6-Minute Walk Test is a sub-maximal exercise test used to assess walking endurance. A walkway of a minimum 12 m over solid flooring will be measured and marked with a turn-around marked at either end of the walkway. The turn-around points will be approximately 49 inches (124 cm) wide with clear markings. A chair will be placed at one end of the walkway to allow for seated rest breaks if necessary. Prior to administering the test, the participant will be seated in the chair resting. The participant will then be asked to walk as far as possible in 6 minutes along the walkway using scripted instruction (see below). The distance (in meters) will be calculated by multiplying the number of total laps by 12 meters and adding the distance of the partial lap completed at the time the test ended.
Change in Montreal Cognitive Assessment (MoCA) Score
Time frame: Baseline (Pre-training), Week 2 (Post-training)
MoCA is an instrument to screen for mild cognitive dysfunction, assessing the cognitive domains of attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Total scores range from 0 to 30 with higher scores indicating better cognitive function. A normal score is considered to be 26 or higher.
Change in NIH-EXAMINER n-back Task Accuracy
Time frame: Baseline (Pre-training), Week 2 (Post-training)
The NIH-EXAMINER assesses spatial working memory with the n-back tasks. The 1-back involves maintaining and updating one location at a time while two locations at a time are maintained and updated with the 2-back. During the n-back tasks, participants view a series of stimuli and press a button when a particular stimulus has been previously shown. The 1-back consists of one block of 30 trials, ten of which match the location of the previous square, and 20 that are in a different location. The 2-back consists of one block of 90 trials, 30 of which match the location of the square two before, and 60 that are in a different location. The score is calculated as the percentage of correct responses.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Atlanta, Georgia
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
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Data: ClinicalTrials.gov · synced Mar 2, 2026 · Source of record for eligibility and locations