Locomotion Adaptation Deficits in Older Adults With Mild Cognitive Impairment and Alzheimers Disease

NCT06484244 | Recruiting DMC

• 2 other identifiers: STUDY00006698R21AG084231
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimers Disease; Mild Cognitive Impairment

Keywords

walking function; gait disturbances; gait variability; locomotor adaptation

Outcome Measures

Primary Outcomes (6)

• Change in Adaptation Magnitude Assessed as Peak Step Length Symmetry

  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.

  Baseline (Pre-training), Week 2 (Post-training)

• Change in Adaptation Rate Assessed as the Number of Steps to Reach Step Symmetry

  The adaptation rate is assessed as the number of steps required to reach a plateau in step symmetry during late adaptation.

  Baseline (Pre-training), Week 2 (Post-training)

• Change in 10-Meter Overground Walk Test

  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.

  Baseline (Pre-training), Week 2 (Post-training)

• Change in 6-Minute Walk Test

  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.

  Baseline (Pre-training), Week 2 (Post-training)

• Change in Montreal Cognitive Assessment (MoCA) Score

  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.

  Baseline (Pre-training), Week 2 (Post-training)

• Change in NIH-EXAMINER n-back Task Accuracy

  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.

  Baseline (Pre-training), Week 2 (Post-training)

Secondary Outcomes (10)

• Change in De-adaptation Magnitude Assessed as Peak Step Length Symmetry

  Baseline (Pre-training), Week 2 (Post-training)

• Change in De-adaptation Rate Assessed as the Number of Steps to Reach Step Symmetry

  Baseline (Pre-training), Week 2 (Post-training)

• Change in Timed Up and Go (TUG) Test

  Baseline (Pre-training), Week 2 (Post-training)

• Change in Falls History

  Baseline (Pre-training), Week 2 (Post-training)

• Change in Stride Duration

  Baseline (Pre-training), Week 2 (Post-training)

Study Arms (2)

Split-beltTreadmill-based Locomotor Adaptation in Older Adults with MCI

EXPERIMENTAL

Older adults with mild cognitive impairment (MCI) complete 5 split-belt treadmill walking exercise sessions over a 2-week period.

Other: 5 Sessions of Split-belt Treadmill-based Locomotor Adaptation

Split-beltTreadmill-based Locomotor Adaptation in Older Adults with AD

EXPERIMENTAL

Older adults with Alzheimer's Disease (AD) complete 5 split-belt treadmill walking exercise sessions over a 2-week period.

Other: 5 Sessions of Split-belt Treadmill-based Locomotor Adaptation

Interventions

5 Sessions of Split-belt Treadmill-based Locomotor Adaptation OTHER

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).

Split-beltTreadmill-based Locomotor Adaptation in Older Adults with AD; Split-beltTreadmill-based Locomotor Adaptation in Older Adults with MCI

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• Emory University: lead

Study Sites (1)

Emory Rehabilitation Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Mobility Limitation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Trisha Kesar, PT, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trisha Kesar, PT, PhD

CONTACT

(404) 712-5803; tkesar@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: July 22, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: The research community will have access to the data when the award for this study ends and findings from this study are published. The data will be preserved indefinitely and is subject to decisions by DANDI regarding how long data will be preserved.
• Access Criteria: The research community will have unrestricted access to the data with an account through DANDI.

Locations

US (1)