Recruiting

Locomotor Adaptation

Sponsor:

Emory University

Code:

NCT06484244

Conditions

Alzheimers Disease

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

5 Sessions of Split-belt Treadmill-based Locomotor Adaptation

Study Details

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

Study ID

NCT06484244

Start date

Jul 22, 2025

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

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

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

Interventions

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 measure

  • Change in Adaptation Magnitude Assessed as Peak Step Length Symmetry [ Time Frame: Baseline (Pre-training), Week 2 (Post-training) ]
  • Change in Adaptation Rate Assessed as the Number of Steps to Reach Step Symmetry [ Time Frame: Baseline (Pre-training), Week 2 (Post-training) ]
  • Change in 10-Meter Overground Walk Test [ Time Frame: Baseline (Pre-training), Week 2 (Post-training) ]
  • Change in 6-Minute Walk Test [ Time Frame: Baseline (Pre-training), Week 2 (Post-training) ]
  • Change in Montreal Cognitive Assessment (MoCA) Score [ Time Frame: Baseline (Pre-training), Week 2 (Post-training) ]
  • Change in NIH-EXAMINER n-back Task Accuracy [ Time Frame: Baseline (Pre-training), Week 2 (Post-training) ]

Central Contacts and Locations

Central contacts

Trisha Kesar, PT, PhD

(404) 712-5803tkesar@emory.edu

Locations

Emory Rehabilitation Hospital

Recruiting

Atlanta, Georgia, United States, 30322

More Information

Sponsor

Emory University

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Keywords

  • walking function
  • gait disturbances
  • gait variability
  • locomotor adaptation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-03-02.