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NCT Number: NCT05205980

Perturbation Training Reduces Falls in People With Alzheimer's Disease (AD)

This study will examine the overall capacity of people with Alzheimer's disease learning fall-resistant skills from perturbation training.

Recruiting

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Key information

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reminiscent

Valdosta, Georgia, 31602, United States

Location status: Recruiting

Location contact

Debra Tann, Ed.D.

CONTACT

229-415-3333

About this study

Falls can cause injury and death in older adults. Those with Alzheimer's disease are at an even higher fall risk. Our goal is to test if people with mild Alzheimer's disease can learn fall prevention skills from the exposure to large-scale perturbations on a treadmill. Two groups with mild Alzheimer's disease will be enrolled. One group will attend a perturbation training session while the other group receives no training. Groups will then be exposed to perturbations on the ground immediately and three or six months after the training. Over six months after the training, daily-living falls will be tracked for both groups. The falls following the perturbations in the lab and daily-living all-cause falls will be compared between groups to test our specific aims: 1) to test if people with Alzheimer's disease can adapt to large-scale external perturbations and learn fall resistant motor skills; 2) to inspect whether people with Alzheimer's disease can retain motor skills learned in Aim 1; and 3) to determine if people with Alzheimer's disease can generalize fall resistant skills to different contexts (treadmill to overground, inside the lab to outside the lab).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be at least 65 years old;
  • Participants have a clinical diagnosis of probable AD;
  • Participants can read and understand English;
  • Participants must be able to walk independently at least 25 feet;
  • Participants must be able to stand independently for at least 30 seconds;
  • Participants must have a Montreal Cognitive Assessment score of 11-21 or Mini Mental Status Examination score between 18 and 23.

Exclusion criteria

  • Individuals have ever experienced perturbation training;
  • Individuals have hypotension or uncontrolled hypertension;
  • Individuals exhibit osteoporosis;
  • Participants suffer from coexisting psychiatric disorders, or other neurological conditions, or injuries, etc.

Treatment and study plan

Perturbation Training

Behavioral

Participants will experience repeated perturbations mixed with non-perturbed trials on the treadmill with the protection by a harness.

Primary outcomes

  1. Lab-induced faller rate

    Time frame: 6 months

    The outcome of each perturbation trial will be determined as a fall if the peak load cell force exceeds 30% of the body weight. The load cell records the force applied to the human body by the safety harness system after a perturbation. The lab-induced faller rate will be calculated as the ratio of the number of fallers to the number of participants within each group.

Secondary outcomes

  1. Dynamic stability

    Time frame: 6 months

    Dynamic stability will be calculated for each perturbation trial based on the kinematics of the body's center of mass relative to the base of support.

  2. Number of prospective fall incident

    Time frame: 6 months

    The number of all cause falls in daily-living activities after the training session will be recorded for each participant.

Other outcomes

  1. Berg Balance Scale

    Time frame: 6 months

    Berg balance scale will be used to objectively determine a participant' ability (or inability) to safely balance during a series of preset tasks. The score of the Berg Balance Scale is between 0 and 56 with a higher value indicating a better balance ability.

  2. Mobility

    Time frame: 6 months

    Functional mobility will be assessed using the Timed-Up-and-Go test. The time used to complete the test will be recorded. The shorter the time, the better mobility.

  3. Muscle strength

    Time frame: 6 months

    Strength capacity will be tested on the knee joint as the maximum strength the knee joint can produce. The measurement will be taken on an isokinetic dynamometer.

  4. Pressure sensation level

    Time frame: 6 months

    The tactile sensation level at the dominant sole will be determined as the number of sites where the participant can feel the pressure produced by the monofilament.

  5. Posturography test

    Time frame: 6 months

    This test will be done when the participant is standing on a pair of force plates. The center of pressure movement will be calculated from the ground reaction force measured by the force plates. The center of pressure excursion in the anteroposterior and mediolateral directions will be calculated.

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Yang, PhD

CONTACT

[email protected]

404-413-8357

Sponsors and collaborators

Lead sponsor

Georgia State University

Other

Collaborators

  • Alzheimer's Association
  • National Institutes of Health (NIH)

Registry information

Official study title

Motor Learning of Fall Resistant Skills From Laboratory-induced Falling Among People With Mild Alzheimer's Disease

Acronym: STAD

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 25, 2022
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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