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

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

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

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease
• Intervention / Treatment: Behavioral: Perturbation training

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Feng Yang, PhD; Phone Number: 404-413-8357; Email: fyang@gsu.edu

Study Locations

• United States
  • Georgia
    • Valdosta, Georgia, United States, 31602
      • Recruiting
      • Reminiscent
      • Contact: Debra Tann, Ed.D.; Phone Number: 229-415-3333

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training group; This arm will receive a single-session perturbation training treatment on a treadmill under the protection of a safety harness.	Behavioral: Perturbation training; Participants will experience repeated perturbations mixed with non-perturbed trials on the treadmill with the protection by a harness.
Sham Comparator: Control group; This arm will not receive perturbation training but will go through harnessed walking on the same treadmill for the same time as the other group.	Behavioral: Perturbation training; Participants will experience repeated perturbations mixed with non-perturbed trials on the treadmill with the protection by a harness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lab-induced faller rate	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of prospective fall incident	The number of all cause falls in daily-living activities after the training session will be recorded for each participant.	6 months
Dynamic stability	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.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale	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.	6 months
Mobility	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.	6 months
Muscle strength	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.	6 months
Pressure sensation level	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.	6 months
Posturography test	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.	6 months

Collaborators and Investigators

• Sponsor: Georgia State University
• Collaborators: National Institutes of Health (NIH); Alzheimer's Association
• Investigators: Principal Investigator: Feng Yang, PhD, Georgia State University

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2023
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: H22487

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No