Perturbation Training Reduces Falls in People With AD

NCT ID: NCT05205980

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-28

Study Completion Date

2026-10-30

Brief Summary

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

Detailed Description

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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).

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
The assessor will be blinded to the group assignment of each participant.

Study Groups

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Training group

This arm will receive a single-session perturbation training treatment on a treadmill under the protection of a safety harness.

Group Type EXPERIMENTAL

Perturbation training

Intervention Type BEHAVIORAL

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

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.

Group Type SHAM_COMPARATOR

Perturbation training

Intervention Type BEHAVIORAL

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

Interventions

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Perturbation training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 Monteral 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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Alzheimer's Association

OTHER

Sponsor Role collaborator

Georgia State University

OTHER

Sponsor Role lead

Responsible Party

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Feng Yang, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Feng Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgia State University

Locations

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Reminiscent

Valdosta, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Feng Yang, PhD

Role: CONTACT

404-413-8357

Facility Contacts

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Debra Tann, Ed.D.

Role: primary

229-415-3333

Other Identifiers

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H22487

Identifier Type: -

Identifier Source: org_study_id

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