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

NCT05205980 | Recruiting DMC

• 1 other identifier: H22487
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Dynamic stability

  6 months

• Number of prospective fall incident

  6 months

Other Outcomes (5)

• Berg Balance Scale

  6 months

• Mobility

  6 months

• Muscle strength

  6 months

Study Arms (2)

Training group

EXPERIMENTAL

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

Behavioral: Perturbation training

Control group

SHAM COMPARATOR

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

Interventions

Perturbation training BEHAVIORAL

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

Control group; Training group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Georgia State University: lead
• National Institutes of Health (NIH): collaborator
• Alzheimer's Association: collaborator

Study Sites (1)

Reminiscent

Valdosta, Georgia, 31602, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Feng Yang, PhD

  Georgia State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Yang, PhD

CONTACT

404-413-8357; fyang@gsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor will be blinded to the group assignment of each participant.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 25, 2022
• Study Start: April 28, 2023
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)