Perturbation Training Reduces Falls in People With AD (STAD)
Primary Purpose
Alzheimer Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Perturbation training
Sponsored by
About this trial
This is an interventional prevention trial for Alzheimer Disease
Eligibility Criteria
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 have fallen at least once in the past 6 months;
- Participants must be able to stand independently for at least 30 seconds;
- Participants must have a 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.
Sites / Locations
- ReminiscentRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Training group
Control group
Arm Description
This arm will receive a single-session perturbation training treatment on a treadmill under the protection of a safety harness.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05205980
First Posted
December 15, 2021
Last Updated
July 18, 2023
Sponsor
Georgia State University
Collaborators
National Institutes of Health (NIH), Alzheimer's Association
1. Study Identification
Unique Protocol Identification Number
NCT05205980
Brief Title
Perturbation Training Reduces Falls in People With AD
Acronym
STAD
Official Title
Motor Learning of Fall Resistant Skills From Laboratory-induced Falling Among People With Mild Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgia State University
Collaborators
National Institutes of Health (NIH), Alzheimer's Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will examine the overall capacity of people with Alzheimer's disease learning fall-resistant skills from 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The assessor will be blinded to the group assignment of each participant.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Training group
Arm Type
Experimental
Arm Description
This arm will receive a single-session perturbation training treatment on a treadmill under the protection of a safety harness.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Perturbation training
Intervention Description
Participants will experience repeated perturbations mixed with non-perturbed trials on the treadmill with the protection by a harness.
Primary Outcome Measure Information:
Title
Lab-induced faller rate
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Dynamic stability
Description
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.
Time Frame
6 months
Title
Number of prospective fall incident
Description
The number of all cause falls in daily-living activities after the training session will be recorded for each participant.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Berg Balance Scale
Description
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.
Time Frame
6 months
Title
Mobility
Description
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.
Time Frame
6 months
Title
Muscle strength
Description
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.
Time Frame
6 months
Title
Pressure sensation level
Description
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.
Time Frame
6 months
Title
Posturography test
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Yang, PhD
Phone
404-413-8357
Email
fyang@gsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Yang, PhD
Organizational Affiliation
Georgia State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reminiscent
City
Valdosta
State/Province
Georgia
ZIP/Postal Code
31602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debra Tann, Ed.D.
Phone
229-415-3333
12. IPD Sharing Statement
Plan to Share IPD
No
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Perturbation Training Reduces Falls in People With AD
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