Perturbation Training Reduces Falls in People With AD

Study Overview
=================
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).

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

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Behavioral: Perturbation training


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training group<br>This arm will receive a single-session perturbation training treatment on a treadmill under the protection of a safety harness. | Behavioral: Perturbation training<br>* Participants will experience repeated perturbations mixed with non-perturbed trials on the treadmill with the protection by a harness.<br>|
| Sham Comparator: Control group<br>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<br>* Participants will experience repeated perturbations mixed with non-perturbed trials on the treadmill with the protection by a harness.<br>|

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 |
| --- | --- | --- |
| 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 | 
| 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 |