Clinical trial NCT05205980: Perturbation Training Reduces Falls in People With AD
Official title: Motor Learning of Fall Resistant Skills From Laboratory-induced Falling Among People With Mild Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Georgia State University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Alzheimer's Association
First posted: 2022-01-25
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Lab-induced faller rate
timeFrame: 6 months
Secondary outcomes:
measure: Dynamic stability
timeFrame: 6 months
measure: Number of prospective fall incident
timeFrame: 6 months
Other outcomes:
measure: Berg Balance Scale
timeFrame: 6 months
measure: Mobility
timeFrame: 6 months
measure: Muscle strength
timeFrame: 6 months
measure: Pressure sensation level
timeFrame: 6 months
measure: Posturography test
timeFrame: 6 months
Locations:
city: Valdosta
country: United States
facility: Reminiscent
state: Georgia
Study officials:
affiliation: Georgia State University
name: Feng Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References: