Vestibular Physical Therapy for People With Alzheimer Disease

Study Overview
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Brief Summary
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The purpose of this study is to assess the tolerability and preliminary efficacy of an 8-week home-based vestibular physical therapy program in people with cognitive impairment.

Detailed Description
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This project uses a novel non-pharmacological treatment to improve balance and reduce falls in patients with Alzheimer Disease (AD) using a conceptual framework that combines current vestibular physical therapy (VPT) practice guidelines with the latest motor learning theories for cognitively-impaired patients. The modified VPT protocol for AD patients was developed by experts in VPT and motor learning in AD and will be tested. This pilot study will provide much-needed data about whether VPT can be adapted for patients with AD, and whether VPT shows promise in improving or stabilizing balance, spatial cognition, and gait function in patients with AD.

Official Title
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Vestibular Physical Therapy for People With Alzheimer Disease

Conditions
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Vestibular Diseases, Alzheimer Disease, Cognitive Impairment

Intervention / Treatment
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* Behavioral: Vestibular Physical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mild-AD diagnosis complaints or observation of gat disturbance Exclusion Criteria: inability to stand for 3 minutes without rest recent lower extremity fractures/severe sprains (within last six months) incapacitating back or lower extremity pain confounding neurologic or neuromuscular disorders presence of benign paroxysmal positional vertigo pain elicited during cervical range of motion or limited cervical range of motion

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vestibular Physical Therapy<br>Balance, Gaze Stabilization, Habituation, and Walking exercises | Behavioral: Vestibular Physical Therapy<br>* Balance, Gaze Stabilization, Habituation, and Walking exercises<br>* Other names: modified-Vestibular Physical Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of Vestibular Physical Therapy in people with Alzheimer Disease: number of times modifications are needed to be made | The ability to perform the tasks within VPT will be monitored during each exercise within all eight training sessions. The number of times modifications are needed to be made to the protocol will be recorded (for example, the number of times the participant needs cuing to attend to the exercise for gaze stabilization which requires constant head movement for the 30-second exercise trial will be recorded). | 8 weeks | 
| Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in balance performance for people with Alzheimer Disease; Gait velocity | Gait velocity: preferred walking speed will be recorded over 10-meter distance and is measured in meters/second | 10 weeks (the outcomes will be obtained pre- and post-training) | 
| Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in balance performance for people with Alzheimer Disease: Four Square Step Test | Four Square Step Test: dynamic balance, spatial, & sequencing skills will be assessed as participants step forward, backward, and sideways over a low obstacle and is measured by time (seconds) to complete the test | 10 weeks (the outcomes will be obtained pre- and post-training) | 
| Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in balance performance for people with Alzheimer Disease: Mini Balance Evaluation Systems Test | Mini Balance Evaluation Systems Test: assesses anticipatory postural adjustment, reactive postural control, sensory orientation, and dynamic gait with a total score of 28 | 10 weeks (the outcomes will be obtained pre- and post-training) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Montreal Cognitive Assessment | Montreal Cognitive Assessment: assesses several cognitive domains and serves as a screening tool for detecting cognitive impairment with scores ranging from 0-30 (score over 26 is considered normal) | 10 weeks (the outcomes will be obtained pre- and post-training) | 
| Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Money Road Map Test | Money Road Map Test assesses egocentric mental rotation in space by recording the total number of errors for right-left discrimination of mental rotation tasks. | 10 weeks (the outcomes will be obtained pre- and post-training) | 
| Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Trail Making Test A | Trail Making Test A: assesses executive function by recording the time to accurately connect a sequence of 25 consecutive targets on a sheet of paper. | 10 weeks (the outcomes will be obtained pre- and post-training) | 
| Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Trail Making Test B | Trail Making Test B: assesses visual attention and task switching by recording the time to accurately connect a sequence of 25 consecutive targets alternating between numbers and letters on a sheet of paper. | 10 weeks (the outcomes will be obtained pre- and post-training) | 
| Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Digit Span Forward & Backward | Digit Span Forward & Backward: assesses memory by recording how many digits the participant can repeat back in the correct order immediately after presentation | 10 weeks (the outcomes will be obtained pre- and post-training) | 
| Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Letter Fluency | Letter Fluency: assesses verbal fluency by recording how many words that the participant can produce that begin with a certain letter in a 60-second timeframe. | 10 weeks (the outcomes will be obtained pre- and post-training) | 
| Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Category Fluency | Category Fluency: assesses verbal fluency by recording how many words that the participant can produce that are within a certain category in a 60-second timeframe. | 10 weeks (the outcomes will be obtained pre- and post-training) | 
| Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Digit Symbol Substitution | Digit Symbol Substitution assesses cognitive functioning by seeing how many correct digit-symbol pairs the participant can record in 90 seconds using a nine pair options. | 10 weeks (the outcomes will be obtained pre- and post-training) | 
| Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Benton Visual Retention Test | Benton Visual Retention Test: assesses visual perception and visual memory by asking participants to reproduce 10 different individual designs after a 10-second exposure. | 10 weeks (the outcomes will be obtained pre- and post-training) |