Clinical trial NCT03887923: Vestibular Physical Therapy for People With Alzheimer Disease
Official title: Vestibular Physical Therapy for People With Alzheimer Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Diseases
Alzheimer Disease
Cognitive Impairment
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2019-03-25
Enrollment: 5
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Tolerability of Vestibular Physical Therapy in people with Alzheimer Disease: number of times modifications are needed to be made
timeFrame: 8 weeks
measure: Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in balance performance for people with Alzheimer Disease; Gait velocity
timeFrame: 10 weeks (the outcomes will be obtained pre- and post-training)
measure: 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
timeFrame: 10 weeks (the outcomes will be obtained pre- and post-training)
measure: 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
timeFrame: 10 weeks (the outcomes will be obtained pre- and post-training)
Secondary outcomes:
measure: 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
timeFrame: 10 weeks (the outcomes will be obtained pre- and post-training)
measure: 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
timeFrame: 10 weeks (the outcomes will be obtained pre- and post-training)
measure: 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
timeFrame: 10 weeks (the outcomes will be obtained pre- and post-training)
measure: 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
timeFrame: 10 weeks (the outcomes will be obtained pre- and post-training)
measure: 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
timeFrame: 10 weeks (the outcomes will be obtained pre- and post-training)
measure: Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Letter Fluency
timeFrame: 10 weeks (the outcomes will be obtained pre- and post-training)
measure: Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Category Fluency
timeFrame: 10 weeks (the outcomes will be obtained pre- and post-training)
measure: 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
timeFrame: 10 weeks (the outcomes will be obtained pre- and post-training)
measure: 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
timeFrame: 10 weeks (the outcomes will be obtained pre- and post-training)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Alzheimer Disease Research Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Brooke N Klatt, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: