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Completed

NCT Number: NCT03887923

Vestibular Physical Therapy for People With Alzheimer Disease

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.

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Key information

Conditions

Vestibular Diseases Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Dementia Ear Diseases Labyrinth Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Otorhinolaryngologic Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Alzheimer Disease Research Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vestibular physical therapy

Behavioral

Balance, Gaze Stabilization, Habituation, and Walking exercises

Other names: modified-Vestibular Physical Therapy

Primary outcomes

  1. Tolerability of Vestibular Physical Therapy in people with Alzheimer Disease: number of times modifications are needed to be made

    Time frame: 8 weeks

    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).

  2. Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in balance performance for people with Alzheimer Disease; Gait velocity

    Time frame: 10 weeks (the outcomes will be obtained pre- and post-training)

    Gait velocity: preferred walking speed will be recorded over 10-meter distance and is measured in meters/second

  3. 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

    Time frame: 10 weeks (the outcomes will be obtained pre- and post-training)

    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

  4. 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

    Time frame: 10 weeks (the outcomes will be obtained pre- and post-training)

    Mini Balance Evaluation Systems Test: assesses anticipatory postural adjustment, reactive postural control, sensory orientation, and dynamic gait with a total score of 28

Secondary outcomes

  1. 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

    Time frame: 10 weeks (the outcomes will be obtained pre- and post-training)

    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)

  2. 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

    Time frame: 10 weeks (the outcomes will be obtained pre- and post-training)

    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.

  3. 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

    Time frame: 10 weeks (the outcomes will be obtained pre- and post-training)

    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.

  4. 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

    Time frame: 10 weeks (the outcomes will be obtained pre- and post-training)

    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.

  5. 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

    Time frame: 10 weeks (the outcomes will be obtained pre- and post-training)

    Digit Span Forward & Backward: assesses memory by recording how many digits the participant can repeat back in the correct order immediately after presentation

  6. Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Letter Fluency

    Time frame: 10 weeks (the outcomes will be obtained pre- and post-training)

    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.

  7. Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Category Fluency

    Time frame: 10 weeks (the outcomes will be obtained pre- and post-training)

    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.

  8. 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

    Time frame: 10 weeks (the outcomes will be obtained pre- and post-training)

    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.

  9. 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

    Time frame: 10 weeks (the outcomes will be obtained pre- and post-training)

    Benton Visual Retention Test: assesses visual perception and visual memory by asking participants to reproduce 10 different individual designs after a 10-second exposure.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Johns Hopkins University

Registry information

Acronym: VPT in AD

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 25, 2019
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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