VPT in AD: Vestibular Physical Therapy for People With Alzheimer Disease

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT03887923
Collaborator
Johns Hopkins University (Other)
5
1
1
7.7
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Vestibular Physical Therapy
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Vestibular Physical Therapy for People With Alzheimer Disease
Actual Study Start Date :
May 10, 2019
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vestibular Physical Therapy

Balance, Gaze Stabilization, Habituation, and Walking exercises

Behavioral: Vestibular Physical Therapy
Balance, Gaze Stabilization, Habituation, and Walking exercises
Other Names:
  • modified-Vestibular Physical Therapy
  • Outcome Measures

    Primary Outcome Measures

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

    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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pittsburgh Alzheimer Disease Research Center Pittsburgh Pennsylvania United States 15213

    Sponsors and Collaborators

    • University of Pittsburgh
    • Johns Hopkins University

    Investigators

    • Principal Investigator: Brooke N Klatt, PhD, PT, University of Pittsburgh

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Brooke Klatt, Postdoctoral Fellow, University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT03887923
    Other Study ID Numbers:
    • STUDY18120038
    First Posted:
    Mar 25, 2019
    Last Update Posted:
    Mar 24, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 24, 2020