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Vestibular Physical Therapy for People With Alzheimer Disease (VPT in AD)

Primary Purpose

Vestibular Diseases, Alzheimer Disease, Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vestibular Physical Therapy
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Diseases

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh Alzheimer Disease Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vestibular Physical Therapy

Arm Description

Balance, Gaze Stabilization, Habituation, and Walking exercises

Outcomes

Primary Outcome Measures

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).
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
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
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

Secondary Outcome Measures

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)
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.
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.
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.
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
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.
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.
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.
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.

Full Information

First Posted
March 21, 2019
Last Updated
March 23, 2020
Sponsor
University of Pittsburgh
Collaborators
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT03887923
Brief Title
Vestibular Physical Therapy for People With Alzheimer Disease
Acronym
VPT in AD
Official Title
Vestibular Physical Therapy for People With Alzheimer Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Diseases, Alzheimer Disease, Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vestibular Physical Therapy
Arm Type
Experimental
Arm Description
Balance, Gaze Stabilization, Habituation, and Walking exercises
Intervention Type
Behavioral
Intervention Name(s)
Vestibular Physical Therapy
Other Intervention Name(s)
modified-Vestibular Physical Therapy
Intervention Description
Balance, Gaze Stabilization, Habituation, and Walking exercises
Primary Outcome Measure Information:
Title
Tolerability of Vestibular Physical Therapy in people with Alzheimer Disease: number of times modifications are needed to be made
Description
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).
Time Frame
8 weeks
Title
Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in balance performance for people with Alzheimer Disease; Gait velocity
Description
Gait velocity: preferred walking speed will be recorded over 10-meter distance and is measured in meters/second
Time Frame
10 weeks (the outcomes will be obtained pre- and post-training)
Title
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
Description
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
Time Frame
10 weeks (the outcomes will be obtained pre- and post-training)
Title
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
Description
Mini Balance Evaluation Systems Test: assesses anticipatory postural adjustment, reactive postural control, sensory orientation, and dynamic gait with a total score of 28
Time Frame
10 weeks (the outcomes will be obtained pre- and post-training)
Secondary Outcome Measure Information:
Title
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
Description
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)
Time Frame
10 weeks (the outcomes will be obtained pre- and post-training)
Title
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
Description
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.
Time Frame
10 weeks (the outcomes will be obtained pre- and post-training)
Title
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
Description
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.
Time Frame
10 weeks (the outcomes will be obtained pre- and post-training)
Title
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
Description
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.
Time Frame
10 weeks (the outcomes will be obtained pre- and post-training)
Title
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
Description
Digit Span Forward & Backward: assesses memory by recording how many digits the participant can repeat back in the correct order immediately after presentation
Time Frame
10 weeks (the outcomes will be obtained pre- and post-training)
Title
Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Letter Fluency
Description
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.
Time Frame
10 weeks (the outcomes will be obtained pre- and post-training)
Title
Preliminary efficacy of an 8-week home-based Vestibular Physical Therapy program on change in cognitive function for people with Alzheimer Disease: Category Fluency
Description
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.
Time Frame
10 weeks (the outcomes will be obtained pre- and post-training)
Title
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
Description
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.
Time Frame
10 weeks (the outcomes will be obtained pre- and post-training)
Title
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
Description
Benton Visual Retention Test: assesses visual perception and visual memory by asking participants to reproduce 10 different individual designs after a 10-second exposure.
Time Frame
10 weeks (the outcomes will be obtained pre- and post-training)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brooke N Klatt, PhD, PT
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Alzheimer Disease Research Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Vestibular Physical Therapy for People With Alzheimer Disease

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