Vestibular Physical Therapy for People With Alzheimer Disease
VPT in AD
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2019
CompletedFirst Posted
Study publicly available on registry
March 25, 2019
CompletedStudy Start
First participant enrolled
May 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedMarch 24, 2020
March 1, 2020
8 months
March 21, 2019
March 23, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (9)
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)
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)
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)
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)
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)
- +4 more secondary outcomes
Study Arms (1)
Vestibular Physical Therapy
EXPERIMENTALBalance, Gaze Stabilization, Habituation, and Walking exercises
Interventions
Balance, Gaze Stabilization, Habituation, and Walking exercises
Eligibility Criteria
You may qualify if:
- mild-AD diagnosis
- complaints or observation of gat disturbance
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- Johns Hopkins Universitycollaborator
Study Sites (1)
University of Pittsburgh Alzheimer Disease Research Center
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brooke N Klatt, PhD, PT
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Postdoctoral Fellow
Study Record Dates
First Submitted
March 21, 2019
First Posted
March 25, 2019
Study Start
May 10, 2019
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
March 24, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share