- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03887923
Vestibular Physical Therapy for People With Alzheimer Disease (VPT in AD)
March 23, 2020 updated by: Brooke Klatt, University of Pittsburgh
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Alzheimer Disease Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Vestibular Physical Therapy
Balance, Gaze Stabilization, Habituation, and Walking exercises
|
Balance, Gaze Stabilization, Habituation, and Walking exercises
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
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
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
|
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
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
|
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
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
|
10 weeks (the outcomes will be obtained pre- and post-training)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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
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.
|
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
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.
|
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
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.
|
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
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
|
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: 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.
|
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: 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.
|
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 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.
|
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: 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.
|
10 weeks (the outcomes will be obtained pre- and post-training)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Brooke N Klatt, PhD, PT, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 10, 2019
Primary Completion (ACTUAL)
December 31, 2019
Study Completion (ACTUAL)
December 31, 2019
Study Registration Dates
First Submitted
March 21, 2019
First Submitted That Met QC Criteria
March 22, 2019
First Posted (ACTUAL)
March 25, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 24, 2020
Last Update Submitted That Met QC Criteria
March 23, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY18120038
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cognitive Impairment
-
University of California, San FranciscoNational Institute on Aging (NIA)RecruitingMild Cognitive Impairment | Cognitive Decline | Cognitive Deterioration | Cognitive Impairment, Mild | Cognitive Deficits, MildUnited States
-
Stanford UniversityRecruitingMild Cognitive Impairment | Subjective Cognitive ImpairmentUnited States
-
Fondazione Don Carlo Gnocchi OnlusUniversity of Florence; Consorzio di Bioingeneria e Informatica Medica; Gutenberg...CompletedCognitive Dysfunction | Mild Cognitive Impairment | Vascular Cognitive ImpairmentItaly
-
University of California, Los AngelesCompletedMild Cognitive Impairment (MCI) | Age-associated Cognitive ImpairmentUnited States
-
Universidad de ZaragozaNot yet recruitingMild Cognitive Impairment | Randomized Controlled Trial | Subjective Cognitive Impairment
-
BaycrestCentre for Aging and Brain Health InnovationUnknownNeurocognitive Disorders | Cognitive Dysfunction | Mental Disorder | Cognitive Impairment, Mild | Cognitive Disorder | Nonamnestic Mild Cognitive ImpairmentCanada
-
Region SkaneLund University; Berry LabCompletedMemory Impairment | Cognitive Impairment, MildSweden
-
University of GeorgiaApplied Universal Dynamics, Corp.; Van Robotics, Inc.Active, not recruitingRobot-assisted Cognitive Training for Lonely Older Adults With Mild Cognitive Impairment (MCI) (MCI)Cognitive Change | Aging | Cognitive Impairment, MildUnited States
-
University Health Network, TorontoRecruiting
-
Wake Forest University Health SciencesActive, not recruiting
Clinical Trials on Vestibular Physical Therapy
-
Johns Hopkins UniversityNational Institute on Aging (NIA)RecruitingAlzheimer Disease | Vestibular Diseases | Vestibular DisorderUnited States
-
Walsh UniversityAmerican Academy of Orthopaedic Manual Physical Therapists; Kent State University and other collaboratorsCompletedDizziness | Brain ConcussionUnited States
-
Imperial College LondonHomerton University Hospital NHS Foundation TrustWithdrawnPusher SyndromeUnited Kingdom
-
Riphah International UniversityCompletedBenign Paroxysmal Positional Vertigo (Disorder)Pakistan
-
University of Alabama at BirminghamFoundation for Physical Therapy ResearchRecruitingVestibulocochlear Nerve Diseases | Vestibular Disorder | Bilateral Vestibular LossUnited States
-
Riphah International UniversityCompletedBenign Paroxysmal Positional VertigoPakistan
-
National Taiwan University HospitalCompleted
-
Sohag UniversityRecruiting
-
Mountain Home Research & Education CorporationCongressionally Directed Medical Research ProgramsNot yet recruitingDizziness | Mild Traumatic Brain Injury
-
Oregon Health and Science UniversityUnited States Department of DefenseNot yet recruitingRehabilitation | Mild Traumatic Brain Injury, Concussion | Balance ImpairmentUnited States