Vestibular DiseasesVPT in ADNCT03887923
Vestibular Physical Therapy for People With Alzheimer Disease
A study testing Vestibular Physical Therapy in people with Vestibular Diseases and Alzheimer Disease, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Vestibular Diseases, Alzheimer Disease, Cognitive Impairment
- What is being tested?
- Vestibular Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mild-AD diagnosis
- complaints or observation of gat disturbance
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Alzheimer Disease Research Center
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Conditions
- Vestibular Diseases, Alzheimer Disease, Cognitive Impairment
- Being tested
- Vestibular Physical Therapy
- Medical subject headings
- Vestibular Diseases, Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Physical TherapyBehavioural
Also called modified-Vestibular Physical Therapy
Balance, Gaze Stabilization, Habituation, and Walking exercises
| Study group | Role | What they receive |
|---|---|---|
| Vestibular Physical Therapy | Experimental | Balance, Gaze Stabilization, Habituation, and Walking exercises Receives: Behavioral: Vestibular Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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)
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Digit Span Forward \& Backward: assesses memory by recording how many digits the participant can repeat back in the correct order immediately after presentation
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Benton Visual Retention Test: assesses visual perception and visual memory by asking participants to reproduce 10 different individual designs after a 10-second exposure.
Measured: 10 weeks (the outcomes will be obtained pre- and post-training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start10 May 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DiseasesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, Brooke Klatt, University of Pittsburgh
- Investigators
- Brooke N Klatt, PhD, PT, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887923
- Sponsor's protocol ID
- STUDY18120038
- Acronym
- VPT in AD
- Status last verified
- Mar 2020
- First submitted
- 21 Mar 2019
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Physical Therapy for People With Alzheimer Disease
- ClinicalTrials.gov ID
- NCT03887923
- Acronym / sponsor ID
- VPT in AD / STUDY18120038
- Conditions
- Vestibular Diseases, Alzheimer Disease, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- 10 May 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vestibular Physical Therapy | Experimental | Behavioral: Vestibular Physical TherapyBalance, Gaze Stabilization, Habituation, and Walking exercises |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- mild-AD diagnosis
- complaints or observation of gat disturbance
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular Physical TherapyAlso: modified-Vestibular Physical TherapyBalance, Gaze Stabilization, Habituation, and Walking exercises | Behavioural | Vestibular Physical Therapy |
Primary outcome
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).
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
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
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
9 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brooke N Klatt, PhD, PT principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Physical Therapy in people with Vestibular Diseases and Alzheimer Disease, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of Vestibular Physical Therapy in people with Alzheimer Disease: number of times modifications are needed to be made (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.