NCT03887923

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 10, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

8 months

First QC Date

March 21, 2019

Last Update Submit

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

EXPERIMENTAL

Balance, Gaze Stabilization, Habituation, and Walking exercises

Behavioral: Vestibular Physical Therapy

Interventions

Balance, Gaze Stabilization, Habituation, and Walking exercises

Also known as: modified-Vestibular Physical Therapy
Vestibular Physical Therapy

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

University of Pittsburgh Alzheimer Disease Research Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Vestibular DiseasesAlzheimer DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Brooke N Klatt, PhD, PT

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

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

Locations