Rehabilitation to improve gaze and postural stability in people with multiple sclerosis: Study protocol for a prospective randomized clinical trial

Brian J. Loyd, Annie Fangman, Daniel Peterson, Eduard Gappmaier, Michael C. Schubert, Anne Thackery, Lee Dibble

Research output: Contribution to journalArticle

Abstract

Background: The use of vestibular rehabilitation principles in the management of gaze and postural stability impairments in people with multiple sclerosis (PwMS) has shown promise in pilot work completed in our lab and in a recently published randomized clinical trial (RCT). However, further work is needed to fully quantify the gaze and postural impairments present in people with multiple sclerosis and how they respond to rehabilitation. Methods/design: The study is a single blind RCT designed to examine the benefit of a gaze and postural stability (GPS) intervention program compared to a standard of care (SOC) rehabilitation program in dizzy and balance impaired PwMS. Outcomes will be collected across the domains of body structure and function, activity, and participation as classified by the World Health Organization International Classification of Functioning, Disability, and Health (ICF). Our primary outcomes are the Dizziness Handicap Inventory (DHI) and the Functional Gait Assessment (FGA). Secondary outcomes include other measures of gaze and postural stability, fatigue, and functional mobility. Participants who are interested and eligible for enrollment will be consented prior to completing a baseline assessment. Following the baseline assessment each participant will be randomized to either the GPS or SOC intervention group and will complete a 6 week treatment period. During the treatment period, both groups will participate in guided exercise 3x/week. Following the treatment period participants will be asked to return for a post-treatment evaluation and again for a follow-up assessment 1 month later. We anticipate enrolling 50 participants. Discussion: This study will be an innovative RCT that will utilize gaze and postural stability metrics to assess the efficacy of vestibular rehabilitation in PwMS. It will build on previous work by examining measures across the ICF and improve the current evidence base for treating PwMS. Trial registration: ClinicalTrials.gov, May 29th 2018, NCT03521557.

Original languageEnglish (US)
Article number119
JournalBMC Neurology
Volume19
Issue number1
DOIs
StatePublished - Jun 10 2019

Fingerprint

Multiple Sclerosis
Rehabilitation
Randomized Controlled Trials
Standard of Care
International Classification of Functioning, Disability and Health
Dizziness
Therapeutics
Gait
Fatigue
Equipment and Supplies

Keywords

  • Gaze stability
  • Multiple sclerosis
  • Postural stability
  • Randomized clinical trial
  • Vestibular rehabilitation

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Rehabilitation to improve gaze and postural stability in people with multiple sclerosis : Study protocol for a prospective randomized clinical trial. / Loyd, Brian J.; Fangman, Annie; Peterson, Daniel; Gappmaier, Eduard; Schubert, Michael C.; Thackery, Anne; Dibble, Lee.

In: BMC Neurology, Vol. 19, No. 1, 119, 10.06.2019.

Research output: Contribution to journalArticle

Loyd, Brian J. ; Fangman, Annie ; Peterson, Daniel ; Gappmaier, Eduard ; Schubert, Michael C. ; Thackery, Anne ; Dibble, Lee. / Rehabilitation to improve gaze and postural stability in people with multiple sclerosis : Study protocol for a prospective randomized clinical trial. In: BMC Neurology. 2019 ; Vol. 19, No. 1.
@article{5034e1d881524cf0a1df90c169411b88,
title = "Rehabilitation to improve gaze and postural stability in people with multiple sclerosis: Study protocol for a prospective randomized clinical trial",
abstract = "Background: The use of vestibular rehabilitation principles in the management of gaze and postural stability impairments in people with multiple sclerosis (PwMS) has shown promise in pilot work completed in our lab and in a recently published randomized clinical trial (RCT). However, further work is needed to fully quantify the gaze and postural impairments present in people with multiple sclerosis and how they respond to rehabilitation. Methods/design: The study is a single blind RCT designed to examine the benefit of a gaze and postural stability (GPS) intervention program compared to a standard of care (SOC) rehabilitation program in dizzy and balance impaired PwMS. Outcomes will be collected across the domains of body structure and function, activity, and participation as classified by the World Health Organization International Classification of Functioning, Disability, and Health (ICF). Our primary outcomes are the Dizziness Handicap Inventory (DHI) and the Functional Gait Assessment (FGA). Secondary outcomes include other measures of gaze and postural stability, fatigue, and functional mobility. Participants who are interested and eligible for enrollment will be consented prior to completing a baseline assessment. Following the baseline assessment each participant will be randomized to either the GPS or SOC intervention group and will complete a 6 week treatment period. During the treatment period, both groups will participate in guided exercise 3x/week. Following the treatment period participants will be asked to return for a post-treatment evaluation and again for a follow-up assessment 1 month later. We anticipate enrolling 50 participants. Discussion: This study will be an innovative RCT that will utilize gaze and postural stability metrics to assess the efficacy of vestibular rehabilitation in PwMS. It will build on previous work by examining measures across the ICF and improve the current evidence base for treating PwMS. Trial registration: ClinicalTrials.gov, May 29th 2018, NCT03521557.",
keywords = "Gaze stability, Multiple sclerosis, Postural stability, Randomized clinical trial, Vestibular rehabilitation",
author = "Loyd, {Brian J.} and Annie Fangman and Daniel Peterson and Eduard Gappmaier and Schubert, {Michael C.} and Anne Thackery and Lee Dibble",
year = "2019",
month = "6",
day = "10",
doi = "10.1186/s12883-019-1353-z",
language = "English (US)",
volume = "19",
journal = "BMC Neurology",
issn = "1471-2377",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - Rehabilitation to improve gaze and postural stability in people with multiple sclerosis

T2 - Study protocol for a prospective randomized clinical trial

AU - Loyd, Brian J.

AU - Fangman, Annie

AU - Peterson, Daniel

AU - Gappmaier, Eduard

AU - Schubert, Michael C.

AU - Thackery, Anne

AU - Dibble, Lee

PY - 2019/6/10

Y1 - 2019/6/10

N2 - Background: The use of vestibular rehabilitation principles in the management of gaze and postural stability impairments in people with multiple sclerosis (PwMS) has shown promise in pilot work completed in our lab and in a recently published randomized clinical trial (RCT). However, further work is needed to fully quantify the gaze and postural impairments present in people with multiple sclerosis and how they respond to rehabilitation. Methods/design: The study is a single blind RCT designed to examine the benefit of a gaze and postural stability (GPS) intervention program compared to a standard of care (SOC) rehabilitation program in dizzy and balance impaired PwMS. Outcomes will be collected across the domains of body structure and function, activity, and participation as classified by the World Health Organization International Classification of Functioning, Disability, and Health (ICF). Our primary outcomes are the Dizziness Handicap Inventory (DHI) and the Functional Gait Assessment (FGA). Secondary outcomes include other measures of gaze and postural stability, fatigue, and functional mobility. Participants who are interested and eligible for enrollment will be consented prior to completing a baseline assessment. Following the baseline assessment each participant will be randomized to either the GPS or SOC intervention group and will complete a 6 week treatment period. During the treatment period, both groups will participate in guided exercise 3x/week. Following the treatment period participants will be asked to return for a post-treatment evaluation and again for a follow-up assessment 1 month later. We anticipate enrolling 50 participants. Discussion: This study will be an innovative RCT that will utilize gaze and postural stability metrics to assess the efficacy of vestibular rehabilitation in PwMS. It will build on previous work by examining measures across the ICF and improve the current evidence base for treating PwMS. Trial registration: ClinicalTrials.gov, May 29th 2018, NCT03521557.

AB - Background: The use of vestibular rehabilitation principles in the management of gaze and postural stability impairments in people with multiple sclerosis (PwMS) has shown promise in pilot work completed in our lab and in a recently published randomized clinical trial (RCT). However, further work is needed to fully quantify the gaze and postural impairments present in people with multiple sclerosis and how they respond to rehabilitation. Methods/design: The study is a single blind RCT designed to examine the benefit of a gaze and postural stability (GPS) intervention program compared to a standard of care (SOC) rehabilitation program in dizzy and balance impaired PwMS. Outcomes will be collected across the domains of body structure and function, activity, and participation as classified by the World Health Organization International Classification of Functioning, Disability, and Health (ICF). Our primary outcomes are the Dizziness Handicap Inventory (DHI) and the Functional Gait Assessment (FGA). Secondary outcomes include other measures of gaze and postural stability, fatigue, and functional mobility. Participants who are interested and eligible for enrollment will be consented prior to completing a baseline assessment. Following the baseline assessment each participant will be randomized to either the GPS or SOC intervention group and will complete a 6 week treatment period. During the treatment period, both groups will participate in guided exercise 3x/week. Following the treatment period participants will be asked to return for a post-treatment evaluation and again for a follow-up assessment 1 month later. We anticipate enrolling 50 participants. Discussion: This study will be an innovative RCT that will utilize gaze and postural stability metrics to assess the efficacy of vestibular rehabilitation in PwMS. It will build on previous work by examining measures across the ICF and improve the current evidence base for treating PwMS. Trial registration: ClinicalTrials.gov, May 29th 2018, NCT03521557.

KW - Gaze stability

KW - Multiple sclerosis

KW - Postural stability

KW - Randomized clinical trial

KW - Vestibular rehabilitation

UR - http://www.scopus.com/inward/record.url?scp=85067109174&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85067109174&partnerID=8YFLogxK

U2 - 10.1186/s12883-019-1353-z

DO - 10.1186/s12883-019-1353-z

M3 - Article

C2 - 31179920

AN - SCOPUS:85067109174

VL - 19

JO - BMC Neurology

JF - BMC Neurology

SN - 1471-2377

IS - 1

M1 - 119

ER -