Gaze and Postural Stability in Multiple Sclerosis

NCT03521557 | Completed

• 1 other identifier: IRB_00104298
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

In order to provide information that will improve therapy, the goals of this project are to determine if persons with MS with complaints of dizziness and at risk for falls can improve their balance and vision stability as a result of a bout of specific treatment. This project seeks to do this by conducting an experiment where people with MS are randomly assigned to a group that practices activities known to help improve inner ear function or a group that practices activities known to improve endurance and strength but that should not change inner ear function. Such a comparison will allow us to gain understanding of how the inner ear system is affected in MS and how it responds to treatment.

Conditions

Multiple Sclerosis; Vertigo; Dizziness; Falls Injury

Outcome Measures

Primary Outcomes (1)

• Dizziness Handicap Inventory

  Dizziness Handicap Inventory (DHI): The DHI is a self assessment inventory designed to evaluate the self-perceived handicap effects imposed by dizziness or unsteadiness and has documented test-retest and internal consistency reliability in PwMS.\[72-76\]. The DHI consists of 25 questions subgroup into functional, emotional, and physical components. The total score ranges from 0-100, with higher scores indicating greater handicap. Collected at intervention completion, adjusting for baseline (DHI values collected at baseline assessment, prior to intervention).

  At intervention completion (6 weeks)

Secondary Outcomes (12)

• Dizziness Handicap Inventory Follow-up

  1-month follow-up post intervention (10 weeks)

• Activity Specific Balance Confidence Scale

  At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)

• Functional Gait Assessment

  At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)

• Mini-BEST test

  At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)

• Dynamic Visual Acuity

  At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)

Other Outcomes (4)

• Expanded Disability Status Scale

  Baseline

• Six minute walk test

  At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)

• Modified Fatigue Impact Scale

  At intervention completion (6 weeks) and 1-month follow-up post intervention (10 weeks)

Study Arms (2)

Gaze and Postural Stability

EXPERIMENTAL

The duration and content of the Gaze and Postural Stability (GPS) intervention is specifically designed to focus on gradually increasing difficulty of gaze and postural stability exercises. The target duration of each in clinic visit will be 90 min (15 min of gaze stability exercises, 15 min of postural stability exercises and approximately 60 min for the standard care control intervention with rest interspersed throughout the exercise session. Gaze stability exercise will consist of progressive Vestibular-occular training. Postural stability exercises will consist of progressive static and dynamic postural training.

Behavioral: Gaze and Postural Stability; Behavioral: Standard Care Control

Standard Care Control

ACTIVE COMPARATOR

The Standard Care Control intervention is specifically designed to be focused on improving overall endurance and lower extremity muscular strength. The target duration of each in clinic visit will be 90 min (30 min of aerobic exercise, 30 min of lower extremity resistance exercises, and 30 min of rest interspersed throughout the exercise session.

Behavioral: Standard Care Control

Interventions

Gaze and Postural Stability BEHAVIORAL

The duration and content of the GPS intervention is specifically designed to focus on gradually increasing difficulty of gaze and postural stability exercises.

Also known as: GPS

Gaze and Postural Stability

Standard Care Control BEHAVIORAL

The Standard Care Control intervention is specifically designed to be focused on improving overall endurance and lower extremity muscular strength.

Also known as: Standard Care Control (SCC)

Gaze and Postural Stability; Standard Care Control

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Neurologist-diagnosed, clinically definite MS
• Expanded Disability Severity Scale (EDSS) score of less than 6.0
• Current complaints of dizziness (DHI \> 0)
• At risk of falls (determined by \> 2 falls in past year or Dynamic Gait Index \<19 or Activity Specific Balance Confidence Scale \<80
• Ability to tolerate repetitive 5 min bouts of angular head motions.

You may not qualify if:

• Central or Peripheral Nervous System disorders (other than MS)
• Otologic, Cervical spine, or lower extremity injury in last 12 months
• Exercise or alcohol use in last 48 hours
• Currently taking vestibular suppressant medications
• Peripheral Vestibular Pathology (BPPV, hypofunction, Meniere's disease
• Internuclear Opthalmoplegia
• MS exacerbation within last 8 weeks
• Orthopedic, neurologic, or cognitive comorbidities that would limit participation in the study procedures

Sponsors & Collaborators

• University of Utah: lead
• National Multiple Sclerosis Society: collaborator
• Arizona State University: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (2)

• Loyd BJ, Saviers-Steiger J, Fangman A, Ballard P, Taylor C, Schubert M, Dibble L. Turning Toward Monitoring of Gaze Stability Exercises: The Utility of Wearable Sensors. J Neurol Phys Ther. 2020 Oct;44(4):261-267. doi: 10.1097/NPT.0000000000000329.

  PMID: 32815892 DERIVED

• Loyd BJ, Fangman A, Peterson DS, Gappmaier E, Schubert MC, Thackery A, Dibble L. Rehabilitation to improve gaze and postural stability in people with multiple sclerosis: study protocol for a prospective randomized clinical trial. BMC Neurol. 2019 Jun 10;19(1):119. doi: 10.1186/s12883-019-1353-z.

  PMID: 31179920 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Vertigo; Dizziness

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sensation Disorders

Study Officials

• Lee Dibble, PhD, PT

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be assessed at baseline prior to randomization. Once baseline assessments are completed, participants will be randomized to one of 2 study groups. Interventions will occur at a different site than assessments to avoid unmasking. At the post test and follow-up assessment time points, participants will be instructed not to divulge their group assignment to their assessor (the same individual that assessed them at baseline).
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 2 group x 3 time interval

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: May 11, 2018
• Study Start: May 29, 2018
• Primary Completion: June 30, 2020
• Study Completion: September 30, 2020
• Last Updated: October 6, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)