Longitudinal Recovery of Laboratory, Clinical, and Community-Based Measures of Head and Trunk Control in People With Acquired Vestibulopathy

NCT04594057 | Terminated

• 2 other identifiers: IRB_00125069NIFTI
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to examine the true impact inner-ear dysfunction has on patient head movement kinematics, activity levels, and participation, and (2) to explore the efficacy of rehabilitation on laboratory, clinical, and community-based outcomes in people following surgical removal of a schwannoma from the inner-ear nerve.

Conditions

Vestibular Schwannoma; Vestibular Disorder

Outcome Measures

Primary Outcomes (4)

• Change in Dizziness Handicap Inventory (DHI)

  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. 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. Change from baseline to 6 weeks post surgery.

  Change baseline to 6 weeks

• Change in miniBEST test

  the 14-item Mini-BESTest which includes four sections (anticipatory postural adjustments, reactive postural responses, sensory orientation, and stability in gait) relevant to postural control and stability in MS. The maximum possible score is 28 with higher scores indicating better balance. Tasks within the Mini-BEST test require head and/ or body motion, which will be assessed using body-worn 3D accelerometers. The Change from the baseline score to the 6 weeks post surgery score.

  Change from baseline to 6 weeks

• Change in Community-simulated Ambulatory Task (CAT)

  Community-simulated walking task consisting of turns, stairs, and inside/outside ambulation requiring specific use of head and trunk turns. Change from baseline to 6 weeks post surgery.

  Change from Baseline to 6 weeks

• Change in Passive Angular Vestibular Reflex Testing

  The angular vestibular ocular reflex (aVOR) gain will be calculated as the ratio of the de-saccaded eye velocity Area Under the Curve (AUC) over the head velocity AUC between the onset of the head impulse to the moment when head velocity returns to zero. Change from baseline to 6 weeks post surgery in aVOR gain.

  Change from Baseline to 6 weeks

Secondary Outcomes (9)

• Activities Balance Confidence Scale (ABC)

  Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.

• Life Space Assessment

  Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.

• Dynamic Visual Acuity

  Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.

• Compensatory Saccade Frequency

  Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.

• Daily Step Activity

  Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.

Other Outcomes (3)

• Two-Minute Walk (2MWT)

  Baseline, 10 days post surgery, 6 weeks, and 12 weeks post surgery.

• Visual Analog Scale of Dizziness

  Baseline, 10 days post surgery, 3 weeks, 6 weeks, 9 weeks, and 12 weeks post surgery.

• Visual Analog Scale of Unsteadiness

  Baseline, 10 days post surgery, 3 weeks, 6 weeks, 9 weeks, and 12 weeks post surgery.

Study Arms (2)

Early Start

ACTIVE COMPARATOR

Begin 6 weeks of gaze and postural stability training 10-14 days following surgery.

Behavioral: Gaze and Postural Retraining Exercise

Delayed Start

EXPERIMENTAL

Begin 6 weeks of gaze and postural stability training 6 weeks following surgery.

Behavioral: Gaze and Postural Retraining Exercise

Interventions

Gaze and Postural Retraining Exercise BEHAVIORAL

Gaze and Postural Stability 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.

Delayed Start; Early Start

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Reports of dizziness as indicated by Dizziness handicap inventory score \>0
• Undergoing a vestibular schwannoma resection surgery and/or vestibular hypofunction diagnosed using bedside examination
• Able to perform community ambulation

You may not qualify if:

• Presence of cardiovascular, orthopedic, or other neurologic diagnosis that limits ability to complete study testing, or causes other forms of dizziness.
• Blindness
• Peripheral neuropathy

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Neuroma, Acoustic; Vestibular Diseases

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Labyrinth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: October 20, 2020
• Study Start: December 10, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 19, 2025

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)