Quantified Balance Measures During Stance and Gait: Multiple Sclerosis Patients. A Longitudinal Clinical Study (MS-Gait)

Quantified Balance Measures During Stance and Gait: Clinical Relevance for Multiple Sclerosis Patients in Comparison to Patients With Inner Ear Balance Problems. A Longitudinal Clinical Study.

The primary objective of this project is to track changes over time in balance control parameters measured during stance and gait for different groups of multiple sclerosis (MS) patients. Our primary goal is to determine whether these changes in balance control over time predict transitions in MS progression to a more disease affected state, and are different from changes over time for patients with balance deficits due to vestibular sensory disorders. A part of this goal is also to determine whether these changes in balance control are correlated with changes in patients' self-reported deficits and are similar to those changes in balance control of patients with peripheral vestibular loss. The secondary objective is to determine for multiple sclerosis (MS) patients the relationship of their balance parameters to different gait speeds, in order to advise them on, and promote via feedback, safe walking speeds. Fulfilling the first of our objectives would lead to better tracking of MS disease changes over time, earlier quantification of onset of symptoms suggesting a worsening of disease status, and, we assume, greater patient satisfaction knowing that quantification of symptoms fits subjective feelings of balance deficits during stance and gait. Achieving the second objective would lead to improved balance during gait. We aim to carry out these objectives using equipment (SwayStar) which we have proven is sensitive to MS induced balance deficits {2}, but costs far less to operate and maintain than previously used quantification tools. We aim to investigate the balance deficits during gait in different MS patient groups using a multimodal approach with a SwayStar system (analysis of balance during stance and gait in terms of trunk-pelvis movements near the centre of mass) and patient questionnaires.

Study Overview

• Status: Recruiting
• Conditions: Balance Control

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: John Allum, DSc; Phone Number: 0041-61-2652041; Email: john.allum@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, CH-4031
    • Recruiting
    • Lab for Exp Otoneurology, University Hospital Basel
    • Contact: John HJ Allum, DSc; Phone Number: 41612652041; Email: john.allum@usb.ch
    • Principal Investigator: John HJ Allum, DSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with MS or UVL

Description

Inclusion Criteria:

• Balance deficits due to inner ear disease or MS

Exclusion Criteria:

• Inability to walk without a walking aid

Study Plan

How is the study designed?

Number of groups / cohorts

10

Cohorts and Interventions

Group / Cohort
RIS MS patients; Radiologically Isolated Syndrome (RIS) MS patients
CIS MS patients; Clinically Isolated Syndrome (CIS) patients during a stable phase
RRMS patients; Relapsing-remitting (RR) MS patients during a stable phase
SPMS Patients; Secondary progressive MS patients (SPMS)
PPMS Patients; Primary progressive MS patients (PPMS)
Controls; Age and gender matched controls
CI Patients; Cochlear Implant patients pre- and post-operatively
UVL Patients; Unilateral vestibular loss patients in acute and compensated state
Chronic UVL; Chronic unilateral vestibular loss patients
Phobic; Phobic vertigo patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in balance during stance and gait	Measurement of trunk sway as balance measure during stance and gait trials	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: John HJ Allum, DSc, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 16, 2014
• First Submitted That Met QC Criteria: May 16, 2014
• First Posted (Estimated): May 20, 2014

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: 2014-026