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

NCT02142946 | Recruiting

• 1 other identifier: 2014-026
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Balance Control

Outcome Measures

Primary Outcomes (1)

• Change in balance during stance and gait

  Measurement of trunk sway as balance measure during stance and gait trials

  1 year

Study Arms (10)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with MS or UVL

You may qualify if:

• Balance deficits due to inner ear disease or MS

You may not qualify if:

• Inability to walk without a walking aid

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Lab for Exp Otoneurology, University Hospital Basel

Basel, CH-4031, Switzerland

RECRUITING

Study Officials

• John HJ Allum, DSc

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Allum, DSc

CONTACT

0041-61-2652041; john.allum@usb.ch

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: May 20, 2014
• Study Start: April 1, 2018
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

CH (1)