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

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ClinicalTrials.gov Identifier: NCT02142946
Recruitment Status : Recruiting
First Posted : May 20, 2014
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease
Balance Control

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: 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.
Actual Study Start Date : April 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change in balance during stance and gait [ Time Frame: 1 year ]
    Measurement of trunk sway as balance measure during stance and gait trials



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with MS or UVL
Criteria

Inclusion Criteria:

  • Balance deficits due to inner ear disease or MS

Exclusion Criteria:

  • Inability to walk without a walking aid

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142946


Contacts
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Contact: John Allum, DSc 0041-61-2652041 john.allum@usb.ch

Locations
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Switzerland
Lab for Exp Otoneurology, University Hospital Basel Recruiting
Basel, Switzerland, CH-4031
Contact: John HJ Allum, DSc    41612652041    john.allum@usb.ch   
Principal Investigator: John HJ Allum, DSc         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: John HJ Allum, DSc University Hospital, Basel, Switzerland
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02142946    
Other Study ID Numbers: 2014-026
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases