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Clinical Trials/NCT02142946
NCT02142946
Recruiting
N/A

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.

University Hospital, Basel, Switzerland1 site in 1 country300 target enrollmentApril 1, 2018
ConditionsBalance Control

Overview

Phase
N/A
Intervention
Not specified
Conditions
Balance Control
Sponsor
University Hospital, Basel, Switzerland
Enrollment
300
Locations
1
Primary Endpoint
Change in balance during stance and gait
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2018
End Date
December 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Basel, Switzerland
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Balance deficits due to inner ear disease or MS

Exclusion Criteria

  • Inability to walk without a walking aid

Outcomes

Primary Outcomes

Change in balance during stance and gait

Time Frame: 1 year

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

Study Sites (1)

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