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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02142946
Other study ID # 2014-026
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2018
Est. completion date December 2025

Study information

Verified date March 2024
Source University Hospital, Basel, Switzerland
Contact John Allum, DSc
Phone 0041-61-2652041
Email john.allum@usb.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 2025
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Balance deficits due to inner ear disease or MS Exclusion Criteria: - Inability to walk without a walking aid

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Lab for Exp Otoneurology, University Hospital Basel Basel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in balance during stance and gait Measurement of trunk sway as balance measure during stance and gait trials 1 year
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