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

NCT ID: NCT02142946

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Balance Control

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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RIS MS patients

Radiologically Isolated Syndrome (RIS) MS patients

No interventions assigned to this group

CIS MS patients

Clinically Isolated Syndrome (CIS) patients during a stable phase

No interventions assigned to this group

RRMS patients

Relapsing-remitting (RR) MS patients during a stable phase

No interventions assigned to this group

SPMS Patients

Secondary progressive MS patients (SPMS)

No interventions assigned to this group

PPMS Patients

Primary progressive MS patients (PPMS)

No interventions assigned to this group

Controls

Age and gender matched controls

No interventions assigned to this group

CI Patients

Cochlear Implant patients pre- and post-operatively

No interventions assigned to this group

UVL Patients

Unilateral vestibular loss patients in acute and compensated state

No interventions assigned to this group

Chronic UVL

Chronic unilateral vestibular loss patients

No interventions assigned to this group

Phobic

Phobic vertigo patients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Balance deficits due to inner ear disease or MS

Exclusion Criteria

* Inability to walk without a walking aid
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John HJ Allum, DSc

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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Lab for Exp Otoneurology, University Hospital Basel

Basel, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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John Allum, DSc

Role: CONTACT

0041-61-2652041

Facility Contacts

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John HJ Allum, DSc

Role: primary

41612652041

Other Identifiers

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2014-026

Identifier Type: -

Identifier Source: org_study_id

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