Balance ControlMS-GaitNCT02142946
Quantified Balance Measures During Stance and Gait: Multiple Sclerosis Patients. A Longitudinal Clinical Study
An observational study of Balance Control, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Balance Control
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2018to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with MS or UVL
Who may be able to join
- Balance deficits due to inner ear disease or MS
Who cannot join
- Inability to walk without a walking aid
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Lab for Exp Otoneurology, University Hospital Basel
Basel, CH-4031
John HJ Allum, DSc, 41612652041, john.allum@usb.ch
John HJ Allum, DSc
About this study
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.
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in balance during stance and gait
Measurement of trunk sway as balance measure during stance and gait trials
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study start1 Apr 2018
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance ControlStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John HJ Allum, DSc, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142946
- Sponsor's protocol ID
- 2014-026
- Acronym
- MS-Gait
- Status last verified
- Apr 2025
- First submitted
- 16 May 2014
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02142946
- Acronym / sponsor ID
- MS-Gait / 2014-026
- Conditions
- Balance Control
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with MS or UVL
Key inclusion criteria (1 listed)
- Balance deficits due to inner ear disease or MS
Key exclusion criteria (1 listed)
- Inability to walk without a walking aid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in balance during stance and gait
Time frame: 1 year
Measurement of trunk sway as balance measure during stance and gait trials
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John HJ Allum, DSc principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Balance Control, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Allum, DSc (0041-61-2652041, john.allum@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in balance during stance and gait (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.