Multiple SclerosisNCT04719494
Dynamic Balance Training in Multiple Sclerosis
A study testing Dynamic balance walking training in people with Multiple Sclerosis, run by Marquette University.
Trial summary
This study will test a new technique for improving balance while walking in people with multiple sclerosis (MS). The technique focuses on having people with MS safely practice walking on simulated, uneven terrain that challenges balance and more accurately mimics walking in the community. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Dynamic balance walking training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants have been clinically diagnosed with multiple sclerosis
- Must be capable of walking 10 meters independently with no physical assistance
- Must be able to ascend/descend a small staircase (5 steps)
- Medically stable
- Able to give informed consent
Who cannot join
- they suffer from cognitive deficits that prevent them from following 1 step commands
- unable to give informed consent
- if they suffer from significant cardiovascular problems, respiratory failure, major orthopedic problems, or other medical conditions that affect balance (e.g. diabetic neuropathy, myopathy, or vertigo)
- Significant medical comorbidity or concurrent illness limiting their capacity to conform to study requirements
About this study
This study will test a new technique for improving balance while walking in people with multiple sclerosis (MS). The technique focuses on having people with MS safely practice walking on simulated, uneven terrain that challenges balance and more accurately mimics walking in the community. The goal is to improve balance while walking in order to improve mobility and decrease the risk of falls. Recently, we developed a state-of-the-art treadmill system that allows us to create a challenging walking environment by placing a treadmill onto a motion base. We are able to simulate uneven terrain through movements of the walking surface while maintaining a safe walking environment. We will use this system to conduct tests of balance while walking and to train people to walk on uneven surfaces. Our objective is to evaluate the use of uneven terrain for training gait and balance in people with MS. Participants will undergo a four-week training protocol designed to disrupt and challenge balance while walking. We anticipate that training on uneven terrain will enhance gait stability, improve overall walking function and balance and increase balance confidence compared to training on a stable surface.
- Conditions
- Multiple Sclerosis
- Being tested
- Dynamic balance walking training
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic balance walking trainingOther
Participants in the training group will walk on an elevated treadmill that will move side-to-side in a pseudorandom manner, thereby increasing the difficulty to their balance. Participants are asked to walk independently for 30-minutes per session, for 12 days over 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | During the 12-training day sessions, subjects will walk on the treadmill for a total of 30 minutes. Participants will walk at a comfortable pace while we perform controlled movements to the treadmill system. Subjects will be fitted with a fall-arrest harness and assisted onto the treadmill system. In the dynamic balance training group, we will move the motion base as participants walk in order to challenge their balance. Receives: Other: Dynamic balance walking training |
| Control Group | No intervention | Subjects who are in the control group will also walk on the treadmill, but the motion base will remain stationary. They will complete 12-training day sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Gait Assessment
The functional gait assessment (FGA) is a clinically accepted tool and is used to measure postural stability before and after the proposed walking paradigm.
Measured: Before and after training (occurs within 5-week period)
Change in Dynamic Stability
Dynamic Stability is assessed using the margin of stability (MoS). The MoS is defined as the center of mass position and velocity relative to the edge of the person's base of support. If the center of mass falls outside the base of support, the individual may require corrective action to restore balance and/or be at higher risk for loss of balance. For this study, we measured the center of mass motion and foot placement (i.e., base of support) in the medio-lateral direction to calculate each person's MoS before and after the 4-week walking sessions.
Measured: Before and after training (occurs within 5-week period)
Change in Step Width
Step width was measured for all individuals as the distance (centimeters) between the left and right ankle during double-limb support of each gait cycle. We measured step width before and after the 4-week walking sessions.
Measured: Before and after training (occurs within 5-week period)
Secondary outcomes (3)
Change in Step Length
Step Length was measured for all individuals as the distance (centimeters) between the left big toe and right big toe at the time the heel of the leading foot made contact with the treadmill belt at each gait cycle. We measured step length before and after the 4-week walking sessions.
Measured: Before and after training (occurs within 5-week period)
Change in Step Frequency
Step Frequency was measured for all individuals as the number of steps occurring within a 60-second time window (units of Hz). We measured step frequency before and after the 4-week walking sessions.
Measured: Before and after training (occurs within 5-week period)
Change in 10-Meter Walk Test
The 10-Meter Walk Test was administered at self-selected overground walking speeds for each individual. We assess walking speed with this tool before and after the proposed walking paradigm.
Measured: Before and after training (occurs within 5-week period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Jan 2017
- Primary completion31 May 2019
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marquette University
- Sponsor type
- University, hospital or other
- Collaborators
- Greater Milwaukee Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719494
- Sponsor's protocol ID
- 74915
- Status last verified
- Jan 2021
- First submitted
- 4 Sep 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Balance Training in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04719494
- Acronym / sponsor ID
- 74915
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Marquette UniversityUniversity, hospital or other
- Collaborators
- Greater Milwaukee Foundation
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 22 Jan 2021 (actual)
- 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.
This study will test a new technique for improving balance while walking in people with multiple sclerosis (MS). The technique focuses on having people with MS safely practice walking on simulated, uneven terrain that challenges balance and more accurately mimics walking in the community. The goal is to improve balance while walking in order to improve mobility and decrease the risk of falls. Recently, we developed a state-of-the-art treadmill system that allows us to create a challenging walking environment by placing a treadmill onto a motion base. We are able to simulate uneven terrain through movements of the walking surface while maintaining a safe walking environment. We will use this system to conduct tests of balance while walking and to train people to walk on uneven surfaces. Our objective is to evaluate the use of uneven terrain for training gait and balance in people with MS. Participants will undergo a four-week training protocol designed to disrupt and challenge balance while walking. We anticipate that training on uneven terrain will enhance gait stability, improve overall walking function and balance and increase balance confidence compared to training on a stable surface.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Other: Dynamic balance walking trainingDuring the 12-training day sessions, subjects will walk on the treadmill for a total of 30 minutes. Participants will walk at a comfortable pace while we perform controlled movements to the treadmill system. Subjects will be fitted with a fall-arrest harness and assisted onto the treadmill system. In the dynamic balance training group, we will move the motion base as participants walk in order to challenge their balance. |
| Control Group | No intervention | –Subjects who are in the control group will also walk on the treadmill, but the motion base will remain stationary. They will complete 12-training day sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants have been clinically diagnosed with multiple sclerosis
- Must be capable of walking 10 meters independently with no physical assistance
- Must be able to ascend/descend a small staircase (5 steps)
- Medically stable
- Able to give informed consent
Key exclusion criteria (4 listed)
- they suffer from cognitive deficits that prevent them from following 1 step commands
- unable to give informed consent
- if they suffer from significant cardiovascular problems, respiratory failure, major orthopedic problems, or other medical conditions that affect balance (e.g. diabetic neuropathy, myopathy, or vertigo)
- Significant medical comorbidity or concurrent illness limiting their capacity to conform to study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic balance walking trainingParticipants in the training group will walk on an elevated treadmill that will move side-to-side in a pseudorandom manner, thereby increasing the difficulty to their balance. Participants are asked to walk independently for 30-minutes per session, for 12 days over 4 weeks. | Other | Training Group |
Primary outcome
Change in Functional Gait Assessment
Time frame: Before and after training (occurs within 5-week period)
The functional gait assessment (FGA) is a clinically accepted tool and is used to measure postural stability before and after the proposed walking paradigm.
Change in Dynamic Stability
Time frame: Before and after training (occurs within 5-week period)
Dynamic Stability is assessed using the margin of stability (MoS). The MoS is defined as the center of mass position and velocity relative to the edge of the person's base of support. If the center of mass falls outside the base of support, the individual may require corrective action to restore balance and/or be at higher risk for loss of balance. For this study, we measured the center of mass motion and foot placement (i.e., base of support) in the medio-lateral direction to calculate each person's MoS before and after the 4-week walking sessions.
Change in Step Width
Time frame: Before and after training (occurs within 5-week period)
Step width was measured for all individuals as the distance (centimeters) between the left and right ankle during double-limb support of each gait cycle. We measured step width before and after the 4-week walking sessions.
3 secondary outcomes
Change in Step Length
Time frame: Before and after training (occurs within 5-week period)
Change in Step Frequency
Time frame: Before and after training (occurs within 5-week period)
Change in 10-Meter Walk Test
Time frame: Before and after training (occurs within 5-week period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic balance walking training in people with Multiple Sclerosis, run by Marquette University.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Gait Assessment (time frame: Before and after training (occurs within 5-week period)). The study lists 3 primary outcomes in all. 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 22 Jan 2021.