Clinical trial NCT04719494: Dynamic Balance Training in Multiple Sclerosis
Official title: Dynamic Balance Training in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Marquette University
Sponsor class: OTHER
Collaborators: name: Greater Milwaukee Foundation
First posted: 2021-01-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Functional Gait Assessment
timeFrame: Before and after training (occurs within 5-week period)
measure: Change in Dynamic Stability
timeFrame: Before and after training (occurs within 5-week period)
measure: Change in Step Width
timeFrame: Before and after training (occurs within 5-week period)
Secondary outcomes:
measure: Change in Step Length
timeFrame: Before and after training (occurs within 5-week period)
measure: Change in Step Frequency
timeFrame: Before and after training (occurs within 5-week period)
measure: Change in 10-Meter Walk Test
timeFrame: Before and after training (occurs within 5-week period)
Other outcomes:
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Study officials:
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