Skip to content

Dynamic Balance Training in Multiple Sclerosis

Dynamic Balance Training in Multiple Sclerosis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04719494
Enrollment
20
Registered
2021-01-22
Start date
2017-01-01
Completion date
2020-08-31
Last updated
2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

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.

Interventions

OTHERDynamic balance walking training

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.

Sponsors

Greater Milwaukee Foundation
CollaboratorUNKNOWN
Marquette University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Functional Gait AssessmentBefore 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 StabilityBefore 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 WidthBefore 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.

Secondary

MeasureTime frameDescription
Change in 10-Meter Walk TestBefore and after training (occurs within 5-week period)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.
Change in Step LengthBefore and after training (occurs within 5-week period)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.
Change in Step FrequencyBefore and after training (occurs within 5-week period)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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026