Dynamic Balance Training in Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Dynamic balance walking training

• Registration Number: NCT04719494
• Lead Sponsor: Marquette University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2019-05-31
• Study Completion: 2020-08-31
• Study First Submitted: 2020-09-04
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-20
• Last Update Submitted: 2021-01-20
• Study First Posted: 2021-01-22
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Training Group	Dynamic balance walking training	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.

Primary Outcome Measures

Name	Time	Method
Change in Step Width	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.
Change in Functional Gait Assessment	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	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.

Secondary Outcome Measures

Name	Time	Method
Change in Step Length	Before 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 10-Meter Walk Test	Before 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 Frequency	Before 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.