Dynamic Balance Training in Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dynamic balance walking training
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Training Group
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04719494
First Posted
September 4, 2020
Last Updated
January 20, 2021
Sponsor
Marquette University
Collaborators
Greater Milwaukee Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04719494
Brief Title
Dynamic Balance Training in Multiple Sclerosis
Official Title
Dynamic Balance Training in Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
August 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marquette University
Collaborators
Greater Milwaukee Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dynamic balance walking training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Functional Gait Assessment
Description
The functional gait assessment (FGA) is a clinically accepted tool and is used to measure postural stability before and after the proposed walking paradigm.
Time Frame
Before and after training (occurs within 5-week period)
Title
Change in Dynamic Stability
Description
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.
Time Frame
Before and after training (occurs within 5-week period)
Title
Change in Step Width
Description
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.
Time Frame
Before and after training (occurs within 5-week period)
Secondary Outcome Measure Information:
Title
Change in Step Length
Description
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.
Time Frame
Before and after training (occurs within 5-week period)
Title
Change in Step Frequency
Description
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.
Time Frame
Before and after training (occurs within 5-week period)
Title
Change in 10-Meter Walk Test
Description
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.
Time Frame
Before and after training (occurs within 5-week period)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dynamic Balance Training in Multiple Sclerosis
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