Dynamic Balance Training in Multiple Sclerosis

NCT ID: NCT04719494

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2020-08-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Training Group

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.

Group Type: EXPERIMENTAL

Dynamic balance walking training

Intervention Type: OTHER

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.

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dynamic 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Greater Milwaukee Foundation

UNKNOWN

Sponsor Role: collaborator

Marquette University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

74915

Identifier Type: -

Identifier Source: org_study_id