Rhythmic Auditory Stimulation and Walking Performance in Multiple Sclerosis (MS) Patients

NCT01086371 | Withdrawn Phase 2

• 1 other identifier: RAS Gait MS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to determine if a home-based walking program that uses RAS (Rhythmic Auditory Stimulation)is a viable and effective treatment of gait instability for people with MS.We hypothesize that an RAS-based home walking program will demonstrate significant improvements over both regular exercise and no exercise. To test this hypothesis we will compare between group differences from baseline and three weeks of intervention on 3 quantitative gait measures and 1 standardized MS measurement from the following 3 groups: RAS walking, RAS no walking Other: Walking exercise The secondary goal of the study will be to determine any carry-over effects of RAS on gait parameters in ambulatory patients with MS. We hypothesize that RAS will produce sustained changes in gait pattern due to entrainment processes. To test this hypothesis, we will compare gait parameters two weeks following the cessation of the intervention with baseline and with the last week of intervention. The third goal of this study is to determine if RAS-enhanced exercise has any transfer to improve other areas such as upper extremity function and/or cognitive function. We hypothesize that those participating in an RAS-based home walking program will demonstrate improvements in other domain areas, such as cognitive and upper body functioning. To test this hypothesis we will compare results from the Multiple Sclerosis Functional Composite(MSFC) taken at baseline and again at the end of the treatment phase for all three groups.

Conditions

Gait Disturbance in Multiple Sclerosis Patients

Keywords

Multiple Sclerosis; gait

Outcome Measures

Primary Outcomes (1)

• Stride Length

  each study visit: baseline, week 3, and week 5 a total of 3 visits over a 5 week period of time

Secondary Outcomes (1)

• 25 foot walk time

  each study visit: baseline, week 3, and week 5 a total of 3 visits over a 5 week period

Study Arms (3)

RAS walking

EXPERIMENTAL

Subjects will walk while listening to music 20 minutes per day every day during the study period.

Other: Rhythmic auditory stimulation; Other: Walking exercise

RAS no walking

ACTIVE COMPARATOR

Subjects will be listening to music but not performing walking exercise, for 20 minutes per day every day during the study period.

Other: Rhythmic auditory stimulation

Walking no RAS

ACTIVE COMPARATOR

Subjects will be walking without listening to music for 20 minutes per day every day during the study period

Other: Walking exercise

Interventions

Rhythmic auditory stimulation OTHER

Recorded music with embedded beat set 10% above the subject's baseline walking cadence.

Also known as: Rythmic Auditory Stimulation, RAS, Music

RAS no walking; RAS walking

Walking exercise OTHER

Subjects will be walking daily for a total of 20 minutes (may be broken down to smaller time periods.

Also known as: Walking

RAS walking; Walking no RAS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Diagnosis of multiple sclerosis documented in medical records
• Able to walk at least 100 feet without physical assistance (use of assistive devices such as cane, crutch, or walker is allowed.

You may not qualify if:

• Treatment for an MS exacerbation in the past 30 days
• Severe co morbidity precluding participation in the study per investigator's judgment (e.g. severe cardiac or respiratory failure)
• Severe cognitive deficits precluding informed consent or preventing the subject from following study procedures

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Walking

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Francois A Bethoux, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2010
• First Posted: March 15, 2010
• Study Start: January 1, 2012
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: June 27, 2022

Record last verified: 2022-06

Locations

US (1)