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NCT Number: NCT02065284

Effects of a Home Based Walking Program Using Rhythmic Auditory Stimulation in Patients With Multiple Sclerosis

Rhythmic Auditory Stimulation (RAS) is a music therapy technique that provides rhythmic auditory cues (like a beat) to help improve patients' movements, especially when walking.

The purpose of this study is to compare the effect on walking performance of a home based walking program (HBWP) with Rhythmic Auditory Stimulation (RAS), to that of a HBWP without RAS, or to RAS without walking exercise.

A second part of this study will assess the effects of Rhythmic Auditory Stimulation (RAS) on brain activity in patients with Multiple Sclerosis while performing mental imagery of walking.

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Key information

Conditions

Multiple Sclerosis Ambulation Difficulty Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Mobility Limitation Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Neurological Institute Mellen Center

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18 years or older
  • diagnosis of MS per Mc Donald criteria
  • Ambulation Index score from 2 to 6 inclusive (clinically observable gait disturbance, whether the subject walks with no, unilateral, or bilateral support)
  • spastic paresis is the main neurologic impairment causing the gait disturbance, per investigator's judgment.

Exclusion criteria

  • neurologic impairments other than spastic paresis (e.g. cerebellar ataxia or sensory ataxia), or non-neurologic impairments (e.g. musculoskeletal problems) play a major role in the subject's gait disturbance, per investigator's judgment;
  • 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 safely
  • contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc.
  • pregnancy.

Treatment and study plan

Rhythmic auditory stimulation (RAS)

Other

Rhythmic Auditory Stimulation (RAS) is a music therapy technique that provides rhythmic auditory cues (like a beat) to help improve patients' movements, especially when walking.

Other names: RAS

Primary outcomes

  1. Improved gait pattern on gait analysis

    Time frame: 8 weeks

    To compare the effect on gait pattern of a walking program with Rhythmic Auditory Stimulation, to that of a walking program without Rhythmic Auditory Stimulation, or Rhythmic Auditory Stimulation without walking exercise.

Secondary outcomes

  1. Improved walk time on the timed 25 foot walk test

    Time frame: 8 weeks

    To compare the effect on walking performance of a walking program with Rhythmic Auditory Stimulation, to that of a walking program without Rhythmic Auditory Stimulation, or Rhythmic Auditory Stimulation without walking exercise.

  2. Improved distance on the 2 minute walk test

    Time frame: 8 weeks

    To compare the effect on walking performance of a walking program with Rhythmic Auditory Stimulation, to that of a walking program without Rhythmic Auditory Stimulation, or Rhythmic Auditory Stimulation without walking exercise.

Other outcomes

  1. To assess changes in cortical activation induced by Rhythmic Auditory Stimulation in Multiple Sclerosis patients performing mental imagery of walking.

    Time frame: 8 weeks

    Collect functional MRI images while performing guided imagery.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • The Kelvin and Eleanor Smith Foundation

Registry information

Official study title

Effects of a Home Based Walking Program Using Rhythmic Auditory Stimulation on Walking and Cortical Activation in Patients With Multiple Sclerosis.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 19, 2014
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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