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Rhythmic Auditory Stimulation & Gait Training

Primary Purpose

Multiple Sclerosis, Gait Disorders, Neurologic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rhythmic auditory stimulation
Gait Training
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis focused on measuring Gait analysis, Music therapy, Multiple sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of MS based on 2017 revised McDonald criteria (relapsing or progressive course)
  • Performs the T25FW in 8 to 30 seconds (cane(s), walking stick(s), crutch(es), or wheeled walker allowed)

Exclusion Criteria:

  • Physical therapy in the past 3 months or immediate need for PT due to safety concerns (e.g. falls)
  • Requires at least one seated rest during the 6 MW test
  • Treatment with high-dose corticosteroids in the past 2 months or planned during the study period
  • Lower extremity botulinum toxin (BT) injections for spasticity in the past 3 months, or planned during the study period
  • Initiation of an oral symptomatic therapy which could affect walking in the past 4 weeks (particularly dalfampridine and medications for spasticity)
  • Initiation of a new disease-modifying therapy for MS in the past 3 months
  • Comorbidity compromising safe participation or affecting walking (e.g. uncontrolled cardiac or respiratory illness, musculoskeletal disorder)
  • Severe hearing impairment with or without the use of hearing aids, such that the participant cannot hear the rhythmic music stimulus consistently.

Inability to walk safely to the rhythmic music stimulus during the baseline visit.

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Gait Training (GT) with Rhythmic Auditory Stimulation (RAS)

Gait training (GT) without Rhythmic Auditory Stimulation (RAS)

Arm Description

Participants in this arm will complete 16 supervised gait training sessions consisting of continuous overground walking on a track for 30 minutes,with RAS

Participants in this arm will complete 16 supervised gait training sessions consisting of continuous overground walking on a track for 30 minutes without RAS

Outcomes

Primary Outcome Measures

Number of patients with adverse events
Adverse events will be collected throughout the study period to assess treatment safety.
Percentage of training sessions missed.
Training session attendance will be tracked as an indicator of feasibility throughout the treatment period.

Secondary Outcome Measures

Timed 25 Foot Walk
Participants are instructed to walk as fast as possible but safely on a 25-foot straight course.
6-Minute Walk
Participants are instructed to walk for 6 minutes.
Spatiotemporal gait parameters
Gait parameters at self-selected pace will be collected on an electronic walkway.
MS Walking Scale - 12
The MSWS-12 consists of 12 items inquiring about the impact of MS on various aspects of walking. Score range is from 0 to 100, with higher scores indicating a worse outcome.

Full Information

First Posted
March 11, 2020
Last Updated
February 7, 2023
Sponsor
The Cleveland Clinic
Collaborators
Consortium of Multiple Sclerosis Centers, MedRhythms, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04314076
Brief Title
Rhythmic Auditory Stimulation & Gait Training
Official Title
A Pilot Single-blind Randomized Controlled Trial to Evaluate the Safety and Feasibility of Rhythmic Auditory Stimulation for Gait Training in Persons With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 8, 2020 (Actual)
Primary Completion Date
November 7, 2022 (Actual)
Study Completion Date
November 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
Consortium of Multiple Sclerosis Centers, MedRhythms, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will enroll patients with Multiple Sclerosis and some difficulty with walking. The purpose of this study is to use Rhythmic Auditory Stimulation (RAS) a music therapy technique that provides rhythmic auditory cues (like a beat) to help improve a patient's movements, especially when walking. Participants will be asked to participate in a walking program (WP) with Rhythmic Auditory Stimulation (RAS), or a WP without RAS.
Detailed Description
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 RAS can be delivered at a fixed tempo or interactive tempo. The device used in this study will deliver an interactive tempo. The equipment will include a mobile device app and sensors that are attached to the participant's shoes. Headphones and smartphones will be required to use the device and will be provided to the study team and kept at the center for this study. The device is designed to use audio cues to facilitate improvements in the participant's walking speed while listening to music. The overall purpose of this study is to assess the safety and acceptability of interactive RAS music combined with gait training in individuals with MS and walking impairment, and to gather preliminary efficacy data for future studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Gait Disorders, Neurologic
Keywords
Gait analysis, Music therapy, Multiple sclerosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a single blind parallel-group pilot randomized controlled trial comparing rhythmic auditory stimulation (RAS) with gait training to gait training without RAS.
Masking
Outcomes Assessor
Masking Description
A blinded examiner will be used to perform the gait analysis, 6 minute walk , and timed 25 foot walk
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gait Training (GT) with Rhythmic Auditory Stimulation (RAS)
Arm Type
Active Comparator
Arm Description
Participants in this arm will complete 16 supervised gait training sessions consisting of continuous overground walking on a track for 30 minutes,with RAS
Arm Title
Gait training (GT) without Rhythmic Auditory Stimulation (RAS)
Arm Type
Other
Arm Description
Participants in this arm will complete 16 supervised gait training sessions consisting of continuous overground walking on a track for 30 minutes without RAS
Intervention Type
Other
Intervention Name(s)
Rhythmic auditory stimulation
Other Intervention Name(s)
RAS
Intervention Description
RAS, a Neurologic Music Therapy technique developed to utilize rhythm and timing cues to assist in improving the basic, intrinsic rhythmic movements of gait.
Intervention Type
Other
Intervention Name(s)
Gait Training
Other Intervention Name(s)
GT
Intervention Description
Continuous overground walking on a track for 30 minutes. Gait training will primarily consist of walking exercise under the supervision of an exercise physiologist.
Primary Outcome Measure Information:
Title
Number of patients with adverse events
Description
Adverse events will be collected throughout the study period to assess treatment safety.
Time Frame
through study completion, up to 16 weeks
Title
Percentage of training sessions missed.
Description
Training session attendance will be tracked as an indicator of feasibility throughout the treatment period.
Time Frame
through end of treatment, up to 9 weeks
Secondary Outcome Measure Information:
Title
Timed 25 Foot Walk
Description
Participants are instructed to walk as fast as possible but safely on a 25-foot straight course.
Time Frame
Week 0, Week 9 and week 16
Title
6-Minute Walk
Description
Participants are instructed to walk for 6 minutes.
Time Frame
Week 0, Week 9 and week 16
Title
Spatiotemporal gait parameters
Description
Gait parameters at self-selected pace will be collected on an electronic walkway.
Time Frame
Week 0, Week 9 and week 16
Title
MS Walking Scale - 12
Description
The MSWS-12 consists of 12 items inquiring about the impact of MS on various aspects of walking. Score range is from 0 to 100, with higher scores indicating a worse outcome.
Time Frame
Week 0, Week 9 and week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of MS based on 2017 revised McDonald criteria (relapsing or progressive course) Performs the T25FW in 8 to 30 seconds (cane(s), walking stick(s), crutch(es), or wheeled walker allowed) Exclusion Criteria: Physical therapy in the past 3 months or immediate need for PT due to safety concerns (e.g. falls) Requires at least one seated rest during the 6 MW test Treatment with high-dose corticosteroids in the past 2 months or planned during the study period Lower extremity botulinum toxin (BT) injections for spasticity in the past 3 months, or planned during the study period Initiation of an oral symptomatic therapy which could affect walking in the past 4 weeks (particularly dalfampridine and medications for spasticity) Initiation of a new disease-modifying therapy for MS in the past 3 months Comorbidity compromising safe participation or affecting walking (e.g. uncontrolled cardiac or respiratory illness, musculoskeletal disorder) Severe hearing impairment with or without the use of hearing aids, such that the participant cannot hear the rhythmic music stimulus consistently. Inability to walk safely to the rhythmic music stimulus during the baseline visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois Bethoux, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Rhythmic Auditory Stimulation & Gait Training

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