Clinical trial NCT04314076: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Gait Disorders, Neurologic
Keywords: Gait analysis
Music therapy
Multiple sclerosis
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Consortium of Multiple Sclerosis Centers
name: MedRhythms, Inc.
First posted: 2020-03-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a single blind parallel-group pilot randomized controlled trial comparing rhythmic auditory stimulation (RAS) with gait training to gait training without RAS.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: through study completion, up to 16 weeks
measure: Percentage of training sessions missed.
timeFrame: through end of treatment, up to 9 weeks
Secondary outcomes:
measure: Timed 25 Foot Walk
timeFrame: Week 0, Week 9 and week 16
measure: 6-Minute Walk
timeFrame: Week 0, Week 9 and week 16
measure: Spatiotemporal gait parameters
timeFrame: Week 0, Week 9 and week 16
measure: MS Walking Scale - 12
timeFrame: Week 0, Week 9 and week 16
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Francois Bethoux, MD
role: PRINCIPAL_INVESTIGATOR
References: