Multiple Sclerosis, Gait Disorders, Neurologic
Conditions
Keywords
Gait analysis, Music therapy, Multiple sclerosis
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.
Interventions
RAS, a Neurologic Music Therapy technique developed to utilize rhythm and timing cues to assist in improving the basic, intrinsic rhythmic movements of gait.
OTHERGait Training
Continuous overground walking on a track for 30 minutes. Gait training will primarily consist of walking exercise under the supervision of an exercise physiologist.
Sponsors
Consortium of Multiple Sclerosis Centers
MedRhythms, Inc.
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
A blinded examiner will be used to perform the gait analysis, 6 minute walk , and timed 25 foot walk
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse events | through study completion, up to 16 weeks | Adverse events will be collected throughout the study period to assess treatment safety. |
| Percentage of training sessions missed. | through end of treatment, up to 9 weeks | Training session attendance will be tracked as an indicator of feasibility throughout the treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed 25 Foot Walk | Week 0, Week 9 and week 16 | Participants are instructed to walk as fast as possible but safely on a 25-foot straight course. |
| 6-Minute Walk | Week 0, Week 9 and week 16 | Participants are instructed to walk for 6 minutes. |
| Spatiotemporal gait parameters | Week 0, Week 9 and week 16 | Gait parameters at self-selected pace will be collected on an electronic walkway. |
| MS Walking Scale - 12 | Week 0, Week 9 and week 16 | 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. |
Countries
United States
Outcome results
None listed