Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Consortium of Multiple Sclerosis Centers | OTHER |
| MedRhythms, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gait Training (GT) with Rhythmic Auditory Stimulation (RAS) | Active Comparator | Participants in this arm will complete 16 supervised gait training sessions consisting of continuous overground walking on a track for 30 minutes,with RAS |
|
| Gait training (GT) without Rhythmic Auditory Stimulation (RAS) | Other | Participants in this arm will complete 16 supervised gait training sessions consisting of continuous overground walking on a track for 30 minutes without RAS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rhythmic auditory stimulation | Other | RAS, a Neurologic Music Therapy technique developed to utilize rhythm and timing cues to assist in improving the basic, intrinsic rhythmic movements of gait. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | Adverse events will be collected throughout the study period to assess treatment safety. | through study completion, up to 16 weeks |
| Percentage of training sessions missed. | Training session attendance will be tracked as an indicator of feasibility throughout the treatment period. | through end of treatment, up to 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Timed 25 Foot Walk | Participants are instructed to walk as fast as possible but safely on a 25-foot straight course. | Week 0, Week 9 and week 16 |
| 6-Minute Walk | Participants are instructed to walk for 6 minutes. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Inability to walk safely to the rhythmic music stimulus during the baseline visit.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Francois Bethoux, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
a single blind parallel-group pilot randomized controlled trial comparing rhythmic auditory stimulation (RAS) with gait training to gait training without RAS.
Not provided
Not provided
A blinded examiner will be used to perform the gait analysis, 6 minute walk , and timed 25 foot walk
|
| Gait Training | Other | Continuous overground walking on a track for 30 minutes. Gait training will primarily consist of walking exercise under the supervision of an exercise physiologist. |
|
|
| Week 0, Week 9 and week 16 |
| Spatiotemporal gait parameters | Gait parameters at self-selected pace will be collected on an electronic walkway. | Week 0, Week 9 and week 16 |
| 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. | Week 0, Week 9 and week 16 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |