Multiple SclerosisNCT04314076
Rhythmic Auditory Stimulation & Gait Training
A study testing Rhythmic auditory stimulation and Gait Training in people with Multiple Sclerosis and Gait Disorders, Neurologic, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Gait Disorders, Neurologic
- What is being tested?
- Rhythmic auditory stimulation and Gait Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2020to 7 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Gait Disorders, Neurologic
- Being tested
- Rhythmic auditory stimulation, Gait Training
- Keywords
- Gait analysis, Music therapy, Multiple sclerosis
- Medical subject headings
- Multiple Sclerosis, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic auditory stimulationOther
Also called RAS
RAS, a Neurologic Music Therapy technique developed to utilize rhythm and timing cues to assist in improving the basic, intrinsic rhythmic movements of gait.
Gait TrainingOther
Also called GT
Continuous overground walking on a track for 30 minutes. Gait training will primarily consist of walking exercise under the supervision of an exercise physiologist.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Rhythmic auditory stimulation |
| 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 Receives: Other: Gait Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Adverse events will be collected throughout the study period to assess treatment safety.
Measured: 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.
Measured: through end of treatment, up to 9 weeks
Secondary outcomes (4)
Timed 25 Foot Walk
Participants are instructed to walk as fast as possible but safely on a 25-foot straight course.
Measured: Week 0, Week 9 and week 16
6-Minute Walk
Participants are instructed to walk for 6 minutes.
Measured: Week 0, Week 9 and week 16
Spatiotemporal gait parameters
Gait parameters at self-selected pace will be collected on an electronic walkway.
Measured: 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.
Measured: Week 0, Week 9 and week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start8 Jun 2020
- Primary completion7 Nov 2022
- Study completion7 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Consortium of Multiple Sclerosis Centers, MedRhythms, Inc.
- Responsible party
- Principal investigator, Francois Bethoux, MD, The Cleveland Clinic
- Investigators
- Francois Bethoux, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314076
- Sponsor's protocol ID
- #19-1590
- Status last verified
- Feb 2023
- First submitted
- 11 Mar 2020
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04314076
- Acronym / sponsor ID
- #19-1590
- Conditions
- Multiple Sclerosis, Gait Disorders, Neurologic
- Keywords
- Gait analysis, Music therapy, Multiple sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Consortium of Multiple Sclerosis Centers, MedRhythms, Inc.
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- a single blind parallel-group pilot randomized controlled trial comparing rhythmic auditory stimulation (RAS) with gait training to gait training without RAS.
| Arm | Type | Receives |
|---|---|---|
| Gait Training (GT) with Rhythmic Auditory Stimulation (RAS) | Active comparator | Other: Rhythmic auditory stimulationParticipants 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 | Other: Gait TrainingParticipants in this arm will complete 16 supervised gait training sessions consisting of continuous overground walking on a track for 30 minutes without RAS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhythmic auditory stimulationAlso: RASRAS, a Neurologic Music Therapy technique developed to utilize rhythm and timing cues to assist in improving the basic, intrinsic rhythmic movements of gait. | Other | Gait Training (GT) with Rhythmic Auditory Stimulation (RAS) |
| Gait TrainingAlso: GTContinuous overground walking on a track for 30 minutes. Gait training will primarily consist of walking exercise under the supervision of an exercise physiologist. | Other | Gait training (GT) without Rhythmic Auditory Stimulation (RAS) |
Primary outcome
Number of patients with adverse events
Time frame: 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.
Time frame: through end of treatment, up to 9 weeks
Training session attendance will be tracked as an indicator of feasibility throughout the treatment period.
4 secondary outcomes
Timed 25 Foot Walk
Time frame: Week 0, Week 9 and week 16
6-Minute Walk
Time frame: Week 0, Week 9 and week 16
Spatiotemporal gait parameters
Time frame: Week 0, Week 9 and week 16
MS Walking Scale - 12
Time frame: Week 0, Week 9 and week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois Bethoux, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythmic auditory stimulation and Gait Training in people with Multiple Sclerosis and Gait Disorders, Neurologic, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events (time frame: through study completion, up to 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.