Multiple SclerosisNCT02065284
Effects of a Home Based Walking Program Using Rhythmic Auditory Stimulation in Patients With Multiple Sclerosis
A study testing Rhythmic Auditory Stimulation (RAS) in people with Multiple Sclerosis and Ambulation Difficulty, run by The Cleveland Clinic at 1 site in United States.
Trial summary
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 purpose of this study is to compare the effect on walking performance of a home based walking program (HBWP) with Rhythmic Auditory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Ambulation Difficulty
- What is being tested?
- Rhythmic Auditory Stimulation (RAS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Nov 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years or older
- diagnosis of MS per Mc Donald criteria
- Ambulation Index score from 2 to 6 inclusive (clinically observable gait disturbance, whether the subject walks with no, unilateral, or bilateral support)
- spastic paresis is the main neurologic impairment causing the gait disturbance, per investigator's judgment.
Who cannot join
- neurologic impairments other than spastic paresis (e.g. cerebellar ataxia or sensory ataxia), or non-neurologic impairments (e.g. musculoskeletal problems) play a major role in the subject's gait disturbance, per investigator's judgment;
- treatment for an MS exacerbation in the past 30 days;
- severe co morbidity precluding participation in the study per investigator's judgment (e.g. severe cardiac or respiratory failure);
- severe cognitive deficits precluding informed consent or preventing the subject from following study procedures safely
- contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc.
- pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Neurological Institute Mellen Center
Cleveland, Ohio, 44195
About this study
Official title: Effects of a Home Based Walking Program Using Rhythmic Auditory Stimulation on Walking and Cortical Activation in Patients With Multiple Sclerosis.
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 purpose of this study is to compare the effect on walking performance of a home based walking program (HBWP) with Rhythmic Auditory Stimulation (RAS), to that of a HBWP without RAS, or to RAS without walking exercise.
A second part of this study will assess the effects of Rhythmic Auditory Stimulation (RAS) on brain activity in patients with Multiple Sclerosis while performing mental imagery of walking.
- Conditions
- Multiple Sclerosis, Ambulation Difficulty
- Being tested
- Rhythmic Auditory Stimulation (RAS)
- Keywords
- MS, Ambulation
- Medical subject headings
- Multiple Sclerosis, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic Auditory Stimulation (RAS)Other
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Walking-Rhythmic Auditory Stimulation | Active comparator | Walking daily with Rhythmic Auditory Stimulation (RAS) based music for 4 weeks Receives: Other: Rhythmic Auditory Stimulation (RAS) |
| Walking- only | Active comparator | Walking daily with no Rhythmic Auditory Stimulation (RAS) based music for 4 weeks Receives: Other: Rhythmic Auditory Stimulation (RAS) |
| Rhythmic Auditory Stimulation (RAS)only | Active comparator | Listening to based music only daily for 4 weeks Receives: Other: Rhythmic Auditory Stimulation (RAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved gait pattern on gait analysis
To compare the effect on gait pattern of a walking program with Rhythmic Auditory Stimulation, to that of a walking program without Rhythmic Auditory Stimulation, or Rhythmic Auditory Stimulation without walking exercise.
Measured: 8 weeks
Secondary outcomes (2)
Improved walk time on the timed 25 foot walk test
To compare the effect on walking performance of a walking program with Rhythmic Auditory Stimulation, to that of a walking program without Rhythmic Auditory Stimulation, or Rhythmic Auditory Stimulation without walking exercise.
Measured: 8 weeks
Improved distance on the 2 minute walk test
To compare the effect on walking performance of a walking program with Rhythmic Auditory Stimulation, to that of a walking program without Rhythmic Auditory Stimulation, or Rhythmic Auditory Stimulation without walking exercise.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- The Kelvin and Eleanor Smith Foundation
- Responsible party
- Sponsor
- Investigators
- Francois A Bethoux, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065284
- Sponsor's protocol ID
- HBWP and RAS
- Status last verified
- Jun 2022
- First submitted
- 13 Feb 2014
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Conklyn D, Stough D, Novak E, Paczak S, Chemali K, Bethoux F. A home-based walking program using rhythmic auditory stimulation improves gait performance in patients with multiple sclerosis: a pilot study. Neurorehabil Neural Repair. 2010 Nov-Dec;24(9):835-42. doi: 10.1177/1545968310372139. Epub 2010 Jul 19.
PubMed 20643882
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Home Based Walking Program Using Rhythmic Auditory Stimulation on Walking and Cortical Activation in Patients With Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT02065284
- Acronym / sponsor ID
- HBWP and RAS
- Conditions
- Multiple Sclerosis, Ambulation Difficulty
- Keywords
- MS, Ambulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- The Kelvin and Eleanor Smith Foundation
- Study start
- Feb 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 19 Feb 2014 (estimated)
- 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.
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 purpose of this study is to compare the effect on walking performance of a home based walking program (HBWP) with Rhythmic Auditory Stimulation (RAS), to that of a HBWP without RAS, or to RAS without walking exercise.
A second part of this study will assess the effects of Rhythmic Auditory Stimulation (RAS) on brain activity in patients with Multiple Sclerosis while performing mental imagery of walking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Walking-Rhythmic Auditory Stimulation | Active comparator | Other: Rhythmic Auditory Stimulation (RAS)Walking daily with Rhythmic Auditory Stimulation (RAS) based music for 4 weeks |
| Walking- only | Active comparator | Other: Rhythmic Auditory Stimulation (RAS)Walking daily with no Rhythmic Auditory Stimulation (RAS) based music for 4 weeks |
| Rhythmic Auditory Stimulation (RAS)only | Active comparator | Other: Rhythmic Auditory Stimulation (RAS)Listening to based music only daily for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 years or older
- diagnosis of MS per Mc Donald criteria
- Ambulation Index score from 2 to 6 inclusive (clinically observable gait disturbance, whether the subject walks with no, unilateral, or bilateral support)
- spastic paresis is the main neurologic impairment causing the gait disturbance, per investigator's judgment.
Key exclusion criteria (6 listed)
- neurologic impairments other than spastic paresis (e.g. cerebellar ataxia or sensory ataxia), or non-neurologic impairments (e.g. musculoskeletal problems) play a major role in the subject's gait disturbance, per investigator's judgment;
- treatment for an MS exacerbation in the past 30 days;
- severe co morbidity precluding participation in the study per investigator's judgment (e.g. severe cardiac or respiratory failure);
- severe cognitive deficits precluding informed consent or preventing the subject from following study procedures safely
- contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc.
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 Stimulation (RAS)Also: RASRhythmic Auditory Stimulation (RAS) is a music therapy technique that provides rhythmic auditory cues (like a beat) to help improve patients' movements, especially when walking. | Other | Rhythmic Auditory Stimulation (RAS)only, Walking- only, Walking-Rhythmic Auditory Stimulation |
Primary outcome
Improved gait pattern on gait analysis
Time frame: 8 weeks
To compare the effect on gait pattern of a walking program with Rhythmic Auditory Stimulation, to that of a walking program without Rhythmic Auditory Stimulation, or Rhythmic Auditory Stimulation without walking exercise.
2 secondary outcomes
Improved walk time on the timed 25 foot walk test
Time frame: 8 weeks
Improved distance on the 2 minute walk test
Time frame: 8 weeks
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 21 Jun 2022.
- Background: PubMed 20643882Conklyn D, Stough D, Novak E, Paczak S, Chemali K, Bethoux F. A home-based walking program using rhythmic auditory stimulation improves gait performance in patients with multiple sclerosis: a pilot study. Neurorehabil Neural Repair. 2010 Nov-Dec;24(9):835-42. doi: 10.1177/1545968310372139. Epub 2010 Jul 19.
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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 A 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 (RAS) in people with Multiple Sclerosis and Ambulation Difficulty, 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 4 inclusion and 6 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 21 Jun 2022. 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?
Improved gait pattern on gait analysis (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02065284, which also lists 1 linked publication.
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 21 Jun 2022; AzTrials last refreshed its copy on 26 Oct 2026.