Gait Disturbance in Multiple Sclerosis PatientsPhase 2NCT01086371
Rhythmic Auditory Stimulation and Walking Performance in Multiple Sclerosis (MS) Patients
A Phase 2 study testing Rhythmic auditory stimulation and Walking exercise in people with Gait Disturbance in Multiple Sclerosis Patients, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The study is being conducted to determine if a home-based walking program that uses RAS (Rhythmic Auditory Stimulation)is a viable and effective treatment of gait instability for people with MS.We hypothesize that an RAS-based home walking program will demonstrate significant improvements over both regular exercise… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gait Disturbance in Multiple Sclerosis Patients
- What is being tested?
- Rhythmic auditory stimulation and Walking exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2012
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Diagnosis of multiple sclerosis documented in medical records
- Able to walk at least 100 feet without physical assistance (use of assistive devices such as cane, crutch, or walker is allowed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rhythmic Auditory Stimulation and Walking Performance in MS Patients
The study is being conducted to determine if a home-based walking program that uses RAS (Rhythmic Auditory Stimulation)is a viable and effective treatment of gait instability for people with MS.We hypothesize that an RAS-based home walking program will demonstrate significant improvements over both regular exercise and no exercise. To test this hypothesis we will compare between group differences from baseline and three weeks of intervention on 3 quantitative gait measures and 1 standardized MS measurement from the following 3 groups: RAS walking, RAS no walking Other: Walking exercise The secondary goal of the study will be to determine any carry-over effects of RAS on gait parameters in ambulatory patients with MS. We hypothesize that RAS will produce sustained changes in gait pattern due to entrainment processes. To test this hypothesis, we will compare gait parameters two weeks following the cessation of the intervention with baseline and with the last week of intervention.
The third goal of this study is to determine if RAS-enhanced exercise has any transfer to improve other areas such as upper extremity function and/or cognitive function. We hypothesize that those participating in an RAS-based home walking program will demonstrate improvements in other domain areas, such as cognitive and upper body functioning. To test this hypothesis we will compare results from the Multiple Sclerosis Functional Composite(MSFC) taken at baseline and again at the end of the treatment phase for all three groups.
Read the detailed description
Thirty three patients will be recruited for the study.There will be three study groups 1)the walking and music group,2)music only no walking group 3)walking only no music group The subjects in the walking + music group and the music - no walking group will be provided a list of songs to choose from. MP3 players will be provided that contain the chosen music, which has been altered electronically with an embedded beat and set to their baseline walking cadence +10%. The subjects in the walking + music group will be instructed to walk while listening to the music for 20 minutes per day every day. The subjects in the music - no walking group will be instructed to sit in a chair and listen to the music for 20 minutes per day every day. The subjects in the walking -no music group will be instructed to walk for 20 minutes per day every day. The total duration of the interventions will be 3 weeks.
Study schedule Visit 1 (baseline): informed consent will be obtained. Subjects will be screened for inclusion/exclusion criteria.Subjects qualified for the study will be randomized to the treatment (MT) or control (C) group. Baseline assessments will be performed on all subjects.Subjects in the walking+music group and the music- no walking group will be given mp3 players with music.
Visit 2 (week 3): assessments will be performed on all subjects.All subjects will be instructed to discontinue walking and music regimens.
Visit 3 (week 5): All subjects will return for final assessments.
- Being tested
- Rhythmic auditory stimulation, Walking exercise
- Keywords
- Multiple Sclerosis, gait
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic auditory stimulationOther
Also called Rythmic Auditory Stimulation, RAS, Music
Recorded music with embedded beat set 10% above the subject's baseline walking cadence.
Walking exerciseOther
Also called Walking
Subjects will be walking daily for a total of 20 minutes (may be broken down to smaller time periods.
| Study group | Role | What they receive |
|---|---|---|
| RAS walking | Experimental | Subjects will walk while listening to music 20 minutes per day every day during the study period. Receives: Other: Rhythmic auditory stimulation; Other: Walking exercise |
| RAS no walking | Active comparator | Subjects will be listening to music but not performing walking exercise, for 20 minutes per day every day during the study period. Receives: Other: Rhythmic auditory stimulation |
| Walking no RAS | Active comparator | Subjects will be walking without listening to music for 20 minutes per day every day during the study period Receives: Other: Walking exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stride Length
Measured: each study visit: baseline, week 3, and week 5 a total of 3 visits over a 5 week period of time
Secondary outcomes (1)
25 foot walk time
Measured: each study visit: baseline, week 3, and week 5 a total of 3 visits over a 5 week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study startJan 2012
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Study being redesigned in anticipation of new study protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Disturbance in Multiple Sclerosis PatientsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Francois Bethoux, MD, The Cleveland Clinic
- Investigators
- Francois A Bethoux, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086371
- Sponsor's protocol ID
- RAS Gait MS
- Status last verified
- Jun 2022
- First submitted
- 29 Jan 2010
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhythmic Auditory Stimulation and Walking Performance in MS Patients
- ClinicalTrials.gov ID
- NCT01086371
- Acronym / sponsor ID
- RAS Gait MS
- Keywords
- Multiple Sclerosis, gait
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study being redesigned in anticipation of new study protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jan 2012
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 15 Mar 2010 (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.
The study is being conducted to determine if a home-based walking program that uses RAS (Rhythmic Auditory Stimulation)is a viable and effective treatment of gait instability for people with MS.We hypothesize that an RAS-based home walking program will demonstrate significant improvements over both regular exercise and no exercise. To test this hypothesis we will compare between group differences from baseline and three weeks of intervention on 3 quantitative gait measures and 1 standardized MS measurement from the following 3 groups: RAS walking, RAS no walking Other: Walking exercise The secondary goal of the study will be to determine any carry-over effects of RAS on gait parameters in ambulatory patients with MS. We hypothesize that RAS will produce sustained changes in gait pattern due to entrainment processes. To test this hypothesis, we will compare gait parameters two weeks following the cessation of the intervention with baseline and with the last week of intervention.
The third goal of this study is to determine if RAS-enhanced exercise has any transfer to improve other areas such as upper extremity function and/or cognitive function. We hypothesize that those participating in an RAS-based home walking program will demonstrate improvements in other domain areas, such as cognitive and upper body functioning. To test this hypothesis we will compare results from the Multiple Sclerosis Functional Composite(MSFC) taken at baseline and again at the end of the treatment phase for all three groups.
Detailed description
Thirty three patients will be recruited for the study.There will be three study groups 1)the walking and music group,2)music only no walking group 3)walking only no music group The subjects in the walking + music group and the music - no walking group will be provided a list of songs to choose from. MP3 players will be provided that contain the chosen music, which has been altered electronically with an embedded beat and set to their baseline walking cadence +10%. The subjects in the walking + music group will be instructed to walk while listening to the music for 20 minutes per day every day. The subjects in the music - no walking group will be instructed to sit in a chair and listen to the music for 20 minutes per day every day. The subjects in the walking -no music group will be instructed to walk for 20 minutes per day every day. The total duration of the interventions will be 3 weeks.
Study schedule Visit 1 (baseline): informed consent will be obtained. Subjects will be screened for inclusion/exclusion criteria.Subjects qualified for the study will be randomized to the treatment (MT) or control (C) group. Baseline assessments will be performed on all subjects.Subjects in the walking+music group and the music- no walking group will be given mp3 players with music.
Visit 2 (week 3): assessments will be performed on all subjects.All subjects will be instructed to discontinue walking and music regimens.
Visit 3 (week 5): All subjects will return for final assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RAS walking | Experimental | Other: Rhythmic auditory stimulation, Other: Walking exerciseSubjects will walk while listening to music 20 minutes per day every day during the study period. |
| RAS no walking | Active comparator | Other: Rhythmic auditory stimulationSubjects will be listening to music but not performing walking exercise, for 20 minutes per day every day during the study period. |
| Walking no RAS | Active comparator | Other: Walking exerciseSubjects will be walking without listening to music for 20 minutes per day every day during the study period |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Diagnosis of multiple sclerosis documented in medical records
- Able to walk at least 100 feet without physical assistance (use of assistive devices such as cane, crutch, or walker is allowed.
Key exclusion criteria (3 listed)
- 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
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: Rythmic Auditory Stimulation, RAS, MusicRecorded music with embedded beat set 10% above the subject's baseline walking cadence. | Other | RAS no walking, RAS walking |
| Walking exerciseAlso: WalkingSubjects will be walking daily for a total of 20 minutes (may be broken down to smaller time periods. | Other | RAS walking, Walking no RAS |
Primary outcome
Stride Length
Time frame: each study visit: baseline, week 3, and week 5 a total of 3 visits over a 5 week period of time
1 secondary outcome
25 foot walk time
Time frame: each study visit: baseline, week 3, and week 5 a total of 3 visits over a 5 week period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
Related trials for Gait Disturbance in Multiple Sclerosis Patients
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Gait Pattern and Its Relation to Cognition and VEP in Multiple Sclerosis
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RecruitingObservational study
"Balance, Gait, and Motion Analysis in Multiple Sclerosis"
Multiple Sclerosis, Gait Disorders, Neurologic
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 Phase 2 study testing Rhythmic auditory stimulation and Walking exercise in people with Gait Disturbance in Multiple Sclerosis Patients, 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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 27 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Stride Length (time frame: each study visit: baseline, week 3, and week 5 a total of 3 visits over a 5 week period of time). 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 27 Jun 2022.