Rhythmic Auditory Stimulation & Gait Training
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
We could not find results for this trial
What it found
We found no results in the registry or in papers.
This trial finished 3 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Rhythmic auditory stimulation
- Gait Training
What it measured
Main measures
Number of patients with adverse events
through study completion, up to 16 weeks
SafetyPercentage of training sessions missed.
through end of treatment, up to 9 weeks
Feasibility
Other measures (4)
Timed 25 Foot Walk
Week 0, Week 9 and week 16
Disability progressionWalking and mobility6-Minute Walk
Week 0, Week 9 and week 16
Walking and mobilitySpatiotemporal gait parameters
Week 0, Week 9 and week 16
Walking and mobilityMS Walking Scale - 12
Week 0, Week 9 and week 16
Walking and mobility
Who could take part
MS (type not specified) · 18 to 65
Show the full criteria
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Jun 2020
Main results due
Nov 2022
Finished
Nov 2022