Effects of a Home Based Walking Program Using Rhythmic Auditory Stimulation in Patients With Multiple Sclerosis

NeuroTherapia, Inc.

Status: Completed

Conditions: Ambulation Difficulty; Multiple Sclerosis

Treatments: Other: Rhythmic Auditory Stimulation (RAS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02065284

HBWP and RAS

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age 18 years or older
2. diagnosis of MS per Mc Donald criteria
3. Ambulation Index score from 2 to 6 inclusive (clinically observable gait disturbance, whether the subject walks with no, unilateral, or bilateral support)
4. spastic paresis is the main neurologic impairment causing the gait disturbance, per investigator's judgment.

Exclusion criteria

1. 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;
2. treatment for an MS exacerbation in the past 30 days;
3. severe co morbidity precluding participation in the study per investigator's judgment (e.g. severe cardiac or respiratory failure);
4. severe cognitive deficits precluding informed consent or preventing the subject from following study procedures safely
5. contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc.
6. pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 3 patient groups

Walking-Rhythmic Auditory Stimulation

Active Comparator group

Description:

Walking daily with Rhythmic Auditory Stimulation (RAS) based music for 4 weeks

Treatment:

Other: Rhythmic Auditory Stimulation (RAS)

Walking- only

Active Comparator group

Description:

Walking daily with no Rhythmic Auditory Stimulation (RAS) based music for 4 weeks

Treatment:

Other: Rhythmic Auditory Stimulation (RAS)

Rhythmic Auditory Stimulation (RAS)only

Active Comparator group

Description:

Listening to based music only daily for 4 weeks

Treatment:

Other: Rhythmic Auditory Stimulation (RAS)