Using music to improve walking in patients with neurological conditions
Sonification Techniques for Gait Training: a Pilot Multicentric Randomized Controlled Trial
This study is testing if using music during walking exercises can help people with Parkinson's disease, stroke, and multiple sclerosis improve their walking better than regular rehab methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | N/A to 80 Years |
| Sex | All |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Locations | 1 site (Pavia) |
| Trial ID | NCT04876339 on ClinicalTrials.gov |
What this trial studies
This study explores the use of sonification techniques, which involve musical auditory cues, to enhance gait training in patients with Parkinson's disease, stroke, and multiple sclerosis. By providing auditory feedback that is pleasant and predictable, the study aims to improve sensorimotor learning and motor execution. Participants will undergo gait rehabilitation with sonification compared to standard rehabilitation methods. The effectiveness of this innovative approach will be assessed through various motor parameters.
Who should consider this trial
Good fit: Ideal candidates include individuals under 80 years old with Parkinson's disease, stroke, or multiple sclerosis who have stabilized conditions and specific gait impairments.
Not a fit: Patients with severe cognitive impairments or those over the age limits specified for each condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance rehabilitation outcomes for patients with neurological conditions by improving their gait and overall mobility.
How similar studies have performed: Previous studies have shown promising results using music therapy and sonification techniques in rehabilitation, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria (stroke patients) * Age \< 80 * Mini Mental State Examination \> 24 * Modified Rankin Scale: 1-3 * Single hemisphere lesion * Stabilized disease (\> 6 months after the acute event) * Impairment in gait parameters (e.g. velocity, perceived fatigue etc) * Motor independence during walking (without orthotic devices and aids) but with pathological pattern (spasticity level: Ashworth \< 2) Inclusion criteria (patients with Parkinson's disease) * Age \< 80 * Mini Mental State Examination \> 24 * Unified Parkinson Disease Rating Scale score (Parte III): \< 28 * Stabilized disease and drug therapy * Altered gait patterns * Motor independence during walking (without orthotic devices and aids) but with pathological pattern Inclusion criteria (patients with multiple sclerosis): * Age \< 60 * Mini Mental State Examination \> 24 * Expanded Disability Status Scale score: 3-5 * Stabilized disease in the last 6 months (without relapse or disability progression) * Altered gait patterns (i.e., careening, slowing down, spasticity: Ashworth \< 2, etc.) * Motor independence during walking Exclusion Criteria (stroke patients) * Multiple or bilateral lesions * Neglect * Equinism * Spasticity: Ashworth \>2 * Structured (non-elastic) Achilles tendon retraction * Neurotoxin in the 3 months prior to the study * Baclofen introduced or modified in the week before the start of the study * Previous or concurrent diseases disabling the lower limb functions * Rehabilitative treatments with music in the year before the study Exclusion criteria (patients with Parkinson's disease): * Previous or concurrent diseases disabling the lower limb functions * Changes of drug therapy during the study * Rehabilitative treatments with music in the year before the study Exclusion criteria (patients with multiple sclerosis): * Previous or concurrent diseases disabling the lower limb functions * Neurotoxin in the 3 months prior to the study * Baclofen introduced or modified in the week before the start of the study * Spasticity: Ashworth \>2 * Structured (non-elastic) Achilles tendon retraction * Rehabilitative treatments with music in the year before the study
Where this trial is running
Pavia
- Istituti Clinici Scientifici Maugeri IRCCS — Pavia, Italy (Recruiting)
Study contacts
- Principal investigator: Alfredo Raglio, PhD — Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy
- Study coordinator: Paola Baiardi, PhD
- Email: paola.baiardi@icsmaugeri.it
- Phone: +390382592599
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.