NCT04876339Recruiting
Sonification Techniques for Gait Training
Sonification Techniques for Gait Training: a Pilot Multicentric Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 2 Jul 2026
Brief summary (registry, in English)
Music therapy is widely used in relational and rehabilitation settings. In addition to Neurologic Music Therapy and other music-based techniques, "sonification" approaches were recently introduced in the field of rehabilitation. The "sonification" can be defined as a properly selected set of sonorous-music stimuli are associated with patient movements mapping. In fact, the auditory-motor feedback can replace damaged proprioceptive circuits with a consequent improvement of the rehabilitation process. Interventions with "sonification" facilitate sensorimotor learning, proprioception and movements planning and execution improving global motor parameters. This study proposes the use of musical auditory cues which includes the melodic-harmonic component of the music. This kind of sonification makes the feedback pleasant and predictable as well as potentially effective. The investigators propose to apply and assess the effectiveness of this kind of sonification on gait training and other secondary outcomes in stroke, Parkinson's disease and multiple sclerosis population. Also, the investigators will assess the impact of "sonification" on the level of fatigue perceived during the rehabilitation process and on the quality of life. The study is a multicenter randomized controlled trial and will involve 120 patients that will undergo standard motor rehabilitation or the same rehabilitation but with the sonification support. The interventions will be evaluated at the baseline, after 10 sessions, after 20 sessions and at follow-up (one month after the end of the treatment). The assessment will include functional, motor, fatigue and quality of life evaluations. The collected data will be statistically processed.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 26 Apr 2021
- Start date
- 18 Jan 2021
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Diseases
- Stroke, Parkinson disease, Multiple sclerosis
- NCT number
- NCT04876339
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 18 Jan 2021 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Previous or concurrent diseases disabling the lower limb functions
- Changes of drug therapy during the study
- 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
Other
- Multiple or bilateral lesions
- Neglect
- Equinism
- Spasticity: Ashworth \>2
- Structured (non-elastic) Achilles tendon retraction
- Rehabilitative treatments with music in the year before the study
- Rehabilitative treatments with music in the year before the study
- Spasticity: Ashworth \>2
- Structured (non-elastic) Achilles tendon retraction
- Rehabilitative treatments with music in the year before the study
Who the study is looking for
- 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)
- 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
- 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
Age in the registry: - to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituti Clinici Scientifici Maugeri IRCCS Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.