Sonification Techniques for Gait Training
Recruiting · NCT04876339 · Interventional (participants receive a specific treatment) · Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
1 location listed.
- Istituti Clinici Scientifici Maugeri IRCCS - Pavia, Italy