Sonification Techniques for Gait Training: a Pilot Multicentric Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Istituti Clinici Scientifici Maugeri IRCCS
RECRUITING
Pavia
Contact Information
Primary
Paola Baiardi, PhD
paola.baiardi@icsmaugeri.it
+390382592599
Time Frame
Start Date: 2021-01-18
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 120
Treatments
Experimental: Gait rehabilitation with sonification
The rehabilitation exercises with sonification are supported by the musical component (see Interventions section for details).
Active_comparator: Standard gait rehabilitation (without sonification)
The same rehabilitation exercises are performed without musical support.
Sponsors
Leads: Istituti Clinici Scientifici Maugeri SpA

This content was sourced from clinicaltrials.gov