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

Official 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: DOUBLE
• Enrollment: 120 participants

Interventions

• DEVICE: Gait rehabilitation with "sonification" — The sonification system is composed by 2 inertial sensors, a computer and a pair of bluetooth headphones connected with the computer. The sensors will be placed one per leg at the ankle and connected with Matlab software. An home-made ad-hoc software associates patient's movements with music patterns. The patient's natural rhythm is detected and used at the beginning of the intervention. The first part of each exercise is supported by a pre-recorded chord progression with a click on the backgrou
• OTHER: Standard gait rehabilitation (without sonification) — The training will be carried out without any musical support. Exercises I Phase 1. Load shift in anteroposterior standing in tandem position, left foot forward (3 minutes exercise with a short break in the middle) 2. Load shift in anteroposterior standing in tandem position, right foot forward (3 minutes exercise with a short break in the middle) 3. Left foot swing (3 minutes exercise with a short break in the middle) 4. Right foot swing (3 minutes exercise with a short break in the middle) 5.

Primary Outcomes

• Change in the Six Minutes Walking Test (Change from Baseline Six Minutes Walking Test at 7 weeks)

Secondary Outcomes

• Mini BesTest (Up to 11 weeks)
• Dynamic Gait Index (Up to 11 weeks)
• Timed Up & Go (Up to 11 weeks)

Trial Locations

• Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy

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