RecruitingNot ApplicableNCT04876339

Sonification Techniques for Gait Training

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

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Enrollment

120 participants

Start Date

Jan 18, 2021

Study Type

INTERVENTIONAL

Conditions

Stroke Multiple Sclerosis Parkinson Disease

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

Max Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using sound cues (a technique called sonification — where movement is converted into real-time audio feedback) can help people with walking difficulties retrain and improve their gait. Participants include people who have had a stroke, people with Parkinson's disease, and people with multiple sclerosis. **You may be eligible if...** - You are under 80 years old (under 60 for MS patients) - You have had a stroke, Parkinson's disease, or multiple sclerosis with altered walking patterns - You can walk independently without aids or braces, even if your walking pattern is abnormal - Your disease has been stable for at least 6 months - You have good cognitive function (MMSE above 24) **You may NOT be eligible if...** - You have severe spasticity, a fixed Achilles tendon contracture, or use walking aids - You have had a recent change in muscle relaxant medications - You have had a previous limb or neurological condition that further impairs walking - You have already received a recent course of similar rehabilitation therapy Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGait 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 background. In the second part (sonification approach) the software notices and records the contact of the heel with the ground. Each contact activates musical stimuli listened to via headphones. The steps succession will build a regular and predictable musical progression in relation to the correct sequence of steps. The exercises planned in this intervention are the same as those planned in the gait standard rehabilitation (see below).

OTHERStandard 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. March in place (3 minutes exercise with a short break in the middle) Exercises II phase (15 minutes): the patient will perform 14 minutes of walking with a 1 minute of break in the middle (7 minutes of walking, 1 minute rest, 7 minutes of walking). In the second part of walking the patient will be asked to slightly increase the pace of the step up to the maximum possible speed.