Sonification Techniques for Gait Training (SonicWalk)

April 1, 2026 updated by: Istituti Clinici Scientifici Maugeri SpA

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:

Music therapy is widely used in relational settings. The sound can engage limbic and paralimbic areas and a variety of other brain areas strictly connected with movement (motor cortex, supplementary motor area, cerebellum, basal ganglia, etc.). For this reason, music can be considered a useful tool in rehabilitation settings and, in particular, for neuromotor rehabilitation.

The use of specific music-based techniques can induce plastic changes from childhood to elderly. These changes involve both brain motor and auditory sensory-motor areas thanks to the improved connectivity between brain areas induced by the sound and music that would not happen without the auditory stimuli. As suggested in previous studies the plastic changes induced by music in the nodal points of the cerebral network can cause effects that tend to persist even beyond the duration of rehabilitation training. The music also in the rehabilitation process determines an emotional involvement and creates a strong motivational basis reinforcing its action through the coupling of the auditory stimulus with sensory-motor component.

Neurologic Music Therapy (NTM) could be defined as a codified use of music-based techniques aimed at recovering sensory, cognitive and motor deficits due to a neurological pathology. NMT consists in several specific techniques among which Rhythmic Auditory Stimulation (RAS) is one of the most used and well documented in scientific literature. RAS is based on the application of the rhythmic component of the music to gait and gait-related rehabilitation. Music effects in stroke rehabilitation are well documented: music can improve gait (velocity, cadence, stride length and balance), upper limbs movements , language, but also mood and psychological aspects.

Gait rehabilitation studies for Parkinson's Disease (PD) and Multiple Sclerosis (MS) show similar results.

Recent studies are related to the "sonification" technique: a properly selected set of sonorous-music stimuli are associated with patient movements mapping. 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. Studies related to "sonification" mainly concern upper limb rehabilitation and only a few of them concern the lower limbs rehabilitation. In particular, 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 this particular kind of sonification to gait training and other secondary outcomes in stroke, PD and SM population.

Aims:

  1. To assess the effectiveness of the sonification in the gait rehabilitation in stroke, PD and MS patients.
  2. To assess the effectiveness of sonification on the level of fatigue perceived during the rehabilitation process
  3. To assess the impact of the sonification on the quality of life

Materials and methods:

The study is a multicenter randomized controlled trial and will involve 120 clinically stabilized patients with stroke (n=40), Parkinsons' disease (n=40) and multiple sclerosis (n=40). Each of these three arms will be divided in two groups: a control group (n=20) will undergo standard motor rehabilitation and an experimental group (n=20) will undergo the same rehabilitation but with the sonification support. The gait training program includes 20 sessions, 30 minutes each 3 times a week (see next chapter for details).

A unique randomization list will be generated according to the trial's design and managed by the Principal Investigator. Each subject will be associated with a unique identifier that will allow its identification throughout the duration of the study. The evaluation of the questionnaires and the statistical analysis will be carried out blindly

Assessment:

The interventions will be evaluated at the baseline (T0), after 10 sessions (T1), after 20 sessions (T2, end of the treatment) and at follow-up (T3, one month after the end of the treatment). The scales used for the assessments will be the following:

Functional evaluation:

- Functional Independence Measure (FIM)

Motor parameter evaluation:

  • 6 minutes Walking Test (velocity)
  • Mini BesTest (balance)
  • Dynamic Gait Index (dynamic balance, gait and risk of falls)
  • Timed Up & Go (mobility)

Fatigue assessments, quality of life and perceived overall effect of the intervention:

  • VAS (Visual Analogue Scale, for assessing perceived fatigue at the end of each session)
  • McGill Quality of Life- it (quality of life assessment)
  • Global Perceived Effect (GPE) Statistics The collected data will be presented by descriptive statistics: continuous variables having a normal distribution as mean and standard deviation, continuous variables having a non-normal distribution as median and interquartile range. Binary and categorical variables will be presented as a percentage or absolute number.

For each group of patients involved in this study (stroke, Parkinson's disease, multiple sclerosis), the homogeneity of demographic data and outcome measures between the experimental subgroup and the control subgroup will be verified. Finally, for all outcome measures detected (6 minutes Walking Test, FIM, Dynamic Gait Index, Timed Up & Go, VAS fatigue, McGill Quality of Life-it and GPE) it is expected to perform the analysis of the variance or mixed linear model for repeated measurements (p<0.05) in order to evaluate the effects of the treatment type, time and their interaction. For those outcomes where the assumptions of applicability of the variance analysis will not be verified, non-parametric methods will be applied to assess the main effects and interaction separately.

Patients will be asked to sign an Informed Consent before joining the study.

Adverse events No indication of any risk associated with the protocol because the rehabilitative treatments will be performed according to the usual procedures laid down in clinical practice in accordance with the guidelines relating to the gait rehabilitation.

Informed consent to participate in the study. All patients participating in the study will have to give their informed consent as required by the attachment for the execution of the study and for the processing of personal data.

Insurance The activation of an additional insurance is not foreseen as the study and the procedures applied fall within the coverage of the insurance policy currently in force for the conduct of the clinical trial.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gait rehabilitation with "sonification"
The rehabilitation exercises with sonification are supported by the musical component (see "Interventions" section for details).
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 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).
Active Comparator: Standard gait rehabilitation (without sonification)
The same rehabilitation exercises are performed without musical support.
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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Six Minutes Walking Test
Time Frame: Change from Baseline Six Minutes Walking Test at 7 weeks
The gait speed will be evaluated (using the Six Minutes Walking Test) by comparing the variations of the test scores in the experimental and control group
Change from Baseline Six Minutes Walking Test at 7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini BesTest
Time Frame: Up to 11 weeks
The balance will be evaluated (using the Mini BesTest) by comparing the variations of the test scores in the experimental and control group
Up to 11 weeks
Dynamic Gait Index
Time Frame: Up to 11 weeks
Dynamic balance and gait and risk of falls will be evaluated (using the Dynamic Gait Index) by comparing the variations of the test scores in the experimental and control group
Up to 11 weeks
Timed Up & Go
Time Frame: Up to 11 weeks
The mobility will be evaluated (using the Timed Up & Go test) by comparing the variations of the test scores in the experimental and control group
Up to 11 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
McGill Quality of Life- it
Time Frame: Up to 11 weeks
Quality of Life will be evaluated (using the McGill Quality of Life- it) by comparing the variations of the test scores in the experimental and control group
Up to 11 weeks
Global Perceived Effect
Time Frame: Up to 11 weeks
The overall effect of the intervention will be evaluated (using the Global Perceived Effect) by comparing the variations of the test scores in the experimental and control group
Up to 11 weeks
Visual Analogue Scale
Time Frame: Up to 11 weeks
The fatigue perceived will be evaluated (using a Visual Analogue Scale) by comparing the variations of the test scores in the experimental and control group
Up to 11 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Investigators

  • Principal Investigator: Alfredo Raglio, PhD, Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

May 3, 2021

First Posted (Actual)

May 6, 2021

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2419 CE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Gait rehabilitation with "sonification"

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe