Sonification Techniques for Gait Training

NCT04876339 | Recruiting

• 1 other identifier: 2419 CE
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease; Stroke; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change in the Six Minutes Walking Test

  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 Outcomes (3)

• Mini BesTest

  Up to 11 weeks

• Dynamic Gait Index

  Up to 11 weeks

• Timed Up & Go

  Up to 11 weeks

Other Outcomes (3)

• McGill Quality of Life- it

  Up to 11 weeks

• Global Perceived Effect

  Up to 11 weeks

• Visual Analogue Scale

  Up to 11 weeks

Study Arms (2)

Gait rehabilitation with "sonification"

EXPERIMENTAL

The rehabilitation exercises with sonification are supported by the musical component (see "Interventions" section for details).

Device: Gait rehabilitation with "sonification"

Standard gait rehabilitation (without sonification)

ACTIVE COMPARATOR

The same rehabilitation exercises are performed without musical support.

Other: Standard gait rehabilitation (without sonification)

Interventions

Gait rehabilitation with "sonification" DEVICE

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).

Gait rehabilitation with "sonification"

Standard gait rehabilitation (without sonification) OTHER

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.

Standard gait rehabilitation (without sonification)

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Scientifici Maugeri IRCCS

Pavia, 27100, Italy

RECRUITING

Related Publications (46)

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  BACKGROUND

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MeSH Terms

Conditions

Parkinson Disease; Stroke; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Alfredo Raglio, PhD

  Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Baiardi, PhD

CONTACT

+390382592599; paola.baiardi@icsmaugeri.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 6, 2021
• Study Start: January 18, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 2, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)