Actively Recruiting

Phase Not Applicable
Age: 0 - 80Years
All Genders
NCT04876339

Sonification Techniques for Gait Training

Led by Istituti Clinici Scientifici Maugeri SpA · Updated on 2026-04-02

120

Participants Needed

1

Research Sites

336 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Sonification Techniques for Gait Training

Who Can Participate

Age: 0 - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Stroke patients younger than 80 years
  • Mini Mental State Examination score greater than 24
  • Modified Rankin Scale between 1 and 3
  • Single hemisphere lesion and stabilized disease for more than 6 months
  • Impaired gait parameters and motor independence during walking without aids (spasticity Ashworth less than 2)
  • Parkinson's disease patients younger than 80 years
  • Mini Mental State Examination score greater than 24
  • Unified Parkinson Disease Rating Scale (Part III) score less than 28
  • Stabilized disease and drug therapy with altered gait and motor independence without aids
  • Multiple sclerosis patients younger than 60 years
  • Mini Mental State Examination score greater than 24
  • Expanded Disability Status Scale score between 3 and 5
  • Stabilized disease in last 6 months without relapse or disability progression
  • Altered gait and motor independence during walking
Not Eligible

You will not qualify if you...

  • Stroke patients with multiple or bilateral lesions
  • Neglect or equinism
  • Spasticity Ashworth greater than 2
  • Structured (non-elastic) Achilles tendon retraction
  • Neurotoxin treatment in the 3 months prior to study
  • Baclofen introduced or changed in the week before study
  • Diseases disabling lower limb functions
  • Rehabilitation treatments with music in the year before study
  • Parkinson's disease patients with diseases disabling lower limb functions
  • Changes in drug therapy during study
  • Rehabilitation treatments with music in the year before study
  • Multiple sclerosis patients with diseases disabling lower limb functions
  • Neurotoxin treatment in the 3 months prior to study
  • Baclofen introduced or changed in the week before study
  • Spasticity Ashworth greater than 2
  • Structured (non-elastic) Achilles tendon retraction
  • Rehabilitation treatments with music in the year before study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Istituti Clinici Scientifici Maugeri IRCCS

Pavia, Italy, 27100

Actively Recruiting

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Research Team

P

Paola Baiardi, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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