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Search / Trial NCT04876339

Sonification Techniques for Gait Training

Launched by ISTITUTI CLINICI SCIENTIFICI MAUGERI SPA · May 3, 2021

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial, titled "Sonification Techniques for Gait Training," is exploring a new approach to help people with Parkinson's disease, stroke, and multiple sclerosis improve their walking abilities through music. The researchers are testing a method called "sonification," which involves using musical sounds to give feedback during movement. This can help patients retrain their bodies to move better by replacing some of the lost sensations that help us know where our body is in space. The study will involve 120 participants who will either receive standard rehab or rehab enhanced with musical cues over several sessions.

To be eligible for the trial, participants generally need to be under 80 years old, have a stable condition for at least six months, and be able to walk independently (without walking aids). They should also have some difficulties with walking. Participants can expect to undergo assessments at the start of the study, after completing treatment, and a month later to see how well the music-based therapy works in improving their walking, reducing fatigue, and enhancing their overall quality of life. This research could potentially offer a new way to support rehabilitation through engaging and pleasant musical experiences.

Gender

ALL

Eligibility criteria

  • 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

About Istituti Clinici Scientifici Maugeri Spa

Istituti Clinici Scientifici Maugeri S.p.A. is a prestigious Italian healthcare organization dedicated to advancing medical research and clinical practice. With a strong focus on patient-centered care, the institution integrates innovative clinical trials into its comprehensive services, fostering collaboration between researchers and healthcare professionals. Known for its commitment to high-quality standards and ethical practices, Istituti Clinici Scientifici Maugeri S.p.A. plays a pivotal role in the development of new therapies and treatment modalities, contributing significantly to the global medical community and enhancing patient outcomes.

Locations

Pavia, , Italy

Patients applied

0 patients applied

Trial Officials

Alfredo Raglio, PhD

Principal Investigator

Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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