NCT04876339 Sonification Techniques for Gait Training
| NCT ID | NCT04876339 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2021-01-18 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2021-01-18 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Alfredo Raglio, PhD
PRINCIPAL INVESTIGATOR
Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy
Frequently Asked Questions
Who can join the NCT04876339 clinical trial?
This trial is open to participants of all sexes, up to 80 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04876339 currently recruiting?
Yes, NCT04876339 is actively recruiting participants. Contact the research team at paola.baiardi@icsmaugeri.it for enrollment information.
Where is the NCT04876339 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT04876339 clinical trial?
NCT04876339 is sponsored by Istituti Clinici Scientifici Maugeri SpA. The principal investigator is Alfredo Raglio, PhD at Istituti Clinici Scientifici Maugeri IRCCS, Pavia, Italy. The trial plans to enroll 120 participants.
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