Sonification Techniques for Gait Training (NCT04876339) | Clinical Trial Compass
RecruitingNot Applicable
Sonification Techniques for Gait Training
Italy120 participantsStarted 2021-01-18
Plain-language 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.
Who can participate
Age range
80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 treatmen…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the Six Minutes Walking Test
Timeframe: Change from Baseline Six Minutes Walking Test at 7 weeks