Sonification Techniques for Gait Training
A legfontosabb adatok
- Hol
- Pavia (Olaszország)A helyszín megnézése
AI-kivonat: kiket keres a vizsgálat
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
A vizsgálat olyan felnőtteket keres, akik stroke-on estek át, vagy Parkinson-kórban vagy sclerosis multiplexben szenvednek, önállóan tudnak járni, de a járásuk megváltozott. Hanggal támogatott (szonifikációs) és hang nélküli járásgyakorlást hasonlít össze.
- Életkor
- Stroke és Parkinson-kór: 80 év alatt. Sclerosis multiplex: 60 év alatt.
- Nem
- Férfiak és nők egyaránt részt vehetnek.
- A betegség stádiuma
- Stroke: Modified Rankin Scale 1-3, egy agyféltekét érintő sérülés, az esemény után több mint 6 hónapja stabil állapot. Parkinson-kór: UPDRS III. rész pontszáma 28 alatt, stabil betegség. Sclerosis multiplex: EDSS pontszám 3-5, az elmúlt 6 hónapban nem volt shub.
- Korábbi kezelés
- Parkinson-kór: stabil gyógyszeres kezelés. A vizsgálat előtti évben nem volt zenével végzett rehabilitáció. Stroke és sclerosis multiplex: az előző 3 hónapban nem kaptak neurotoxint, és az előző héten nem kezdtek vagy módosítottak baclofent.
- Biomarker vagy leletérték
- Mini Mental State Examination pontszáma 24 felett.
A részvétel fő kizáró okai
- Stroke esetén több vagy kétoldali agyi sérülés, illetve neglect
- Az Ashworth-skálán 2 feletti spaszticitás (stroke és sclerosis multiplex)
- Az Achilles-ín merev, nem rugalmas megrövidülése
- Más, az alsó végtag működését akadályozó betegség
- A gyógyszeres kezelés megváltoztatása a vizsgálat alatt (Parkinson-kór)
Gépi kiolvasás: 2026. november 9.
Helyszínek itt: Olaszország
- Istituti Clinici Scientifici Maugeri IRCCSPavia, OlaszországRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
A vizsgálat adatai
- Ki végzi
- Istituti Clinici Scientifici Maugeri SpA
- Azonosító
- NCT04876339
- A regiszteradat frissítve
- 2026. július 2.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
Sonification Techniques for Gait Training: a Pilot Multicentric Randomized Controlled Trial
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.
Bevonási feltételek: 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; 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.
Kizáró feltételek: 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; Previous or concurrent diseases disabling the lower limb functions; Changes of drug therapy during 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; Multiple or bilateral lesions; Neglect; Equinism; Spasticity: Ashworth >2; Structured (non-elastic) Achilles tendon retraction; Rehabilitative treatments with music in the year before the study; Rehabilitative treatments with music in the year before the study; Spasticity: Ashworth >2; Structured (non-elastic) Achilles tendon retraction; Rehabilitative treatments with music in the year before the study.