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Universidad de Salud y Ciencia de OregónMobility in Daily Life and Falls in Parkinson's Disease: Potential for Rehabilitation
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El estudio clínico NCT04897256 es un ensayo intervencionista para Enfermedad de Parkinson. Su estado actual es: activo, no reclutando. El ensayo se inició el 13 de septiembre de 2021, con el objetivo de reclutar a 55 participantes. Dirigido por la Universidad de Salud y Ciencia de Oregón, se espera que finalice el 1 de junio de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 17 de noviembre de 2025.
Resumen
The goal of this intervention is to explore the effectiveness of a Turning Intervention (TURN-IT) to improve quality of turning in participants with Parkinson's Disease (PD). An unique exercise program has been developed - TURN-IT - in which participants practice exercises that focus on physiological constraints that impair turning ability, such as axial rigidity, narrow base of support, bradykinesia, and inflexible set-shifting. The 60 participants with PD and a history of falls in the previous 12 months, will be randomized into a 6-week, 3x/week, one-on-one TURN-IT group or No-Intervention Control group. This pilot intervention study will determine the number of subjects needed for a future clinical trial and will determine the sensitivity to change with rehabilitation our daily-life turning quality measures (such as, mean and variability of number of steps to turn, turn amplitude, turn velocity). The investigators predict that the TURN-IT program will improve turning in daily life enough to justify a larger clinical trial.
Título oficial
Mobility in Daily Life and Falls in Parkinson's Disease: Potential for Rehabilitation
Condiciones médicas
Enfermedad de ParkinsonPublicaciones
Artículos científicos y trabajos de investigación publicados sobre este ensayo clínico:Otros ID del ensayo
Número del NCT
Inicio del ensayo (real)
2021-09-13
Última actualización
2025-11-17
Fecha de finalización (estimada)
2026-06-01
Inscripción (prevista)
55
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Activo, no reclutando
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Simple
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalTURN-IT group Participants in the treatment group will attend supervised, 1-hour classes, 3 times per week for 6 weeks, one-on-one with the same exercise trainer, overseen by a physical therapist investigator. | TURN-IT Exercise Program Based on the exercise motor learning principles, participants spend 10-15 minutes at each Exercise Station that focuses on particular constraints of turning ability. The stations will focus on important underlying aspects of turning, such as weight-shifting and increasing axial rotation during functional turning tasks. Each station will be progressed across levels to make more challenging (such as adding a dual task). Initially participants will be supported in an overhead body-weight support system (ZeroG) to allow them to practice challenging exercises without the risk of falling. |
Sin intervenciónNo Intervention Control Group Participants in this group will be tested at baseline and 6 weeks later. They will go about their normal daily life during the 6 week period. | N/A |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Change in variability in number of steps to complete a turn | Coefficient of variation in the number of steps in a turn, averaged from daily monitoring | 6 weeks |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Change in Falls Efficacy Scale International | A 16 item self-administered questionnaire to assess fear of falling. Score range 16-64 with higher score indicating more fear of falling | 6 weeks |
Change in prospective fall rate | Number of prospective falls recorded for 12 months starting from the end of intervention | 52 weeks |
Change in patient global impression of change | Question of participant's rating of mobility. Score range from 1-7 with 1-3 indicating improvement, 4 no change, and 5-7 worsening of mobility | 6 weeks |
Change in number of steps to complete a turn | Number of steps in a turning averaged from daily monitoring | 6 weeks |
Change in turn peak velocity | Peak velocity of turns averaged from daily monitoring | 6 weeks |
Change in turn angle amplitude | Peak size of turn angles averaged from daily monitoring | 6 weeks |
Change in turn duration | Time to complete turns averaged from daily monitoring | 6 weeks |
Change in turn trunk jerk | A measure of smoothness of turning; the rate of change of acceleration during a turn averaged from daily monitoring | 6 weeks |
Change in variability of double-support time | Coefficient of variation in time of double-support phase | 6 weeks |
Change in lateral trunk range | range of motion in the trunk during walking, in the lateral direction | 6 weeks |
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
55 Years
Criterios de sexo
Todos
- Diagnosis of idiopathic PD from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia with 1 or more of the following - rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive conditions
- Responsive to levodopa
- Hoehn & Yahr stages II-IV
- Age range 55-85 years old
- self-report of one or more falls in past 12 months
- willing and able to attend exercise intervention sessions at OHSU campus, and also refrain from changes in anti-parkinson medications and exercise levels.
- Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD
- no medical condition that precludes exercise
- MoCA ≤ 21 or inability to follow directions
- excessive use of alcohol or recreational drugs
- recent change in medication
- inability to stand and walk for 2 minutes without an assistive device
Universidad de Salud y Ciencia de Oregón237 ensayos clínicos activos para explorarEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Parte responsable del ensayo
Martina Mancini, Investigador principal, Principal Investigator, Oregon Health and Science University
No hay datos de contacto.
1 Sitios del ensayo en 1 países
Oregon
Oregon Health & Science University, Portland, Oregon, 97239, United States