- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04897256
Movilidad en la vida diaria y caídas en la enfermedad de Parkinson: potencial para la rehabilitación
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Oregon
-
Portland, Oregon, Estados Unidos, 97239
- Oregon Health & Science University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 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 Oregon Health & Science University (OHSU) campus, and also refrain from changes in anti-parkinson medications and exercise levels.
Exclusion Criteria:
- Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD
- no medical condition that precludes exercise
- Montreal Cognitive Assessment (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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: TURN-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. |
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 intervención: No 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Variability in Number of Steps to Complete a Turn
Periodo de tiempo: 6 weeks
|
The coefficient of variation in the number of steps in a turn, averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Falls Efficacy Scale International
Periodo de tiempo: baseline and 6 weeks
|
The difference in the Falls Efficacy Scale, as measured at baseline and 6 weeks. The Falls Efficacy Scale is a 16 item self-administered questionnaire to assess fear of falling. Scores range 16-64 with higher score indicating more fear of falling. |
baseline and 6 weeks
|
|
Prospective Fall Incidence
Periodo de tiempo: 52 weeks
|
Number of prospective falls recorded for 12 months starting from the end of intervention |
52 weeks
|
|
Patient Global Impression of Change
Periodo de tiempo: 6 weeks
|
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. Single score provided at the end of 6 week period. |
6 weeks
|
|
Number of Steps to Complete a Turn
Periodo de tiempo: 6 weeks
|
The number of steps in a turning averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
|
Turn Peak Velocity
Periodo de tiempo: 6 weeks
|
Peak velocity of turns averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
|
Turn Angle Amplitude
Periodo de tiempo: 6 weeks
|
The peak size of turn angles averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
|
Turn Duration
Periodo de tiempo: 6 weeks
|
Time to complete turns averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
|
Variability of Double-support Time
Periodo de tiempo: 6 weeks
|
The coefficient of variation in time of double-support phase, as measured at 6 weeks. |
6 weeks
|
|
Lateral Trunk Range
Periodo de tiempo: 6 weeks
|
The range of motion in the trunk during walking, in the lateral direction, as measured at 6 weeks. |
6 weeks
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Mini-Balance Evaluation Systems Test
Periodo de tiempo: baseline and 6 weeks
|
The change in mini-Balance Evaluation Systems Test, a clinical measure of four balance domains-anticipatory, reactive, sensory, and dynamic gait, as measured at baseline and 6 weeks. Scores range from 0-28 with higher scores indicating worse balance. |
baseline and 6 weeks
|
|
Clinical Global Impression of Change
Periodo de tiempo: 6 weeks
|
Question of clinician's rating of participant mobility. Score range from 1-7 with 1-3 indicating improvement, 4 no change, and 5-7 worsening of mobility. Single score provided at the end of 6 week period. |
6 weeks
|
|
Change in Parkinson's Disease Questionnaire-39
Periodo de tiempo: baseline and 6 weeks
|
The difference in the Parkinson's disease questionnaire-39 (PDQ-39) - a 39 item self-report questionnaire to assess Parkinson's disease specific health related quality in eight domains of quality of life - as measured at baseline and 6 weeks. Each item scores from 0 (never) to 4 (always). Sub-scale scores and a Parkinson's Disease summary index (PDSI; sum of eight subsections/8) representing the global health-related quality of life will be calculated, with higher scores representing worse quality of life |
baseline and 6 weeks
|
|
Change in Unified Parkinson's Disease Rating Scale, Part III
Periodo de tiempo: baseline and 6 weeks
|
Difference in the Unified Parkinson's Disease Rating Scale, Part III (UPDRS-III), as measured at baseline and 6 weeks. The UPDRS-III is a clinical scale to assess severity of motor symptoms in Parkinson's disease. Each item is scored 0 (normal) to 4 (severe) with a score range from 0-132 |
baseline and 6 weeks
|
|
Change in Activities-Specific Balance Confidence Scale
Periodo de tiempo: baseline and 6 weeks
|
The difference in Activities-Specific Balance Confidence (ABC) Scale, as measured at baseline and 6 weeks. The ABC Scale is a 16-item self-report scale that participants rate their confidence in performing daily activities. Score range from 0-100% with 0% meaning no confidence and 100% completely confident |
baseline and 6 weeks
|
|
Stride Velocity
Periodo de tiempo: 6 weeks
|
Stride velocity during straight walking averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
|
Stride Length
Periodo de tiempo: 6 weeks
|
Stride length during straight walking averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
|
Cadence
Periodo de tiempo: 6 weeks
|
The number of straight walking steps taken per minute averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
|
Double Support Time
Periodo de tiempo: 6 weeks
|
The amount of time both feet were on the ground together during straight walking averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
|
Angle of Foot at Heel Strike
Periodo de tiempo: 6 weeks
|
The angle between the foot and the ground at heel strike during straight walking averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
|
Variability of Angle of Foot at Heel Strike
Periodo de tiempo: 6 weeks
|
Coefficient of variation of the angle between the foot and the ground at heel strike during straight walking averaged from daily monitoring, as measured at 6 weeks. |
6 weeks
|
|
Number of Turns Per Hour
Periodo de tiempo: 6 weeks
|
The average number of turns per hour measured during daily monitoring at 6 weeks. |
6 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Fay Horak, PhD, PT, Oregon Health and Science University
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R01HD100383 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Upon reasonable request, we can share de-identified data related to study outcomes measures.
Marco de tiempo para compartir IPD
Data would be available 6 months after the end of data collection. Data will be stored in our laboratory data repository and so will be available indefinitely.
Criterios de acceso compartido de IPD
Data will not be stored on a public website, however researchers may contact us for access to the data. We will send data electronically via a secure server.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .