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Neurorehabilitation of Sequence Effect in Parkinson's Disease

Destination Sequence Effect Modifications After a 4-week Rehabilitation Program in Parkinson's Diseases Patients

The sequence effect (SE), defined as a reduction in amplitude of repetitive movements, is a common clinical feature of Parkinson's disease (PD), being a major contributor to freezing of gait (FOG). During walking, SE manifests as a step-by-step reduction in step length when approaching a turn or gait destination (dSE). The investigators studied the effect of a 4-week rehabilitation program on the destination sequence effect in patients affected by Parkinson's disease with and without Freezing of Gait. All subjects were evaluated with inertial gait analysis for dSE recording.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

Gait impairment and freezing of gait (FOG) represent common and disabling symptoms of Parkinson's disease (PD). The antiparkinsonian therapy positively modulates a subset of gait parameters, such as speed of gait and stride length, while its impact on FOG is limited. Growing evidence supports the efficacy of neurorehabilitation in the treatment of PD across all phases of the disease. In the last years, the advent of reliable wearable devices has prompted the widespread study of several parameters of the parkinsonian gait in both clinical and research settings.

The sequence effect (SE), defined as a reduction in amplitude of repetitive movements, is a common clinical feature of several tasks of patients affected by PD, being identifiable in early as well as advanced stages of the disease. During walking, SE manifests as a step-by-step reduction in step length when approaching a turn or gait destination (destination sequence effect - dSE). SE is specifically pronounced in PD patients affected by FOG, and it arises immediately before a FOG episode induced by a turning or a dual-task.

SE may be acutely modulated by several rehabilitative strategies such as split-belt treadmill and reinforcement of visual cues, but not by repetitive transcranial magnetic stimulation (rTMS), antiparkinsonian drugs administration, and attention strategies did not influence the SE, the evidence on the role of neurorehabilitation on gait SE improvement and retention is extremely scarce.

The investigators plan to enroll 43 subjects according to sample size calculation. Patients will be divided into two groups: patients with freezing of gait (FOG) and without FOG. The subjects will be divided into two groups: 1) patients with freezing of gait (PD+FOG), or 2) patients without freezing of gait (PD-FOG). FOG phenotype is defined as: a score between 1 and 4 at either item "2.13 Freezing" or item "3.11 Freezing of gait" of the Unified Parkinson Disease Rating Scale (UPDRS).

All patients will be treated with a standardized 4-week rehabilitation in-hospital program. At hospital admission (T0), patients who fulfill inclusion/exclusion criteria will be tested with instrumental gait analysis and administration of a set of the following clinical scales: rating of PD related motor disability with the Unified Parkinson's Disease Rating Scale - part III (UPDRS-III); rating of functional independence as measured through the Functional Independence Measure (FIM); and rating of dependence in activity of daily living according to Barthel Index.

After that, patients will be treated with 90-minute daily rehabilitative sessions, 6 days a week (Monday through Saturday) for four weeks (passive, active-assisted, and active exercises, isotonic and isometric exercises for the major muscles of the limbs and trunk, cardiovascular warm-up exercises, muscle stretching exercises for functional purposes, balance training exercises, specific motor exercise for hypokinesia, and 45 minutes of overground gait training delivered without devices or cueing). The rehabilitation program will be the same in PD+FOG and PD-FOG groups. At the end of the rehabilitation program (T1), the patients will complete the study procedure with a second instrumental gait analysis evaluation and the administration of the same set of clinical scales. No modifications of the drug regimen were allowed during the study.

The gait analysis will be performed with wearable, wireless, inertial system, secured to the back of the patients between L5 and S1 vertebrae. All subjects will be recorded in the morning (between 9:00 a.m. and 11:00 a.m.) and in the ON condition. The investigators plan to record a walk, at a comfortable pace, of 20 meters. The subjects will stop independently at the end of the 20-meter pathway, clearly marked by a straight line on the ground. Gait assessments with episodes of freezing of gait or pauses will be discrded. For each subject, three optimal performed gait assessments will be recorded. Regarding gait parameters the investigators will record: speed (m/s), cadence (steps/minute), stride length (meter), step length (meter), stride duration (second), single support, double support, swing duration, stance duration (percentage stride distribution). The destination Sequence Effect (dSE) will be computed as a regression slope (β) of step length according to a previously described and validated methodology where step length is plotted against step number. Briefly, the length of the last six steps ahead of the final stride are plotted against the step number, and the linear regression slope (β) will represent a measure of dSE. In addition, the intercept (I) of the regression curve will be used as an indirect measure of gait hypokinesia. For each group, the relationship between gait hypokinesia and sequence effect is expressed by the function of the linear regression as follow: y = β (x) + I.

Tipo de estudio

De observación

Inscripción (Actual)

43

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Pavia, Italia, 27100
        • IRCCS Mondino Foundation

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

Patients affected by Idiopathic Parkinson's disease with and without freezing of gait to be consecutively enroll among those attending the Neurorehabilitation Department of the IRCCS Mondino Foundation (Pavia, Italy)

Descripción

Inclusion Criteria:

  • Idiopathic Parkinson's disease
  • Hoehn and Yahr stage between I and IV
  • Mini-Mental State Examination score above 24.

Exclusion Criteria:

  • Major psychiatric or other neurological conditions,
  • Rheumatological diseases
  • Ophthalmic diseases
  • Orthopedic diseases
  • Ongoing or previous treatment with neuroleptic drugs
  • Patients with deep brain stimulation
  • Any change in dose or regimen of the anti-parkinsonian therapy in the last month before enrolment.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
PD+FOG group
Patients affected by Parkinson's Disease with freezing of gait (PD+FOG group)
All patients will be treated with an in-hospital rehabilitation program focused on the rehabilitation of gait disorder in PD with 90-minute daily sessions, 6 days a week (Monday through Saturday) for four weeks. The rehabilitation treatment includes passive, active-assisted, and active exercises, isotonic and isometric exercises for the major muscles of the limbs and trunk, cardiovascular warm-up exercises, muscle stretching exercises for functional purposes, balance training exercises, specific motor exercise for hypokinesia, and 45 minutes of overground gait training delivered without devices or cueing The rehabilitation program is the same in PD patients with and without FOG.
Otros nombres:
  • Rehabilitación
  • Terapia física
PD-FOG group
Patients affected by Parkinson's Disease without freezing of gait (PD+FOG group)
All patients will be treated with an in-hospital rehabilitation program focused on the rehabilitation of gait disorder in PD with 90-minute daily sessions, 6 days a week (Monday through Saturday) for four weeks. The rehabilitation treatment includes passive, active-assisted, and active exercises, isotonic and isometric exercises for the major muscles of the limbs and trunk, cardiovascular warm-up exercises, muscle stretching exercises for functional purposes, balance training exercises, specific motor exercise for hypokinesia, and 45 minutes of overground gait training delivered without devices or cueing The rehabilitation program is the same in PD patients with and without FOG.
Otros nombres:
  • Rehabilitación
  • Terapia física

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Destination sequence effect (dSE) modifications
Periodo de tiempo: Change from baseline (T0) to four weeks (T1)
Using an inertial gait analysis we will explore the modifications of destination sequence effect in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program
Change from baseline (T0) to four weeks (T1)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Between-group comparison of dSE
Periodo de tiempo: Baseline (T0)
Comparison of destination Sequence Effect in PD patients with FOG vs. PD patients without FOG
Baseline (T0)
Gait hypokinesia modifications
Periodo de tiempo: Change from baseline (T0) to four weeks (T1)
Using an inertial gait analysis we will explore the modifications of intercept "I" in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program
Change from baseline (T0) to four weeks (T1)
Speed modifications
Periodo de tiempo: Change from baseline (T0) to four weeks (T1)
Using an inertial gait analysis we will explore the modifications of speed (m/s) in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program
Change from baseline (T0) to four weeks (T1)
Cadence modifications
Periodo de tiempo: Change from baseline (T0) to four weeks (T1)
Using an inertial gait analysis we will explore the modifications of cadence (steps/min) in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program
Change from baseline (T0) to four weeks (T1)
Stride duration modifications
Periodo de tiempo: Change from baseline (T0) to four weeks (T1)
Using an inertial gait analysis we will explore the modifications of stride duration (s) in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program
Change from baseline (T0) to four weeks (T1)
Stride lenght modifications
Periodo de tiempo: Change from baseline (T0) to four weeks (T1)
Using an inertial gait analysis we will explore the modifications of stride length (m) in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program
Change from baseline (T0) to four weeks (T1)
Stance modifications
Periodo de tiempo: Change from baseline (T0) to four weeks (T1)
Using an inertial gait analysis we will explore the modifications of stance phase (%) in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program
Change from baseline (T0) to four weeks (T1)
Swing modifications
Periodo de tiempo: Change from baseline (T0) to four weeks (T1)
Using an inertial gait analysis we will explore the modifications of Swing phase (%) in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program
Change from baseline (T0) to four weeks (T1)
Double support modifications
Periodo de tiempo: Change from baseline (T0) to four weeks (T1)
Using an inertial gait analysis we will explore the modifications of double support (%) in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program
Change from baseline (T0) to four weeks (T1)
Single support modifications
Periodo de tiempo: Change from baseline (T0) to four weeks (T1)
Using an inertial gait analysis we will explore the modifications of single support (%) in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program
Change from baseline (T0) to four weeks (T1)
Motor disability improvement
Periodo de tiempo: Change from baseline (T0) to four weeks (T1)
We will explore the changes in motor disability as measured by Unified Parkinson Disease Rating Scale - part III (UPDRS-III) in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program
Change from baseline (T0) to four weeks (T1)
Functional Independence improvement
Periodo de tiempo: Change from baseline (T0) to four weeks (T1)
We will explore the changes in functional independence as measured by Functional Independence Measure (FIM) in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program
Change from baseline (T0) to four weeks (T1)
Dependence in activity of daily living improvement
Periodo de tiempo: Change from baseline (T0) to four weeks (T1)
We will explore the changes in dependence in activity of daily living as measured by barthel Index in PD patients with and without freezing of gait treated with a 4-week in-hospital rehabilitation program
Change from baseline (T0) to four weeks (T1)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Roberto De Icco, MD, IRCCS Mondino Foundation, Pavia

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de agosto de 2019

Finalización primaria (Actual)

31 de enero de 2021

Finalización del estudio (Actual)

28 de febrero de 2021

Fechas de registro del estudio

Enviado por primera vez

4 de junio de 2021

Primero enviado que cumplió con los criterios de control de calidad

4 de junio de 2021

Publicado por primera vez (Actual)

10 de junio de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de junio de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

10 de junio de 2021

Última verificación

1 de junio de 2021

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

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