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- Ensayo clínico NCT03561155
Robot-assisted Arm Training in Multiple Sclerosis (RAMSES)
18 de junio de 2018 actualizado por: Nicola Smania, MD, Clinical Professor, Universita di Verona
Effects of High-intensity Robot-assisted Training in Hand Function Recovery and ADL Independence in Individuals With Multiple Sclerosis: a Randomized Controlled Single-blinded Trial
The upper limb (UL) plays an important role in the daily functioning of patients with Multiple Sclerosis (MS) and negatively influences their quality of life.
Effective arm-hand training programs are needed.
Various robotic systems have been developed for UL rehabilitation, mainly used in patients with stroke.
Preliminary work in MS has focused on proximal sections of the arm.
No study has evaluated the use of robotics for improving manual dexterity and their effects on cortical activity.
The results of this research project could be relevant for the advancement of knowledge about UL functional recovery in individuals with MS and to determine the pattern of muscle activation underlying functional recovery.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Studies regarding the effectiveness of conventional and robot-based upper limb (UL) rehabilitation in individuals with MS is very limited.In the last 15 years, conventional rehabilitation of the UL in patients with neurological disorders has been enriched by the development of robots as they can provide high-intensity, repetitive, interactive and task-specific exercises.They are increasingly used in rehabilitation after stroke, therefore may also be good candidates for neuromotor rehabilitation of patients with MS.
Furthermore, these devices can provide various feedbacks that can guide patients during the sensorimotor training and allow quantitative measurement of motor performance during training.One of these devices is the Amadeo®, a modern, mechatronic end-effector robotic device designed to improve sensorimotor functions in patients with restricted movement in individual fingers or in the entire hand.Another important issue concerns cortical plasticity, which plays a fundamental role in motor learning and neurorehabilitation.To date, the specific mechanisms leading to UL recovery after neurological rehabilitation are still unclear.The development of new EEG instruments allows brain activity to be tested under specific rehabilitation tasks contributes to give new insight in the dynamics of cortical networks reorganization promoted by rehabilitation.The main aim of the study is to perform a single blind RCT on 60 outpatients with MS (age:18-65 years;EDSS<8) in order to compare the efficacy of high-intensity robot-assisted training with conventional treatment on sensorimotor hand recovery, disability in ADLs and QoL.The secondary aim is to explore the underlying neuronal mechanisms of UL recovery by using EEG investigations and innovative robotic equipment.
10 controls (age 18-65 yrs) will undergo one session of the same Video-EEG acquisition to collect normative data to compare with data collected on patients.Each participant will receive 40-minute sessions over an 8 week period (3 days/week).
Each session will consist of 30 minutes of hand training and 10 minutes of passive upper limbs mobilization.The experimental group will receive robot-assisted therapy by Amadeo.The control group will receive conventional rehabilitation.Before treatment, immediately after treatment, 1 month after treatment patients will be evaluated with a comprehensive protocol of all ICF domains as well as acquisition by Video-EEG acquisition combined with Amadeo® robotic training device.Primary outcome measures:Fugl-Meyer Assessment Motor Scale.Secondary measures: UL electromyographic analysis,Tremor Severity Scale, Nine Hole Peg Test, Amadeo® hand muscle strength (Newton), Motricity Index, Visual anolgue Scale for tiredness and fatigue; TEMPA, Motor Activity Log, Action Research Arm test, Multiple Sclerosis Quality of Life-54 and the assessment of Life Habits.
Parametric tests and nonparametric tests will be performed according to variable distribution (p<.05)
Tipo de estudio
Intervencionista
Inscripción (Actual)
60
Fase
- No aplica
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
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Verona, Italia, 37134
- UOC Neurorehabilitation
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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 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Age: 18-65 years
- EDSS score<8
- Mini Mental State Evaluation (MMSE) score>24
- Ashworth Scale Score<2 evaluated at the elbow, wrist and fingers
- Nine Hole Peg Test (NHPT) score >30 sec.
Exclusion Criteria:
- Disease recurrence that worsened significantly during the 3 months prior to recruitment
- Medical therapy not well defined
- Musculoskeletal impairments or excessive pain in any joint that could limit participation in an exercise program
- Severe visual dysfunction
- Performance of any type of rehabilitation treatment in the month prior to recruitment
- Other concomitant neurological or orthopaedic diseases involving the UL and interfering with their function
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
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Robot assisted treatment
The experimental group (EG) will undergo a robot-assisted arm training using Amadeo® (Tyromotion-Austria).
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The protocol will consist of exercises as follows: passive modality , passive/plus modality , assisted therapy and Balloon.
Otros nombres:
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Comparador activo: Conventional treatment
The conventional group (CG) will undergo robot unassisted treatment (Conventional treatment).
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The protocol will consist of exercises as follow: upper limb mobilization, facilitation of movements and active tasks. The exercises will be focused on improving muscle strength, finger extension and flexion and motor control |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Action Research Arm test
Periodo de tiempo: Up to 6 weeks
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Assesses upper limb functioning using observational methods
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Up to 6 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Fugl-Meyer Assessment Motor Scale - Arm Section
Periodo de tiempo: Up to 6 weeks
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Evaluates and measures recovery in post-stroke hemiplegic patients
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Up to 6 weeks
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Motor Activity Log
Periodo de tiempo: Up to 6 weeks
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Semi-structured interview to assess arm function.
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Up to 6 weeks
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Tremor Severity Scale
Periodo de tiempo: Up to 6 weeks
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A clinical rating scale which measured the severity of tremor
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Up to 6 weeks
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Nine Hole Peg Test
Periodo de tiempo: Up to 6 weeks
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Measures finger dexterity
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Up to 6 weeks
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Motricity Index
Periodo de tiempo: Up to 6 weeks
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Measures of strength in upper limb
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Up to 6 weeks
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Amadeo® hand muscle strength (Newton)
Periodo de tiempo: Up to 6 weeks
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Measures of muscle strenght using the robotic device
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Up to 6 weeks
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Visual anolgue Scale for tiredness and fatigue
Periodo de tiempo: Up to 6 weeks
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Measures of tirediness and fatigue on a 10-point likert scale
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Up to 6 weeks
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Multiple Sclerosis Quality of Life-54
Periodo de tiempo: Up to 6 weeks
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Measures of a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument.
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Up to 6 weeks
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Assessment of Life Habits
Periodo de tiempo: Up to 6 weeks
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Assesses participants on 77 life habits from daily activities to social participation across 12 domains.
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Up to 6 weeks
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UL electromyographic analysis of muscle activation
Periodo de tiempo: Up to 6 weeks
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Instrumental assessment of muscle activity during a reaching task
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Up to 6 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Nicola Smania, Professor, Universita di Verona
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 noviembre de 2014
Finalización primaria (Actual)
1 de septiembre de 2017
Finalización del estudio (Actual)
1 de mayo de 2018
Fechas de registro del estudio
Enviado por primera vez
23 de mayo de 2018
Primero enviado que cumplió con los criterios de control de calidad
18 de junio de 2018
Publicado por primera vez (Actual)
19 de junio de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de junio de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
18 de junio de 2018
Última verificación
1 de junio de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FISM 14/14/F14
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
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