Usability Testing of Affordable Haptic Robots for Stroke Therapy (Theradrive)
3 de septiembre de 2020 actualizado por: University of Pennsylvania
Stroke survivors with hemiplegia will be evaluated by rehabilitation professionals and asked to perform a battery of assessments to test the viability and usability of a force-feedback robot that adapts to each individual subject's performance.
Subsequently, they will be asked to complete post-assessment questionnaires that provide feedback to the researchers on their observations and thoughts about the therapy devices.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
TheraDrive is a low-cost robotic system for post-stroke upper extremity rehabilitation.
The system uses off-the-shelf computer gaming wheels with force feedback to help reduce motor impairment and improve function in the arms of stroke survivors.
Preliminary results from various studies have shown that the original TheraDrive system lacked a robust mechanical linkage which could withstand the forces exerted by patients, lacked a patient-specific adaptive controller to deliver personalized therapy, and was not capable of delivering effective therapy to severely low-functioning patients.
A new low-cost, high-force haptic robot with a single degree of freedom has been developed to address these concerns.
This study has two purposes: first, to test the viability and usability of the new robot system alongside the original TheraDrive system; and second, to test if low-functioning patients benefit, and if so how much, from using force-feedback therapy as opposed to devices with zero impedance.
This will be done by recruiting approximately 36 human subjects.
Exercises will be performed by study subjects and an adaptive controller will monitor patient performance to ensure that exercises are difficult but doable, which is important for maintaining patient motivation.
It is hypothesized that not only will the new system be viable, but that it will provide better robot-assisted therapy to a large variety of patients, especially low-functioning stroke survivors with hemiplegia.
Tipo de estudio
Intervencionista
Inscripción (Actual)
23
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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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19146
- Penn Medicine Rittenhouse
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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 y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Stroke survivors at least 18 years of age with hemiplegia.
- The subject's stroke must have occurred at least 3 months prior to enrollment in the study.
- Low and Moderate functioning stroke survivors as measured by Fugl- Meyer
- Not depressed
- No more than Mild Cognitive Deficit
- Participants must be able to sit upright for 4 hours at a time in Part A of the study; and 2 hours at a time, 3 days a week, for Part B of the study.
- The subject's stroke must have occurred at least 3 months prior to enrollment in the study.
Exclusion Criteria:
- Greater than mild cognitive deficits
- Greater than mild depression. A member of the research team will administer Beck's Depression Inventory (BDI) to each study participant over the phone. If the participant is found to have greater than mild depression, as measured by the BDI, they will not qualify for the study.
- Receiving rehabilitation on the upper limb.
- Received Botox injections within the past 3 months.
- Suffering from contractures (chronic loss of joint motion) or debilitating spasticity in the upper extremity.
- Experiencing greater than mild pain, and/or the PI determines that the participant should no longer continue working with the novel therapy devices, the study will be stopped.
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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Stroke survivors with low and moderate motor deficits
Subjects with low and moderate motor deficits will 1) complete exercises with 2 commercial (joystick and wheel) and the Theradrive haptic robot after pre assessment 2) then experience 12 therapy sessions on the Theradrive haptic robot with Adaptive Feedback.
3) Assessments pre and post therapy.
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Commercial Joystick and Wheels Plus the Haptic TheraDrive Robot will be used.
Haptic Theradrive is a low-cost robotic system for post-stroke upper extremity rehabilitation.
The system uses off-the-shelf computer gaming wheels with force feedback to help reduce motor impairment and improve function in the arms of stroke survivors.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Fugl Meyer
Periodo de tiempo: At 0 weeks
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The primary outcomes are motor control for the upper limb: Subjects completed tasks on scale; Motor scale maximum is 66. minimum is 0. Lower is more impaired.
Higher is less impaired.
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At 0 weeks
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Box and Blocks
Periodo de tiempo: At Session 0. Pre-intervention
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Measures ADL Function.
Completed reach and grasp activities.
Reached for 1 inch cube and placed with impaired arm.
More blocks indicate higher function.
Less blocks lower function
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At Session 0. Pre-intervention
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Tracking Accuracy
Periodo de tiempo: At Session 0
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Tracking accuracy is measured using the normalized root mean square, which is a measure for error in tracking performance with respect to a desired goal.
Root mean squared divided by the maximum error if person does not move.
The higher the decimal the higher the error made.
Lower is better performance.
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At Session 0
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Grip Strength
Periodo de tiempo: pre-intervention
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Grip strength as measured by a dynamometer.
Subjects were asked to squeeze a dynamometer with impaired arm.
Higher forces mean better function
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pre-intervention
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Montreal Cognitive Assessment (MOCA)
Periodo de tiempo: pre-intervention
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A brief 30-question test that takes around 10 to 12 minutes to complete and helps assess people for impairment in cognition domains.
Maximum is 30.
Minimum is 0; Low is <17 is severe cognitive impairment; a score 26 and higher is normal cognition.
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pre-intervention
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Becks Depression Scale
Periodo de tiempo: Pre-intervention
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Measures depression.
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression (Beck, et al., 1961).
Maximum is 63 Total Score_______________Levels of Depression 1-10____________________These ups and downs are considered normal 11-16___________________ Mild mood disturbance 17-20___________________Borderline clinical depression 21-30___________________Moderate depression 31-40___________________Severe depression over 40__________________Extreme depression
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Pre-intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Michelle J Johnson, PhD, Penn Medicine Rittenhouse
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.
Publicaciones Generales
- Ruparel R, Johnson MJ, Strachota E, McGuire J, Tchekanov G. Evaluation of the TheraDrive system for robot/computer assisted motivating rehabilitation after stroke. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:811-4. doi: 10.1109/IEMBS.2009.5332386.
- Johnson MJ, Ramachandran B, Paranjape RP, Kosasih JB. Feasibility study of TheraDrive: a low-cost game-based environment for the delivery of upper arm stroke therapy. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:695-8. doi: 10.1109/IEMBS.2006.259971.
- Theriault A, Nagurka M, Johnson MJ. Design and development of an affordable haptic robot with force-feedback and compliant actuation to improve therapy for patients with severe hemiparesis. IEEE Trans Haptics. 2014 Apr-Jun;7(2):161-74. doi: 10.1109/TOH.2013.51.
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 marzo de 2014
Finalización primaria (Actual)
1 de julio de 2017
Finalización del estudio (Actual)
1 de julio de 2017
Fechas de registro del estudio
Enviado por primera vez
29 de marzo de 2016
Primero enviado que cumplió con los criterios de control de calidad
11 de mayo de 2016
Publicado por primera vez (Estimar)
16 de mayo de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de septiembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
3 de septiembre de 2020
Última verificación
1 de septiembre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 819787
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
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