- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03326817
A Soft Robotics Approach Towards Finger Joint Deformities in Rheumatic Diseases
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The aim is to investigate the effect of soft robotic gloves in providing continuous passive motion of the fingers (finger flexion and extension) of degenerative arthritis patients, for the purpose of providing pain relief and alleviating stiffness at the finger joints. Specifically, we intend to 1) observe the changes in range of motion of the fingers using the Total Active Motion (TAM) measure; 2) observe the changes in grip strength and pinch strength; and 3) record changes in the patients' perception of performance in activities of daily living using the Canadian Occupational Performance Measure (COPM).
The hypothesis is that a soft robotics approach in providing continuous passive motion of the finger joints of degenerative arthritis patients can reduce pain, maintain mobility and flexibility of the joints, and to improve hand function. The soft robotics approach and the standard hand therapy is better than the standard hand therapy alone.
The proposed soft robotic glove is capable of providing continuous passive motion (flexion and extension) of the fingers, and in addition, it is also designed to be portable and easy to operate, with minimal supervision. It is aimed at the home therapy of degenerative arthritis patients. In this study, by using the soft robotic glove and in observing changes in finger range of motion, grip and pinch strength, as well as perception of performance in daily activities. This is important in establishing this device as a viable means to ultimately slow down the progression of degenerative arthritis, and to significantly improve the patients' abilities in carrying out activities of daily living, which had been impaired by degenerative arthritis.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Singapore, Singapur, 119074
- National University Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Aged 30-90 years regardless of race
- Osteoarthritis of the hand (Consistent with ACR criteria 1990)
- Ability to pay attention and maintain supported sitting for 45 mins continuously
- Able to give own consent
- Able to comprehend and follow commands (Abbreviated Mental Test >= 7)
Exclusion Criteria:
- Inflammatory arthritis (e.g. rheumatoid arthritis), trigger fingers, carpal tunnel syndrome (by symptoms), finger contractures
- Recent steroid injections in the wrist/hand joints within the past 3 months
- Anti-inflammatory drugs (e.g. non-steroidal anti-inflammatory drugs or oral steroid) in the past 1 month
- Old stroke and/or spasticity affecting the upper limbs
- Epilepsy for the last 6 months as of the date of recruitment
- Poor skin conditions which would hamper donning robotic gloves
- Pregnancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Viabilidad del dispositivo
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Control Group
This group will receive standard care.
|
Patients receive standard care
|
Experimental: Soft Robotic Glove Group
This group will receive standard care and soft robotic therapy (continuous passive motion device developed by National University of Singapore).
|
This group will receive standard care and soft robotic therapy (continuous passive motion device developed by National University of Singapore).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in fingers' Total Active Motion
Periodo de tiempo: Week 1 baseline assessment and Week 11 post intervention assessment
|
Measure hand range of motion in which the sum of the extension at the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints is subtracted from the total achievable flexion of the same joints.
Unit: Degree
|
Week 1 baseline assessment and Week 11 post intervention assessment
|
Change in grip and pinch strength
Periodo de tiempo: Week 1 baseline assessment and Week 11 post intervention assessment
|
Measure hand strength.
Unit: g/kg
|
Week 1 baseline assessment and Week 11 post intervention assessment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in patient's Canadian Occupational Performance Measure
Periodo de tiempo: Week 1 baseline assessment and Week 11 post intervention assessment.
|
Identify issues of personal importance to the patient and to detect changes in a patient's self-perception of occupational performance over time.
|
Week 1 baseline assessment and Week 11 post intervention assessment.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- Salter RB, Hamilton HW, Wedge JH, Tile M, Torode IP, O'Driscoll SW, Murnaghan JJ, Saringer JH. Clinical application of basic research on continuous passive motion for disorders and injuries of synovial joints: a preliminary report of a feasibility study. J Orthop Res. 1984;1(3):325-42. doi: 10.1002/jor.1100010313.
- Kitay GS, Koren MJ, Helfet DL, Parides MK, Markenson JA. Efficacy of combined local mechanical vibrations, continuous passive motion and thermotherapy in the management of osteoarthritis of the knee. Osteoarthritis Cartilage. 2009 Oct;17(10):1269-74. doi: 10.1016/j.joca.2009.04.015. Epub 2009 May 4.
- Kjeken I, Dagfinrud H, Slatkowsky-Christensen B, Mowinckel P, Uhlig T, Kvien TK, Finset A. Activity limitations and participation restrictions in women with hand osteoarthritis: patients' descriptions and associations between dimensions of functioning. Ann Rheum Dis. 2005 Nov;64(11):1633-8. doi: 10.1136/ard.2004.034900. Epub 2005 Apr 13.
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2017/00386
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .
Ensayos clínicos sobre Control Group
-
Joslin Diabetes CenterBrigham and Women's HospitalTerminadoObesidad | Diabetes mellitus tipo 2Estados Unidos
-
University of LisbonAssociacao Protectora dos Diabeticos de PortugalTerminado
-
Johns Hopkins Bloomberg School of Public HealthNative American Research Centers for Health (NARCH)TerminadoSintomas depresivos | Uso de sustanciasEstados Unidos
-
Arizona Oncology ServicesDesconocidoCáncer de mama localizado | Cáncer de próstata localizado | Pacientes que reciben radioterapia de haz externoEstados Unidos
-
University of TennesseeNational Cancer Institute (NCI); Regional One HealthReclutamientoPérdida de peso | Sobrepeso y Obesidad | Comportamiento, SaludEstados Unidos
-
Boston Children's HospitalTerminadoEstrés Psicológico | Problema de aculturaciónEstados Unidos
-
University of Sao Paulo General HospitalTRB ChemedicaTerminadoOsteoartritis | Osteoartritis de rodillaBrasil
-
Amsterdam UMC, location VUmcRed Cross Hospital BeverwijkTerminadoCicatriz Hipertrófica | QueloidePaíses Bajos
-
Aydin Adnan Menderes UniversityAún no reclutando
-
Aydin Adnan Menderes UniversityAún no reclutandoEducación | Estudiantes de EnfermeríaPavo