Targeting Balance Confidence to Increase Community Integration in Users of Prostheses
31 de mayo de 2022 actualizado por: Noah Rosenblatt, Rosalind Franklin University of Medicine and Science
Targeting Balance Confidence as a Strategy to Increase Integration and Improve Outcomes in Users of Lower-Limb Prostheses
Low balance confidence occurs when an individual perceives they have limited ability to maintain their balance while performing a specific task of daily living.
It is a prevalent problem in lower limb prosthesis users and is a strong predictor of prosthesis use and community participation.
Balance confidence is not necessarily related to functional abilities.
It is possible to improve functional ability as a result of rehabilitation, without concurrently improving balance confidence.
Interventions to address low balance confidence may need to target both functional abilities as well as beliefs regarding these abilities.
The purpose of this study is to test whether, for users of lower limb prostheses, an intervention combining physical therapy exercise to improve function with cognitive behavioral therapy to address fears and thoughts associated with low confidence can improve balance confidence and promote community participation.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Lower limb prosthesis users, with self-reported low balance confidence complete baseline gait analysis and balance testing, as well as a series of validated self-reported outcome scales addressing balance confidence, quality of life, and community integration.
Participants are then provided a step activity monitor (SAM) and a global position sensing (GPS) tracker to be worn for one week, the data from which is linked and used to objectively quantify baseline community participation.
At the conclusion of the one week, participants are randomized to one of two groups, each of which will last for 8 weeks.
At the conclusion of the eight weeks, participants repeat baseline assessments and are again provided a SAM and GPS tracker to wear for one week.
Baseline measures and activity monitoring occur again 8 and 16 weeks thereafter.
Tipo de estudio
Intervencionista
Inscripción (Actual)
22
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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Illinois
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North Chicago, Illinois, Estados Unidos, 60064
- Captain James A. Lovell Federal Health Care Center
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North Chicago, Illinois, Estados Unidos, 60064
- Rosalind Franklin University of Medicine and Science
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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:
- age ≥18 years
- unilateral lower limb amputation without serious complications
- at least 6 months experience using a definitive lower limb prosthesis
- Activity Specific Balance Confidence (ABC) scale score≤80
- self-reported concern about balance that limit activities
Exclusion Criteria:
- active wounds on weight bearing surfaces
- inability to perform the protocol without an assistive device
- currently seeing a physical therapist for any reason
- history of neurodegenerative disease
- history of stroke
- ill-fitting or ill-functioning prosthesis (to be verified by research prosthetist during screening)
- prohibited by primary care physician or research physician to participate in mild exercise
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 paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Exercise Group A
Weekly exercise sessions with physical therapist and psychologist
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Eight weekly sessions integrating techniques from physical therapy and cognitive behavioral therapy.
At the start of each session participants play virtual reality games that target balance and functional gait and then discuss their balance confidence and activity avoidance behaviors with a behavioural counselor.
Weekly homework assignments ask participants to report on thoughts causing them to avoid activities and to slowly engage in activities that present increasing levels of fear.
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Comparador de placebos: Exercise Group B
Home-based exercises
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Stretching and other exercises are safely taught by physical therapist and then practiced at home following a provided schedule.
Participants receive periodic calls to discuss progress.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Community integration
Periodo de tiempo: 24 weeks
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number of steps taken outside of the home
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24 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Social Functioning scale from the 36-item Short Form Health Survey
Periodo de tiempo: 24 weeks
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The scale measures the extent to which physical and emotional problems interfere with social activities on a scale of 0-100 with higher scores indicating less interference
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24 weeks
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Role Limitation due to Emotional Problems scale from the Short Form Health Survey (SF36)
Periodo de tiempo: 24 weeks
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The scale measures the extent to which emotional problems interfere with work and daily activities on a scale of 0-100 with higher scores indicating less interference
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24 weeks
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Extent of Participation scale from the Measure of Community Reintegration of Servicemembers
Periodo de tiempo: 24 weeks
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The scale measures community participation in terms of how often an individual engages in certain activities on a score of 10-70 with higher scores indicating greater participation
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24 weeks
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Perceived Limitation scale from the Measure of Community Reintegration of Servicemembers
Periodo de tiempo: 24 weeks
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The scale measures self-perceived limitations in community participation n a score of 10-70 with higher scores indicating less limitation
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24 weeks
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Frenchay Activity Index
Periodo de tiempo: 24 weeks
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This is a behavioral scale that primarily measures social participation, as well as daily activities on a score of 0-45 with higher scores indicating greater social activity.
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24 weeks
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Change from baseline in Activity-specific balance confidence scale following the intervention
Periodo de tiempo: 8 weeks
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The ABC scale measures balance confidence on a scale of 0-100 with higher values indicating greater confidence
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8 weeks
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Activity-specific balance confidence scale
Periodo de tiempo: 24 weeks
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The ABC scale measures balance confidence on a scale of 0-100 with higher values indicating greater confidence.
Measurement at this time point will indicate the lasting impact of the intervention on balance confidence
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24 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Well-being scale from the Prosthetic Evaluation Questionnaire
Periodo de tiempo: 24 weeks
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The scale measures overall quality of life on a score of 0-100 with higher scores indicating increased quality of life.
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24 weeks
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Change from baseline in Berg Balance Scale
Periodo de tiempo: 8 wks
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This scale measures measures balance function by assessing the performance of functional tasks.
It is scored from 0-45 with high scores indicating better balance.
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8 wks
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Change from baseline on L-test performance
Periodo de tiempo: 8 wks
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Participants rise from a chair without armrests, walk 3m, turn right, walk 7m, turn around and trace their path back to the start.
Time to complete the task is noted.
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8 wks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
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)
5 de abril de 2018
Finalización primaria (Actual)
1 de mayo de 2022
Finalización del estudio (Actual)
1 de mayo de 2022
Fechas de registro del estudio
Enviado por primera vez
10 de enero de 2018
Primero enviado que cumplió con los criterios de control de calidad
18 de enero de 2018
Publicado por primera vez (Actual)
26 de enero de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de junio de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
31 de mayo de 2022
Última verificación
1 de mayo de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- OP160044
- W81XWH-17-1-0697 (Otro número de subvención/financiamiento: Department of Defense)
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
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