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Interactive Telehealth for Wheelchair Users

10 de febrero de 2020 actualizado por: Sara Mulroy, Rancho Research Institute, Inc.

Interactive Telehealth and Auto-Biofeedback Sensor System for Individuals Who Use a Wheelchair: Phase II

During typical daily activity, people with established spinal cord injury perform significantly fewer pressure-relief maneuvers than the recommended frequency while overestimating their adherence on recall surveys of pressure relief activity. The rate of pressure ulcer recurrence in individuals with a prior ulcer is 44% in those with surgical repair and as high as 75% in those with non-surgical healing indicating that increased attention to pressure relief is critical for these individuals.This study will evaluate the efficacy of a wheelchair sensor and app-based biofeedback for establishing healthy self-management behaviors (pressure relief maneuvers and daily physical activity). Investigators will enroll 50 participants with paraplegia from spinal cord injury who use a manual wheelchair for mobility and have a history of pressure ulcer that has healed or is six months post-surgical repair. Participants will be randomized into one of two groups: an intervention group that will receive an education intervention and the proposed technology to be used for one year, and a control group that will receive only the education intervention. The primary outcome will be pressure ulcer occurrence over one year. Investigators hypothesize that participants receiving the intervention of biofeedback on their pressure relief activity will have a lower recurrence of pressure ulcer than the education only control group. Secondary outcomes include depressive symptoms, self-efficacy, participation and satisfaction with life. Investigators hypothesize that increasing physical activity will reduce depressive symptoms and improve participation and satisfaction with life.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

Purpose: The purpose of this study is to evaluate the efficacy of an interactive tele-health monitoring and biofeedback system to establish healthy behaviors and promote self-management of pressure relief maneuvers and physical activity.

Procedures and Course of Study:

Baseline 50 participants will be enrolled. At study entry participants will complete four baseline questionnaires and have a Nurse Practitioner or Physician's Assistant inspect their ischial skin to ensure that their prior ulcer is fully healed. A pressure-sensing mat (PRESS) will be placed under their wheelchair cushion, and a wheelchair propulsion motion sensor (WAMS) will be placed on the rear wheel of their wheelchair. The PRESS and WAMS sensors will record participants' pressure relief and wheelchair propulsion activity for the next two weeks.

Intervention:

Participants will then return to the clinic and the study physical therapist will provide all participants with education on importance of pressure relief maneuvers and physical activity for health as well as training in the 3 styles of pressure relief (forward and side leans, depression raise) and shoulder strengthening exercises to protect against shoulder impingement and pain with increased pressure relief and wheelchair propulsion activity. The study physical therapist will then assist all participants in setting goals to increase pressure relief frequency and/or duration and wheelchair propulsion pushes for the future based on their baseline activity. Participants will be randomized into one of two groups: feedback and no feedback. In both groups pressure relief and wheelchair propulsion activity will be recorded by the PRESS and WAMS sensors for the 12 months. Those participants in the no-feedback group will have the feedback features of the system disabled. Those participants in the feedback group will receive instant visual feedback on pressure relief duration and daily summary charts for both pressure relief and wheelchair propulsion activities.

Follow-up:

Every month following the intervention for 12 months, a physical therapist will contact participants by phone to inquire whether their ischial skin integrity has changed and whether they have developed a pressure ulcer. Additionally, all participants will return to the clinic at 3, 6, 9, and 12 months after the intervention and a nurse practitioner will examine their ischial skin and review their medical records to determine if a pressure ulcer has developed. Participants will repeat the 4 questionnaires from the baseline evaluation at each follow-up visit. At the 12 month follow-up visit, participants will return the sensor equipment.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

50

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

  • Estados Unidos
    • California
      • Downey, California, Estados Unidos, 90242
        • Rancho Los Amigos National Rehabilitaiton Center

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:

  • paraplegia from Spinal Cord Injury
  • a history of pressure ulcer that has healed or 6 months post surgical repair
  • use a manual wheelchair for mobility
  • able to perform pressure relief maneuvers independently

Exclusion Criteria:

  • unable/unwilling to return to clinic for follow-up visits

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: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: An interactive telehealth monitoring and biofeedback system
Participants in this group will receive feedback of pressure relief maneuvers and wheelchair propulsion activity. Feedback for pressure relief will include information during the activity to identify adequate duration and magnitude of pressure relief activity, reminders of when the next pressure relief is due, and daily aggregate information regarding the number of successful pressure relief maneuvers performed.
Dispositivo: An interactive telehealth monitoring and biofeedback system
A pressure sensitive mat located under the user's wheelchair seat cushion and a wheelchair propulsion monitoring device attached to the chair which are interfaced with a phone App based user interface to provide feed back to promote physical activity and pressure relief maneuver performance among wheelchair users.
Comparador falso: Education Control
Participants will receive education on the importance and recommended frequency of pressure relief maneuver for prevention of pressure ulcer/injury and on the importance and recommended amounts of physical activity for health.
Conductual: Education Control
Participants will receive education on importance of pressure relief maneuvers and physical activity and the recommended amounts of each for prevention of pressure ulcer/injury and for physical health.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Recurrence of Pressure Ulcer
Periodo de tiempo: Any time during the one year active phase of the study intervention
Any stage of Pressure Ulcer/Injury identified in the ischial region
Any time during the one year active phase of the study intervention
Change in mean number of cycles of self-propulsion per day from Baseline
Periodo de tiempo: The four weeks preceding the 12 month assessments
The increase or decrease in number of cycles of self-propulsion per day over the 4 weeks preceding the 12 month assessment
The four weeks preceding the 12 month assessments
Change in mean number of pressure relief maneuvers per day from Baseline
Periodo de tiempo: The four weeks preceding the 12 month assessments
The increase or decrease in mean number of pressure relief maneuvers per day over the 4 weeks preceding the 12 month assessment from Baseline
The four weeks preceding the 12 month assessments
Time to Recurrence of Pressure Ulcer
Periodo de tiempo: Any time during the one year active phase of the study intervention
The number of days from study entry to identification of recurrence of Pressure Ulcer/Injury
Any time during the one year active phase of the study intervention

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Patient Health Questionnaire-9 score
Periodo de tiempo: 12 months
Change in Questionnaire scores measuring depressive symptoms at 12 month assessment from baseline score
12 months
Change in University of Washington Self Efficacy Short Form
Periodo de tiempo: 12 months
Change in scores on Questionnaire measuring self-efficacy at 12 month assessment from baseline score
12 months
Change in Reintegration to Normal Living Index
Periodo de tiempo: 12 months
Change score on Questionnaire measuring participation at 12 month assessment from baseline score
12 months
Change in Satisfaction with Life Scale
Periodo de tiempo: 12 months
Change in score on Questionnaire measuring satisfaction with life at 12 month assessment from baseline score
12 months

Colaboradores e Investigadores

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

Patrocinador

Rancho Research Institute, Inc.

Colaboradores

National Institute on Aging (NIA)
BioSensics

Investigadores

  • Investigador principal: Sara Mulroy, PhD, PT, Rancho Los Amigos National Rehab Ce

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 (Anticipado)

1 de marzo de 2020

Finalización primaria (Anticipado)

1 de abril de 2021

Finalización del estudio (Anticipado)

1 de enero de 2022

Fechas de registro del estudio

Enviado por primera vez

7 de febrero de 2020

Primero enviado que cumplió con los criterios de control de calidad

10 de febrero de 2020

Publicado por primera vez (Actual)

12 de febrero de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de febrero de 2020

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

10 de febrero de 2020

Última verificación

1 de febrero de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 5R44AG059275-04 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

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.

Sí

producto fabricado y exportado desde los EE. UU.

No

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