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Tyrannosaurus Flex: Finding the "Fair-ly Normal" Grip

9 de septiembre de 2026 actualizado por: University of Minnesota

The purpose of this study is to evaluate the performance of the Dinomometer and establish normative data to inform clinical standards and benchmarks for therapeutic practice.

This is a cross-sectional study designed to collect normative grip strength data from a large sample of the general population in Minnesota. Participants will primarily be recruited from attendees of the Minnesota State Fair. Grip strength will be measured using the Dinomometer, a non-invasive handheld grip strength measurement device.

The study should take approximately 10-15 minutes to complete for each participant including enrollment and completion of study procedures. Follow-up is not required.

Descripción general del estudio

Estado

Aún no reclutando

Intervención / Tratamiento

Descripción detallada

This is a cross-sectional study designed to collect normative grip strength data from a large sample of the general population in Minnesota. Participants will be primarily recruited from attendees of the Minnesota State Fair, a community event that draws a broad cross-section of individuals across age, sex, height and weight, providing an opportunity to collect normative data that is representative of the general population. The goal of this study is to establish reference values to inform clinical benchmarks for therapeutic use of the Dinomometer.

A designated research booth will be set up at the Minnesota State Fair with signage inviting interested fairgoers to participate in the study. A trained research team member will provide interested participants with a brief explanation of the study. Written informed consent will then be obtained from a parent or guardian on behalf of minor participants, with assent obtained from children as appropriate.

Following consent, the participant will be directed to a trained research team member who will collect demographic information including sex, age, race, ethnicity, county of residence, height, weight, and hand circumference and will log this information into a pre-prepared case report form administered via iPad. No personal identifiers such as names will be collected.

The participant will then be seated comfortably in a chair with the arm adducted and the elbow gently positioned at a 90-degree angle if possible. The research team member will record whether this position was achieved and maintained. Grip strength will be measured using the Dinomometer, a non-invasive handheld grip strength measurement device. Grip strength will be measured on each hand, with short rest breaks and alternation between hands to mitigate the effects of fatigue. Hand size will be measured by taking a circumferential measurement in centimeters of each hand using a standard plasticized dressmaker's tape laid across the distal palmar crease.

The following data will be collected from each participant: age, sex, height, weight, race, ethnicity, county of residence, hand size, hand dominance, grip strength measurements, and whether the standard testing position was achieved and maintained. All data will be recorded in the case report form on an iPad. The Dinomometer is the only device required for participation in this study. It is a non-invasive measurement tool and no drugs or additional investigational agents are required for participation.

The study should take approximately 10-15 minutes to complete for each participant including enrollment and completion of study procedures. Follow-up is not required.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

600

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.

Estudio Contacto

  • Nombre: Corey McGee, PhD, MS, OTR/L, CHT, FAOTA
  • Número de teléfono: 612-626-5645
  • Correo electrónico: mcge0062@umn.edu

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

  • Niño

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  • Children between the ages of 2-12 year old who demonstrate participation interest and provide informed consent and assent (when appropriate).

Exclusion Criteria:

  • Presence of a known musculoskeletal, neurological, or neuromuscular condition affecting upper limb strength or function (including, but not limited to, cerebral palsy, brachial plexus injury, muscular dystrophy, etc.)
  • Diagnosis of a systemic condition affecting the musculoskeletal or nervous system
  • Previous hand, wrist, or upper limb surgery
  • History of hand, wrist, or upper limb trauma
  • Current pain in either hand or upper limb
  • Persons unable to follow standardized commands when presented to them in English

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: Ciencia básica
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Dinomometer Grip Strength Assessment
Participants will complete grip strength measurements using the Dinomometer, a non-invasive handheld grip strength measurement device. Grip strength will be measured on each hand, with short rest breaks and alternation between hands to mitigate the effects of fatigue.
The investigational device being evaluated in this study is the Dinomometer, a handheld grip strength measurement device designed for use in pediatric populations. The Dinomometer will be used to collect grip strength measurements from participants at the Minnesota State Fair. No drugs, biologics, or additional investigational agents are involved in this study.
Otros nombres:
  • Handheld grip strength measurement device

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Collection of normative grip strength data using the Dinomometer
Periodo de tiempo: During a single study visit lasting approximately 10-15 minutes
The primary outcome is the collection of normative grip strength data from a large sample of the general population in Minnesota using the Dinomometer. These data will be used to establish reference values and benchmarks to inform clinical interpretation of Dinomometer measurements in therapeutic settings.
During a single study visit lasting approximately 10-15 minutes

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Grip strength variability across demographic subgroups
Periodo de tiempo: During a single study visit lasting approximately 10-15 minutes
Secondary outcomes include the characterization of grip strength variability across demographic subgroups, including age, sex, height and weight. These data will inform the development of stratified normative reference values to support clinician decision-making across a range of patient populations.
During a single study visit lasting approximately 10-15 minutes

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Corey McGee, PhD, MS, OTR/L, CHT, FAOTA, University of Minnesota

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 (Estimado)

6 de septiembre de 2026

Finalización primaria (Estimado)

31 de agosto de 2028

Finalización del estudio (Estimado)

31 de agosto de 2028

Fechas de registro del estudio

Enviado por primera vez

20 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

24 de julio de 2026

Publicado por primera vez (Actual)

29 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de septiembre de 2026

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

9 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

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

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. .

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