- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07735195
Tyrannosaurus Flex: Finding the "Fair-ly Normal" Grip
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Corey McGee, PhD, MS, OTR/L, CHT, FAOTA
- Puhelinnumero: 612-626-5645
- Sähköposti: mcge0062@umn.edu
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Perustiede
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: 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.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Collection of normative grip strength data using the Dinomometer
Aikaikkuna: During a single study visit lasting approximately 10-15 minutes
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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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Grip strength variability across demographic subgroups
Aikaikkuna: During a single study visit lasting approximately 10-15 minutes
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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.
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During a single study visit lasting approximately 10-15 minutes
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Corey McGee, PhD, MS, OTR/L, CHT, FAOTA, University of Minnesota
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- STUDY00028771
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