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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Corey McGee, PhD, MS, OTR/L, CHT, FAOTA
- Phone Number: 612-626-5645
- Email: mcge0062@umn.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Collection of normative grip strength data using the Dinomometer
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Grip strength variability across demographic subgroups
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Corey McGee, PhD, MS, OTR/L, CHT, FAOTA, University of Minnesota
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00028771
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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