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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Corey McGee, PhD, MS, OTR/L, CHT, FAOTA
- 電話番号:612-626-5645
- メール:mcge0062@umn.edu
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:基礎科学
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的: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.
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Collection of normative grip strength data using the Dinomometer
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Grip strength variability across demographic subgroups
時間枠: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.
|
During a single study visit lasting approximately 10-15 minutes
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Corey McGee, PhD, MS, OTR/L, CHT, FAOTA、University of Minnesota
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- STUDY00028771
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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