CDE Detailed Report
Disease: Myotonic Muscular Dystrophy
Subdomain Name: Muscle Strength Testing
CRF: Grip Strength Fatigue
Displaying 1 - 12 of 12
Subdomain Name: Muscle Strength Testing
CRF: Grip Strength Fatigue
Displaying 1 - 12 of 12
| CDE ID | CDE Name | Variable Name | Definition | Short Description | Question Text | Permissible Values | Description | Data Type | Disease Specific Instructions | Disease Specific Reference | Population | Classification (e.g., Core) | Version Number | Version Date | CRF Name (CRF Module / Guidance) | Subdomain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | External Id Loinc | External Id Snomed | External Id caDSR | External Id CDISC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C02411 | Laterality type | LatTyp | Laterality type relative to the anatomic site of the body examined or affected | Laterality type relative to the anatomic site of the body examined or affected | Left or Right Grip Strength | Left;Right | Left;Right | Alphanumeric |
Record the grip strength results for each hand side |
Shefner J, Cedarbaum JM, Cudkowicz ME, Maragakis N, Lee J, Jones D, Watson ML, Mahoney K, Chen M, Saikali K, Mao J, Russell AJ, Hansen RL, Malik F, Wolff AA; Neals/Cytokinetics Study Team. Safety, tolerability and pharmacodynamics of a skeletal muscle activator in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2012;13(5):430–438. | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Grip Strength Fatigue | Muscle Strength Testing | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C10171 | Trial number | TrialNum | The number representing the sequence for any repeated measure test or assessment when it is performed multiple times | The number representing the sequence for any repeated measure test or assessment when it is performed multiple times | Trial | Trial 1;Trial 2;Trial 3 | Trial 1;Trial 2;Trial 3 | Alphanumeric |
It is recommended that two trials be used to measure grip strength |
Beck M, Giess R, Wuerffel W, Magnus T, Ochs, G, Toyka KV. Comparison of Maximal Voluntary Isometric Contraction and Drachman's Hand-Held Dynamometry in Evaluating Patients with Amyotrophic Lateral Sclosis. Muscle Nerve. 1999; 22: 1265-1270. <br /><br />Bohannon RW. Hand-Held Dynamometry; Stability of Muscle Strength Over Multiple Measurements. Clinical Biomechanics. 1986: 2:74-77. <br /><br />Wang CY, Olson SL, Protas EJ. Test-Retest Strength Reliability: Hand-Held Dynamometry in Community-Dwelling Elderly Faller. Arch Phys Med Rehabil. 2002; 83: 811-5. <br /><br />Shefner J, Cedarbaum JM, Cudkowicz ME, Maragakis N, Lee J, Jones D, Watson ML, Mahoney K, Chen M, Saikali K, Mao J, Russell AJ, Hansen RL, Malik F, Wolff AA; Neals/Cytokinetics Study Team. Safety, tolerability and pharmacodynamics of a skeletal muscle activator in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2012;13(5):430–438. | Adult;Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | Grip Strength Fatigue | Muscle Strength Testing | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C10851 | Grip strength test indicator | GripStrengthTestInd | Indicator whether the grip strength testing was done | Indicator whether the grip strength testing was done | Was the grip strength fatigue testing done? | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
Choose one |
Shefner J, Cudkowicz ME, Maragakis N, Cedarbaum JM, Lee J, Jones D, Watson ML, Shaver K, Chen M, Saikali K, Mao J, Russell AK, Hansen L, Malik F, Wolff AA, for the NEALS/Cytokinetics Study Team. Safety, tolerability and pharmacodynamics of a skeletal muscle activator in Amyotrophic Lateral Sclerosis. (submitted for publication) | Adult;Pediatric | Supplemental | 3.00 | 2013-07-22 16:57:17.79 | Grip Strength Fatigue | Muscle Strength Testing | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C10852 | Grip strength test performed date and time | GripStrengthTestPerfDateTime | Date (and time, if applicable and known) that grip strength testing was done | Date (and time, if applicable and known) that grip strength testing was done | Date Performed | Date or Date & Time |
Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (ISO 8601 - https://www.iso.org/iso-8601-date-and-time-format.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.). |
Shefner J, Cedarbaum JM, Cudkowicz ME, Maragakis N, Lee J, Jones D, Watson ML, Mahoney K, Chen M, Saikali K, Mao J, Russell AJ, Hansen RL, Malik F, Wolff AA; Neals/Cytokinetics Study Team. Safety, tolerability and pharmacodynamics of a skeletal muscle activator in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2012;13(5):430–438.<br /><br />ISO 8601 - https://www.iso.org/iso-8601-date-and-time-format.html | Adult;Pediatric | Supplemental | 3.00 | 2013-07-22 16:57:17.79 | Grip Strength Fatigue | Muscle Strength Testing | Outcomes and End Points |
Free-Form Entry |
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| C10854 | Grip device width setting value | GripDeviceWidthSettingVal | Value of the width setting on the grip device used to test the participant/subject's grip strength | Value of the width setting on the grip device used to test the participant/subject's grip strength | Grip Device Width Setting | Numeric Values |
Record setting on grip strength instrument for each side |
Shefner J, Cedarbaum JM, Cudkowicz ME, Maragakis N, Lee J, Jones D, Watson ML, Mahoney K, Chen M, Saikali K, Mao J, Russell AJ, Hansen RL, Malik F, Wolff AA; Neals/Cytokinetics Study Team. Safety, tolerability and pharmacodynamics of a skeletal muscle activator in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2012;13(5):430–438. | Adult;Pediatric | Supplemental | 3.00 | 2013-07-22 16:57:17.79 | Grip Strength Fatigue | Muscle Strength Testing | Outcomes and End Points |
Free-Form Entry |
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| C10855 | Grip strength maximum measurement | GripStrengthMaxMeasr | Measurement of the maximum grip strength attained in the trial being recorded | Measurement of the maximum grip strength attained in the trial being recorded | Max Grip | Numeric Values |
Answer for each hand side in pounds, kilograms or newtons |
Shefner J, Cedarbaum JM, Cudkowicz ME, Maragakis N, Lee J, Jones D, Watson ML, Mahoney K, Chen M, Saikali K, Mao J, Russell AJ, Hansen RL, Malik F, Wolff AA; Neals/Cytokinetics Study Team. Safety, tolerability and pharmacodynamics of a skeletal muscle activator in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2012;13(5):430–438. | Adult;Pediatric | Supplemental | 3.00 | 2013-07-22 16:57:17.79 | Grip Strength Fatigue | Muscle Strength Testing | Outcomes and End Points |
Free-Form Entry |
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| C10856 | Grip strength unit of measure | GripStrengthUOM | Unit of measure (pounds, kilograms, or newtons) for the maximum grip strength attained or for the target in the trial being recorded | Unit of measure (pounds, kilograms, or newtons) for the maximum grip strength attained or for the target in the trial being recorded | Indicate units: pounds, kilograms, or newtons | lb;kg;N | Pounds;Kilograms;Newtons | Alphanumeric |
Choose one for each grip strength measurement |
Shefner J, Cedarbaum JM, Cudkowicz ME, Maragakis N, Lee J, Jones D, Watson ML, Mahoney K, Chen M, Saikali K, Mao J, Russell AJ, Hansen RL, Malik F, Wolff AA; Neals/Cytokinetics Study Team. Safety, tolerability and pharmacodynamics of a skeletal muscle activator in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2012;13(5):430–438. | Adult;Pediatric | Supplemental | 3.00 | 2013-07-22 16:57:17.79 | Grip Strength Fatigue | Muscle Strength Testing | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C10858 | Grip strength target value | GripStrengthTargetVal | Value of the target grip strength for the grip strength fatigue trial being recorded | Value of the target grip strength for the grip strength fatigue trial being recorded | Target | Numeric Values |
Answer for each hand side in pounds, kilograms or newtons |
Shefner J, Cedarbaum JM, Cudkowicz ME, Maragakis N, Lee J, Jones D, Watson ML, Mahoney K, Chen M, Saikali K, Mao J, Russell AJ, Hansen RL, Malik F, Wolff AA; Neals/Cytokinetics Study Team. Safety, tolerability and pharmacodynamics of a skeletal muscle activator in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2012;13(5):430–438. | Adult;Pediatric | Supplemental | 3.00 | 2013-07-22 16:57:17.79 | Grip Strength Fatigue | Muscle Strength Testing | Outcomes and End Points |
Free-Form Entry |
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| C10859 | Grip strength fatigue percent target value | GripStrengthFatigPctTargetVal | Value of (the percentage of) target grip strength for which grip hold duration is being measured in the grip strength fatigue trial being recorded | Value of the percentage of target grip strength for which grip hold duration is being measured in the grip strength fatigue trial being recorded | Percent of Target | 100% of Target;90% of Target;80% of Target;70% of Target;60% of Target | 100 percent of Target;90 percent of Target;80 percent of Target;70 percent of Target;60 percent of Target | Numeric Values |
Answer for each hand side in seconds. If the percent was not reached, record as 'percent not reached'. |
Shefner J, Cedarbaum JM, Cudkowicz ME, Maragakis N, Lee J, Jones D, Watson ML, Mahoney K, Chen M, Saikali K, Mao J, Russell AJ, Hansen RL, Malik F, Wolff AA; Neals/Cytokinetics Study Team. Safety, tolerability and pharmacodynamics of a skeletal muscle activator in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2012;13(5):430–438. | Adult;Pediatric | Supplemental | 3.00 | 2013-07-22 16:57:17.79 | Grip Strength Fatigue | Muscle Strength Testing | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C10860 | Grip strength fatigue percent target hold duration | GripStrgthFatigPctTgtHoldDur | Duration in seconds that the participant was able to hold the grip device at the indicated percentage of the target value in the grip strength fatigue trial being recorded | Duration in seconds that the participant was able to hold the grip device at the indicated percentage of the target value in the grip strength fatigue trial being recorded | Percent of Target (seconds) | Numeric Values |
Answer for each hand side in seconds. |
Shefner J, Cedarbaum JM, Cudkowicz ME, Maragakis N, Lee J, Jones D, Watson ML, Mahoney K, Chen M, Saikali K, Mao J, Russell AJ, Hansen RL, Malik F, Wolff AA; Neals/Cytokinetics Study Team. Safety, tolerability and pharmacodynamics of a skeletal muscle activator in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2012;13(5):430–438. | Adult;Pediatric | Supplemental | 3.00 | 2013-07-22 16:57:17.79 | Grip Strength Fatigue | Muscle Strength Testing | Outcomes and End Points |
Free-Form Entry |
0 | 100 | second | |||||||
| C00023 | Hand preference type | HandPrefTyp | Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusively | Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusivel | Handedness | Left hand;Right hand;Both hands;Unknown | Left hand;Right hand;Both hands;Unknown | Alphanumeric |
Choose one. The predominant hand does not have to be the hand that he/she writes with. Unknown should be used in the scenario for infants or other (rare) instances when handedness can not be known or is not yet developed. |
Shefner J, Cedarbaum JM, Cudkowicz ME, Maragakis N, Lee J, Jones D, Watson ML, Mahoney K, Chen M, Saikali K, Mao J, Russell AJ, Hansen RL, Malik F, Wolff AA; Neals/Cytokinetics Study Team. Safety, tolerability and pharmacodynamics of a skeletal muscle activator in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2012;13(5):430–438. | Adult;Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | Grip Strength Fatigue | Muscle Strength Testing | Outcomes and End Points |
Single Pre-Defined Value Selected |
2180147 | |||||||
| C17783 | Grip strength fatigue percent target not attain indicator | GripStrengthFatigPctTaNotAtInd | Indicator that the participant/subject did not attain the indicated percentage of the target value in the grip strength fatigue trial being recorded | Indicator that the participant/subject did not attain the indicated percentage of the target value in the grip strength fatigue trial being recorded | Percent not reached | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric |
If the percent was not reached check 'percent not reached' on CRF. |
Shefner J, Cedarbaum JM, Cudkowicz ME, Maragakis N, Lee J, Jones D, Watson ML, Mahoney K, Chen M, Saikali K, Mao J, Russell AJ, Hansen RL, Malik F, Wolff AA; Neals/Cytokinetics Study Team. Safety, tolerability and pharmacodynamics of a skeletal muscle activator in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2012;13(5):430–438. | Adult;Pediatric | Supplemental | 3.00 | 2013-07-22 16:57:17.79 | Grip Strength Fatigue | Muscle Strength Testing | Outcomes and End Points |
Single Pre-Defined Value Selected |
