CDE Detailed Report
Disease: Amyotrophic Lateral Sclerosis
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 |
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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 | Exploratory | 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 | Exploratory | 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 | Exploratory | 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 | Exploratory | 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 | Exploratory | 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 | Exploratory | 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 | Exploratory | 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 |
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| 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 | Handedness (2) | 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.<br /><br />http://www.meddean.luc.edu/lumen/MedEd/medicine/pulmonar/fellow/pftm_f.htm | 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, 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 | Exploratory | 3.00 | 2013-07-22 16:57:17.79 | Grip Strength Fatigue | Muscle Strength Testing | Outcomes and End Points |
Single Pre-Defined Value Selected |
