CDE Detailed Report

Disease: Myotonic Muscular Dystrophy
Sub-Domain: Muscle Strength Testing
CRF: Grip Strength Fatigue

Displaying 1 - 12 of 12
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (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 / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
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&#8211;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

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

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&#8211;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

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&#8211;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

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&#8211;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

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&#8211;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

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&#8211;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

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&#8211;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

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&#8211;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 exclusively. 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&#8211;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&#8211;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

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&#8211;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

CSV