of0
Export
 
CDE Detailed Report
This report contains detailed information about the selected CDEs.
Note: If at least one CDE was selected from a copyright- or trademark-protected instrument/scale then all of the CDEs from that instrument/scale are included in this report.
Disease: Myotonic Muscular Dystrophy
Sub-Domain: Muscle Strength Testing
CRF: Grip Strength Fatigue
Item count: 12 (12 distinct CDEs)
CDE ID
CDE Name
Variable Name
Definition / Description
Question Text
Permissible Value
Description
Data Type
Instructions
References
Population
Classification (e.g., Core)
Version #
Version Date
Aliases for Variable Name
CRF Module / Guideline
© or TM
Sub-Domain
Domain
Previous Title
Size
Input Restrictions
Min Value
Max Value
Measurement Type
LOINC ID
SNOMED
caDSR ID
CDISC ID
C10851
Grip strength test indicator
GripStrengthTestInd
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
3.0
7/22/2013
Aliases for variable name not defined
Grip Strength Fatigue
Muscle Strength Testing
Outcomes and End Points
Grip strength testing performed indicator
 
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 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.

ISO 8601 - https://www.iso.org/iso-8601-date-and-time-format.html
Adult;Pediatric
Supplemental
3.0
7/22/2013
Aliases for variable name not defined
Grip Strength Fatigue
Muscle Strength Testing
Outcomes and End Points
Grip strength performed date and time
 
Free-Form Entry
       
C00023
Hand preference type
HandPrefTyp
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):430–438.
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Grip Strength Fatigue
Muscle Strength Testing
Outcomes and End Points
Hand preference type
 
Single Pre-Defined Value Selected
     
2180147
 
C02411
Laterality type
LatTyp
Laterality type relative to the anatomic site of the body examined or affected
Left or Right Grip Strength
Right;Left;
Right;Left;
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
3.0
8/28/2013
Aliases for variable name not defined
Grip Strength Fatigue
Muscle Strength Testing
Outcomes and End Points
Laterality type
 
Single Pre-Defined Value Selected
       
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
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
3.0
7/22/2013
Aliases for variable name not defined
Grip Strength Fatigue
Muscle Strength Testing
Outcomes and End Points
Grip strength device width setting value
 
Free-Form Entry
       
C10171
Trial number
TrialNum
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.

Bohannon RW. Hand-Held Dynamometry; Stability of Muscle Strength Over Multiple Measurements. Clinical Biomechanics. 1986: 2:74-77.

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.

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
3.0
7/25/2013
Aliases for variable name not defined
Grip Strength Fatigue
Muscle Strength Testing
Outcomes and End Points
Trial number
 
Single Pre-Defined Value Selected
       
C10855
Grip strength maximum measurement
GripStrengthMaxMeasr
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
3.0
7/22/2013
Aliases for variable name not defined
Grip Strength Fatigue
Muscle Strength Testing
Outcomes and End Points
Grip strength maximum measurement
 
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
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
3.0
7/22/2013
Aliases for variable name not defined
Grip Strength Fatigue
Muscle Strength Testing
Outcomes and End Points
Grip strength unit of measure
 
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
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
3.0
7/22/2013
Aliases for variable name not defined
Grip Strength Fatigue
Muscle Strength Testing
Outcomes and End Points
Grip strength fatigue target weight value
 
Free-Form Entry
       
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
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
3.0
7/22/2013
Aliases for variable name not defined
Grip Strength Fatigue
Muscle Strength Testing
Outcomes and End Points
  
Single Pre-Defined Value Selected
       
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
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
3.0
7/22/2013
Aliases for variable name not defined
Grip Strength Fatigue
Muscle Strength Testing
Outcomes and End Points
Grip strength fatigue percentage of target value
 
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
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
3.0
7/22/2013
Aliases for variable name not defined
Grip Strength Fatigue
Muscle Strength Testing
Outcomes and End Points
Grip strength fatigue percentage of target reached duration
 
Free-Form Entry
0
100
second
    
12-17-2018
Page 1 of 1