CDE Detailed Report
Disease: Facioscapulohumeral Muscular Dystrophy
Subdomain Name: Muscle Strength Testing
CRF: Grip Strength
Displaying 1 - 8 of 8
Subdomain Name: Muscle Strength Testing
CRF: Grip Strength
Displaying 1 - 8 of 8
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. This CDE is highly recommended for FSHD studies involving muscle strength testing. |
Personius, K. E., S. Pandya, et al. (1994). "Facioscapulohumeral dystrophy natural history study: standardization of testing procedures and reliability of measurements. The FSH DY Group." Phys Ther 74(3): 253-263.<br /><br />Kissel, J. T., M. P. McDermott, et al. (2001). "Randomized, double-blind, placebo-controlled trial of albuterol in facioscapulohumeral dystrophy." Neurology 57(8): 1434-1440.<br />Wagner, K. R., J. L. Fleckenstein, et al. (2008). "A phase I/Iitrial of MYO-029 in adult subjects with muscular dystrophy." Ann Neurol 63(5): 561-571.<br /><br />van der Kooi, E. L., O. J. Vogels, et al. (2004). "Strength training and albuterol in facioscapulohumeral muscular dystrophy." Neurology 63(4): 702-708.<br /><br />Cooper R, Kuh D, Hardy R. Objectively measured physical capability levels and mortality: systematic review and meta-analysis. BMJ. 2010;341:c4467.<br /><br />Newman AB, Kupelian V, Visser M, Simonsick EM, Goodpaster BH, Kritchevsky SB, et al. Strength, but not muscle mass, is associated with mortality in the health, aging and body composition study cohort. The journals of gerontology Series A, Biological sciences and medical sciences. 2006;61(1):72-77. | Adult;Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | Grip Strength | Muscle Strength Testing | Outcomes and End Points |
Single Pre-Defined Value Selected |
2180147 | |||||||
| 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 | Grip Strength Hand | Left;Right | Left;Right | Alphanumeric |
Record the grip strength results for each hand side. This CDE is highly recommended for FSHD studies involving muscle strength testing. |
Personius, K. E., S. Pandya, et al. (1994). "Facioscapulohumeral dystrophy natural history study: standardization of testing procedures and reliability of measurements. The FSH DY Group." Phys Ther 74(3): 253-263.<br /><br />Kissel, J. T., M. P. McDermott, et al. (2001). "Randomized, double-blind, placebo-controlled trial of albuterol in facioscapulohumeral dystrophy." Neurology 57(8): 1434-1440.<br /><br />Wagner, K. R., J. L. Fleckenstein, et al. (2008). "A phase I/Iitrial of MYO-029 in adult subjects with muscular dystrophy." Ann Neurol 63(5): 561-571.<br /><br />van der Kooi, E. L., O. J. Vogels, et al. (2004). "Strength training and albuterol in facioscapulohumeral muscular dystrophy." Neurology 63(4): 702-708.<br /><br />Cooper R, Kuh D, Hardy R. Objectively measured physical capability levels and mortality: systematic review and meta-analysis. BMJ. 2010;341:c4467. <br /><br />Newman AB, Kupelian V, Visser M, Simonsick EM, Goodpaster BH, Kritchevsky SB, et al. Strength, but not muscle mass, is associated with mortality in the health, aging and body composition study cohort. The journals of gerontology Series A, Biological sciences and medical sciences. 2006;61(1):72-77. | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Grip Strength | Muscle Strength Testing | Outcomes and End Points |
Single Pre-Defined Value Selected |
||||||||
| 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 1;Trial 2 | Alphanumeric |
It is recommended that two trials be used to measure grip strength. This CDE is highly recommended for FSHD studies involving muscle strength testing. |
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 />Personius, K. E., S. Pandya, et al. (1994). "Facioscapulohumeral dystrophy natural history study: standardization of testing procedures and reliability of measurements. The FSH DY Group." Phys Ther 74(3): 253-263.<br /><br />Kissel, J. T., M. P. McDermott, et al. (2001). "Randomized, double-blind, placebo-controlled trial of albuterol in facioscapulohumeral dystrophy." Neurology 57(8): 1434-1440.<br /><br />Wagner, K. R., J. L. Fleckenstein, et al. (2008). "A phase I/Iitrial of MYO-029 in adult subjects with muscular dystrophy." Ann Neurol 63(5): 561-571.<br /><br />van der Kooi, E. L., O. J. Vogels, et al. (2004). "Strength training and albuterol in facioscapulohumeral muscular dystrophy." Neurology 63(4): 702-708.<br /><br />Cooper R, Kuh D, Hardy R. Objectively measured physical capability levels and mortality: systematic review and meta-analysis. BMJ. 2010;341:c4467. <br /><br />Newman AB, Kupelian V, Visser M, Simonsick EM, Goodpaster BH, Kritchevsky SB, et al. Strength, but not muscle mass, is associated with mortality in the health, aging and body composition study cohort. The journals of gerontology Series A, Biological sciences and medical sciences. 2006;61(1):72-77. | Adult;Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | Grip Strength | 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 hand grip strength testing performed? | Yes;No | Yes;No | Alphanumeric |
Choose one. This CDE is highly recommended for FSHD studies involving muscle strength testing. |
Personius, K. E., S. Pandya, et al. (1994). "Facioscapulohumeral dystrophy natural history study: standardization of testing procedures and reliability of measurements. The FSH DY Group." Phys Ther 74(3): 253-263.<br /><br />Kissel, J. T., M. P. McDermott, et al. (2001). "Randomized, double-blind, placebo-controlled trial of albuterol in facioscapulohumeral dystrophy." Neurology 57(8): 1434-1440.<br />Wagner, K. R., J. L. Fleckenstein, et al. (2008). "A phase I/Iitrial of MYO-029 in adult subjects with muscular dystrophy." Ann Neurol 63(5): 561-571.<br /><br />van der Kooi, E. L., O. J. Vogels, et al. (2004). "Strength training and albuterol in facioscapulohumeral muscular dystrophy." Neurology 63(4): 702-708.<br /><br />Cooper R, Kuh D, Hardy R. Objectively measured physical capability levels and mortality: systematic review and meta-analysis. BMJ. 2010;341:c4467. Epub 2010/09/11. doi: 10.1136/bmj.c4467. PubMed PMID: 20829298; PubMed Central PMCID: PMC2938886.<br /><br />Newman AB, Kupelian V, Visser M, Simonsick EM, Goodpaster BH, Kritchevsky SB, et al. Strength, but not muscle mass, is associated with mortality in the health, aging and body composition study cohort. The journals of gerontology Series A, Biological sciences and medical sciences. 2006;61(1):72-77. | Adult;Pediatric | Supplemental | 3.00 | 2013-07-22 16:57:17.79 | Grip Strength | 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.) This CDE is highly recommended for FSHD studies involving muscle strength testing. |
ISO 8601 - https://www.iso.org/iso-8601-date-and-time-format.html <br /><br />Personius, K. E., S. Pandya, et al. (1994). "Facioscapulohumeral dystrophy natural history study: standardization of testing procedures and reliability of measurements. The FSH DY Group." Phys Ther 74(3): 253-263.<br /><br />Kissel, J. T., M. P. McDermott, et al. (2001). "Randomized, double-blind, placebo-controlled trial of albuterol in facioscapulohumeral dystrophy." Neurology 57(8): 1434-1440.<br /><br />Wagner, K. R., J. L. Fleckenstein, et al. (2008). "A phase I/Iitrial of MYO-029 in adult subjects with muscular dystrophy." Ann Neurol 63(5): 561-571.<br /><br />van der Kooi, E. L., O. J. Vogels, et al. (2004). "Strength training and albuterol in facioscapulohumeral muscular dystrophy." Neurology 63(4): 702-708.<br /><br />Cooper R, Kuh D, Hardy R. Objectively measured physical capability levels and mortality: systematic review and meta-analysis. BMJ. 2010;341:c4467.<br /><br />Newman AB, Kupelian V, Visser M, Simonsick EM, Goodpaster BH, Kritchevsky SB, et al. Strength, but not muscle mass, is associated with mortality in the health, aging and body composition study cohort. The journals of gerontology Series A, Biological sciences and medical sciences. 2006;61(1):72-77. | Adult;Pediatric | Supplemental | 3.00 | 2013-07-22 16:57:17.79 | Grip Strength | 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. This CDE is highly recommended for FSHD studies involving muscle strength testing. |
Personius, K. E., S. Pandya, et al. (1994). "Facioscapulohumeral dystrophy natural history study: standardization of testing procedures and reliability of measurements. The FSH DY Group." Phys Ther 74(3): 253-263.<br /><br />Kissel, J. T., M. P. McDermott, et al. (2001). "Randomized, double-blind, placebo-controlled trial of albuterol in facioscapulohumeral dystrophy." Neurology 57(8): 1434-1440.<br /><br />Wagner, K. R., J. L. Fleckenstein, et al. (2008). "A phase I/Iitrial of MYO-029 in adult subjects with muscular dystrophy." Ann Neurol 63(5): 561-571.<br /><br />van der Kooi, E. L., O. J. Vogels, et al. (2004). "Strength training and albuterol in facioscapulohumeral muscular dystrophy." Neurology 63(4): 702-708.<br /><br />Cooper R, Kuh D, Hardy R. Objectively measured physical capability levels and mortality: systematic review and meta-analysis. BMJ. 2010;341:c4467. E<br /><br />Newman AB, Kupelian V, Visser M, Simonsick EM, Goodpaster BH, Kritchevsky SB, et al. Strength, but not muscle mass, is associated with mortality in the health, aging and body composition study cohort. The journals of gerontology Series A, Biological sciences and medical sciences. 2006;61(1):72-77. | Adult;Pediatric | Supplemental | 3.00 | 2013-07-22 16:57:17.79 | Grip Strength | 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. This CDE is highly recommended for FSHD studies involving muscle strength testing. |
Personius, K. E., S. Pandya, et al. (1994). "Facioscapulohumeral dystrophy natural history study: standardization of testing procedures and reliability of measurements. The FSH DY Group." Phys Ther 74(3): 253-263.<br /><br />Kissel, J. T., M. P. McDermott, et al. (2001). "Randomized, double-blind, placebo-controlled trial of albuterol in facioscapulohumeral dystrophy." Neurology 57(8): 1434-1440.<br /><br />Wagner, K. R., J. L. Fleckenstein, et al. (2008). "A phase I/Iitrial of MYO-029 in adult subjects with muscular dystrophy." Ann Neurol 63(5): 561-571.<br /><br />van der Kooi, E. L., O. J. Vogels, et al. (2004). "Strength training and albuterol in facioscapulohumeral muscular dystrophy." Neurology 63(4): 702-708.<br /><br />Cooper R, Kuh D, Hardy R. Objectively measured physical capability levels and mortality: systematic review and meta-analysis. BMJ. 2010;341:c4467. <br /><br />Newman AB, Kupelian V, Visser M, Simonsick EM, Goodpaster BH, Kritchevsky SB, et al. Strength, but not muscle mass, is associated with mortality in the health, aging and body composition study cohort. The journals of gerontology Series A, Biological sciences and medical sciences. 2006;61(1):72-77. | Adult;Pediatric | Supplemental | 3.00 | 2013-07-22 16:57:17.79 | Grip Strength | 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. This CDE is highly recommended for FSHD studies involving muscle strength testing. |
Personius, K. E., S. Pandya, et al. (1994). "Facioscapulohumeral dystrophy natural history study: standardization of testing procedures and reliability of measurements. The FSH DY Group." Phys Ther 74(3): 253-263.<br /><br />Kissel, J. T., M. P. McDermott, et al. (2001). "Randomized, double-blind, placebo-controlled trial of albuterol in facioscapulohumeral dystrophy." Neurology 57(8): 1434-1440.<br />Wagner, K. R., J. L. Fleckenstein, et al. (2008). "A phase I/Iitrial of MYO-029 in adult subjects with muscular dystrophy." Ann Neurol 63(5): 561-571.<br /><br />van der Kooi, E. L., O. J. Vogels, et al. (2004). "Strength training and albuterol in facioscapulohumeral muscular dystrophy." Neurology 63(4): 702-708.<br /><br />Cooper R, Kuh D, Hardy R. Objectively measured physical capability levels and mortality: systematic review and meta-analysis. BMJ. 2010;341:c4467. <br /><br />Newman AB, Kupelian V, Visser M, Simonsick EM, Goodpaster BH, Kritchevsky SB, et al. Strength, but not muscle mass, is associated with mortality in the health, aging and body composition study cohort. The journals of gerontology Series A, Biological sciences and medical sciences. 2006;61(1):72-77. | Adult;Pediatric | Supplemental | 3.00 | 2013-07-22 16:57:17.79 | Grip Strength | Muscle Strength Testing | Outcomes and End Points |
Single Pre-Defined Value Selected |
