Table 2.
Strengths and recommendations for use of select UE clinical outcome assessments
| Primary construct | Strengths | Recommendations for use in clinical trials | |
|---|---|---|---|
| Upper extremity motor scores (UEMS) derived from ISNCSCI | Upper extremity strength | SCI specific | May be used for all trial phases (Phase I safety deterioration), Phase II, and III safety and efficacy) |
| Web based and in person training available through the American Spinal Injury Association | If a comprehensive assessment of UE muscle impairment is required (e.g., shoulder function, comprehensive hand function) non-key muscles must be added as the UEMS only assesses 5 (bilateral) key muscles | ||
| Can be assessed early post injury in all severities of SCI | |||
| Psychometrics established in pediatric and adult populations | |||
| Well established, standardized test with normative data available | |||
| Spinal Cord Independence Measure version III (SCIM III)—self-care and grooming sub-scales | Independence level in ADLs | SCI specific | Phase II (secondary or exploratory), III (primary or secondary) with impairment-based measure to differentiate recovery from compensation |
| Validated for observation, interview, or self-report | Development of a manual is needed to ensure systematic administration | ||
| Commonly used test with normative data available | If assessing high cervical injury supplement with another measure | ||
| Psychometrics established in adults and youths (self-report) | Consider co-administration of a COA with a construct focusing on UE function | ||
| Capabilities of Upper Extremities Questionnaire (CUE-Q) | Proximal and distal UE function | SCI specific | Phase II, III (secondary or exploratory) |
| Validated in adolescent and adult populations | PRO—should be used in conjunction with an impairment-based measure | ||
| Assesses proximal and distal function | Consider language and cultural differences when used with non-English speakers | ||
| Items worded in a way to minimize compensation | |||
| Jebsen Taylor Hand Function Test | Hand function | Standardized performance-based measure with normative references in healthy controls | Phase II, III (secondary or exploratory) |
| Requires mid-line crossing | Consider addition of SCI-specific measures due to limited psychometric testing in SCI | ||
| Kit available for purchase | Useful for individuals with incomplete mid-lower level cervical injuries | ||
| Consider an additional measure if assessing opening and closing of the hand | |||
| An impairment-based measure should be administered in conjunction to differentiate recovery from compensation | |||
| Capabilities of UE function test(CUE-T) | Proximal and distal UE function | SCI specific | Phase II, III (secondary or exploratory) |
| Items designed to reflect requirements of ADLsCompensation not allowed | Consider additional measures in conjunction as responsiveness has not been published | ||
| Components of proximal and distal UE function | Useful with incomplete SCI | ||
| Assesses uni- and bi-manual function | Requires tolerance to sitting | ||
| Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) | Multidimensional—hand impairment and function | SCI specific | Strength and sensibility: Phase I (safety—deterioration), II and III (safety and efficacy—primary or secondary) |
| Scores reduced with compensation | Prehension: Phase II (secondary or exploratory), Phase III (primary or secondary) | ||
| Manual and kit available for purchase | Useful to assess hand function | ||
| Normative data available | Supplement with other measures if assessing entire upper limb | ||
| Prehension component requires tolerance to sitting | |||
| Spinal Cord Injury-Functional Index (SCI-FI) Computer Adaptive Testing (CAT) or Short Form (self-care and fine motor) | Linearized, comprehensive assessment of function across multiple domains | SCI specific | Phase II, III (secondary or exploratory) |
| Large bank of UE items including fine motor | PRO—should be used in conjunction with an impairment-based measure | ||
| Available as short form or computer adaptive test (two versions: one with use of technology, one does not allow use of technology) | Consider language and cultural differences when used with non-English speakers | ||
| Links to pediatric SCI-FI | |||
| Spinal Cord Ability Ruler (SCAR) | Linearized measure of impairment and function | SCI specific | Phase II, III (secondary or exploratory) |
| Linear assessment | Consider other measures for central cord syndrome | ||
| Simulated validation (using Rasch analysis) from two databases | Consider the addition of a measure with upper extremity function construct | ||
| Statistically combines two common, validated measures (ISNCSCI and SCIM III) so no additional data collection required |
• Measures considered at the workshop and in this table are listed in the National Institutes of Neurological Disorders and Stroke (NINDS), SCI Common Data Elements (CDEs), or are under development. Recommendations are based on the views of the authors, considering the following: goals of each trial phase (see Table 1), validation (published psychometrics including responsiveness), type of assessment (observed vs. patient reported), and availability. For example, for a Phase III trial using a measure for which validation is not complete or the COA is a patient-reported outcome, the measure is recommended as secondary or exploratory. If validation is complete, and the measure is assessed by observation, the measure is recommended as a primary or secondary outcome measure
• Please note the following websites contain additional information on details, psychometrics, and recommendations for these and other UE COAs:
○NINDS, CDEs (SCI specific): https://www.commondataelements.ninds.nih.gov/SCI.aspx#tab=Data_Standards
○Spinal Cord Injury Research Evidence (SCI specific): https://scireproject.com/outcome-measures/
○SCI Evidence Database to Guide Effectiveness (SCI specific): http://www.neuropt.org/professional-resources/neurology-section-outcome-measures-recommendations/spinal-cord-injury
○Rehab measures.org (non-SCI specific): http://www.rehabmeasures.org/default.aspx