Abstract
Context
The number of patients with cervical spinal cord injury (CSCI) is increasing, and the Capabilities of Upper Extremity Test (CUE-T) is recommended for introduction in clinical trials. We calculated the minimal clinically important difference (MCID) of the CUE-T using an adjustment model with an interval of 1 month.
Design
This was a prospective study.
Setting
This study was conducted with participants from the Chiba Rehabilitation Center in Japan.
Participants
The participants were patients with subacute CSCI.
Interventions
The CUE-T and spinal cord independence measure (SCIM) III were performed twice within an interval of 1 month.
Outcome Measures
The MCID was calculated using an adjustment model based on logistic regression analysis. The participants were classified into an improvement group and a non-improvement group based on the amount of change in the two evaluations using the 10-point SCIM III MCID as an anchor.
Results
There were 52 participants (56.8 ± 13.5 years old, 45 men/7 women) with complete or incomplete CSCI: 18 in the improvement group and 34 in the non-improvement group. A significant regression equation was obtained when calculating the MCID, and the total, hand, and side scores were 7.7, 2.0, and 3.7 points, respectively.
Conclusion
The calculated MCID of the CUE-T in this study was 7.7 points. The results of this study provide useful criteria for implementation in clinical trials. Future studies should use patient-reported outcomes, a more recommended anchor, and calculate the MCID using methods such as the patient’s condition.
Keywords: Minimal clinically important difference, Outcome measure, Rehabilitation, Spinal cord injuries, Upper limb function
Introduction
The worldwide incidence of spinal cord injury (SCI) is elucidated to be 23 per million people and has been increasing in recent years (1, 2). In particular, cervical SCI (CSCI) accounts for the majority of SCIs in developed countries (3, 4). CSCI causes severe functional impairment in the upper limbs and has a significant impact on activities of daily living (ADL) and quality of life (5, 6). Interventions such as functional electrostimulation therapy, robotics, and cell or drug therapy have been used to improve CSCI upper limb dysfunction (7–9).
Methods for the detailed evaluation of upper limb dysfunction in CSCI have been investigated. The International Standards for Neurological Classification of SCI (ISNCSCI) upper limb motor score (UEMS), Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP), and Capabilities of Upper Extremity Test (CUE-T) were recommended in previous studies and widely implemented in clinical trials of CSCI to evaluate upper limb function (10). The UEMS is the total score of the manual muscle test. The GRASSP mainly evaluates fine movements. The CUE-T enables a more detailed evaluation of fine, coarse, and two-handed movements in the context of object manipulation (11–13). This test has high reliability, validity, and responsiveness (11–13); however, the minimal clinically important difference (MCID) of the CUE-T has been calculated using only one method.
The MCID is the minimum change value that can be interpreted as a beneficial change in patients, and its importance has been advocated in clinical trials and clinical practice. The MCID examines whether there is a statistical difference in a score before and after treatment in a certain group and allows better clinical interpretation from the decision of whether individual cases have reached the MCID (14). However, few have reports calculated the MCID score when evaluating for SCI (15). MCID calculation methods include a data distribution method and an anchor method that uses external indicators as anchors (16). The anchor method is more recommended, and a method has been developed to calculate an accurate estimate by adjusting according to the bias in the number of participants each group when classifying participants into an “improvement group” and a “non-improvement group” (17–19).
A previous study determined the MCID of the CUE-T using only one method of collecting data at 3-month intervals and calculating the average value of the “improvement group” classified by the anchor method (12). The MCID varies depending on the calculation method, causing difficulty in the interpretation and application of the results in clinical practice (20). When using MCID in clinical trials and clinical practice, the content of the intervention and the calculation conditions of MCID should be close to the participant's condition. Most intervention periods in clinical trials of CSCI for upper limb dysfunction ranged from 6 to 8 weeks (9). This duration is shorter than the interventions for MCID calculation in previous studies. This study aimed to contribute to the development of rehabilitation for upper limb dysfunction in CSCI by calculating the MCID corresponding to shorter intervention periods using a more recommended statistical method, which would allow the determination of efficacy of interventions in multiple clinical trials and clinical practice.
Participants and methods
Participants
This was a prospective study. The inclusion criteria were patients with subacute CSCI within 9 months of injury (21) who received rehabilitation at the Chiba Rehabilitation Center in Japan from 2019 to 2023. The exclusion criteria were patients with upper limb dysfunction due to reasons other than spinal cord injury (stroke, incurable neurological diseases, congenital disorders such as cerebral palsy and spina bifida, and fractures and peripheral neuropathy receiving treatment), difficulty in understanding the examination content due to cognitive or mental dysfunction (comprehension item of the functional independence measure of 5 points or more), and a CUE-T score of 0 on two measurements.
Ethical consideration
This study was approved by the Ethical Review Committees of the Ibaraki Prefectural University of Health Sciences (No. 1036) and Chiba Rehabilitation Center (approval no. Medical 4-6). Participants were informed of the study in writing and provided with the option to opt out. Informed consent was obtained from all the participants.
Interventions
The CUE-T and the spinal cord independence measure (SCIM) III were evaluated twice within a 1-month interval (within 2 months at most) (Appendix A). This study aimed to estimate the important changes in upper limb function in patients with CSCI. The interventions were not controlled. The participants received 1–2 h of conventional occupational therapy (OT) and physical therapy (PT) daily during the two data collection periods (Fig. 1). OT and PT included muscle strength training, electrical stimulation therapy, upper extremity function training, and ADL, standing, and walking practice.
Figure 1.
Flow diagram of this study sample of participants. Data collection flow for this study.
Data collection
The collected data included sex, age, duration of injury (days) at baseline and follow up, ISNCSCI American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS), neurological level of injury (NLI), CUE-T, and SCIM III. Each evaluation was performed by a registered occupational therapist (OTR) who had received training at Chiba Rehabilitation Center. In addition, CUE-T and SCIM III were performed within 1 week by the same OTR and were not blinded. In some cases, the OTR responsible for the rehabilitation of participants performed the evaluation.
Capabilities of upper extremity test (CUE-T)
The CUE-T is a CSCI-specific upper limb function evaluation method (12, 13). The evaluation items are as follows: (1) Push-ups and lifting weights with both hands, (2) Reaching movements in various directions and wrist joint movements as gross movements, and (3) Measurement of pinch strength and grip strength and manipulation of items as fine movements. The CUE-T contains a total of 17 items for confirmation and measurement, such as the speed at which items are manipulated. The scoring method includes the number of designated actions in 30 s, the speed of object manipulation, grip strength, and pinch strength, and each item is scored from 0 to 4 points. The total score ranges from a minimum of 0 points to a maximum of 128 points. Furthermore, it is possible to derive the hand score (36 points on one side) with only fine movements and the side score (60 points on one side) excluding both hands (12, 13). Regarding the hand and side scores of the CUE-T, the upper limb, which had better results in the initial evaluation, was considered to have a greater effect on ADL and was calculated as the advantage limb. In cases with the same score on both sides, we considered the dominant hand to be the one dominant before the injury.
Spinal cord independence measure (SCIM) III
The SCIM III is a comprehensive disability rating scale that has been designed specifically for patients with spinal cord lesions (22, 23). The SCIM III is scored according to the patient’s performance in three categories: “self-care,” which consists of eating, bathing, dressing, and grooming; “respiration and sphincter management,” which consists of breathing, urination, bowel management, and toilet use; and “mobility,” which consists of various transfers between the room and toilet or indoor and outdoor settings and mobility skills (22, 23). The total score ranges from a minimum of 0 to a maximum of 100 points (22, 23).
Statistical analysis
The study’s external anchor was an MCID of 10 points in the SCIM III score. The MCID was calculated using 0.5 × SD (14), a formula frequently reported in distribution methods and used as the standard, which closely aligns with the conditions of the participants in this study (14).
We calculated the amount of change in the two total CUE-T, side, hand, and total SCIM III scores. The Shapiro–Wilk test was used to verify the normality of the data. We calculated the correlation coefficient between the amount of change in the total CUE-T, side, hand, and total SCIM III scores. The criterion for SCIM III scores to be an appropriate anchor was a correlation coefficient of 0.3 or higher (24).
The participants were classified into two groups based on the amount of change in the total SCIM III score: those who reached an MCID of 10 points (25) in the total SCIM III score comprised the “improvement group”, and those who did not comprised the “non-improvement group.” A regression equation was calculated using logistic regression analysis, with the binary value (improvement group or non-improvement group) classified by the SCIM III MCID as the dependent variable (MCIDadjust) and the total CUE-T, side, and hand scores as the independent variables. Logistic regression analysis was performed to calculate each total CUE-T, side, and hand score, with the independent variables entered one at a time. The MCIDadjust was calculated using the adjustment formula reported by Terluin B (18), which can correct the bias between the improvement and non-improvement groups using the obtained regression formula. Furthermore, we analyzed the statistical assumptions of logistic regression. Given that only one independent variable was included in each logistic regression analysis, we analyzed the data for strongly influential outliers and linearity in the logit transformation of continuous variables (26). The goodness-of-fit regression equation obtained using the logistic regression analysis was verified by the Hosmer and Lemeshow test. A likelihood ratio of 1 was defined to calculate the MCIDadjust (17, 18, 27).
In addition, the MCID was calculated using the distribution method (MCIDdistribution) by “0.5 × standard deviation (SD) of the changed score” (14, 28), which is a widely used formula in distribution methods.
Regarding sensitivity analysis of the calculated MCID, the MCID was calculated for the data of the group of incomplete injuries, the group aged < 65 years (< 65 years), and the group within 6 months of injury (< 6 months).
All statistical analyses were performed using SPSS Statistics 29 (IBM, Armonk, New York) and Microsoft Excel 2019 (Microsoft, Redmond, Washington). Statistical significance was set at P-value < 0.05.
Sample size
There is no established method for determining a suitable sample size when calculating the MCID. Therefore, the required sample size was set at 50 or more participants, according to previous studies (24).
Results
Of the 61 participants screened for this study, we excluded two who had upper limb dysfunction due to diseases other than spinal cord injury, five who had difficulty with follow up, and one who had a CUE-T score of 0 points on two measurements (Fig. 1). Therefore, 52 participants (56.8 ± 13.5 years old, 45 men/7 women, AIS-A: 8, AIS-B: 6, AIS-C: 14, AIS-D: 24) were analyzed ( Table 1). Thirty-eight participants (73% of the total) had NLI at C4 and C5 (Table 1). One participant had a previous stroke but was included since he was asymptomatic. Overall, 18 participants were classified into an improvement group and 34 into a non-improvement group using the anchor method. Table 2 shows the baseline, follow up, and change scores for each group.
Table 1.
Participants for all samples.
| All sample | ||
|---|---|---|
| n (male/female) | 52 (45/7) | |
| Age, years | 56.8 (13.5) | |
| Days from injury to baseline assessment, days | 98,7 (61.4) | |
| Days from injury to follow up assessment, days | 132.6 (63.1) | |
| AIS | A | 8 |
| B | 6 | |
| C | 14 | |
| D | 24 | |
| NLI | C1 | 1 |
| C2 | 0 | |
| C3 | 5 | |
| C4 | 21 | |
| C5 | 17 | |
| C6 | 2 | |
| C7 | 5 | |
| C8 | 1 | |
| Th1 | 0 | |
| CUE-T total baseline | 42.6 (32.9) | |
| CUE-T total follow up | 48.9 (34.5) | |
| CUE-T hand baseline | 10.1 (10.2) | |
| CUE-T hand follow up | 11.8 (11.0) | |
| CUE-T side baseline | 21.8 (15.8) | |
| CUE-T side follow up | 24.8 (16.9) | |
| SCIM III total baseline | 27.0 (25.2) | |
| SCIM III total follow up | 35.6 (27.9) | |
AIS, American Spinal Injury Association (ASIA) Impairment Scale; NLI, Neurological level of injury; CUE-T, Capabilities of Upper Extremity Test; SCIM, Spinal cord independence measure.
Table 2.
Baseline, follow up, and change scores in the improvement and non-improvement groups.
| Improvement (n = 18) | Non-Improvement (n = 34) | |||||
|---|---|---|---|---|---|---|
| Baseline | Follow up | Change score | Baseline | Follow up | Change score | |
| CUE-T total | 52.8 (26.4) | 62.9 (27.7) | 10.0 (6.9) | 35.6 (35.1) | 39.5 (37.0) | 3.8 (5.5) |
| Hand | 13.0 (8.1) | 15.8 (8.9) | 2.8 (2.7) | 8.1 (11.0) | 9.0 (11.4) | 0.9 (1.2) |
| Side | 27.3 (12.0) | 31.9 (13.0) | 4.5 (3.3) | 18.0 (17.0) | 20.0 (17.6) | 2.0 (2.5) |
CUE-T, Capabilities of Upper Extremity Test.
The Shapiro–Wilk test did not indicate a normal distribution (P > 0.05). Spearman's rank correlation coefficient (rs) was calculated for the amount of change in each of the evaluation scores of the SCIM III and CUE-T with the following results: total CUE-T, rs = 0.677, 95% confidence interval (CI) [0.489–0.804], (P < 0.01); hand, rs = 0.529, 95% CI [0.291–0.705], (P < 0.01); and side, rs = 0.611, 95%CI [0.398–0.761], (P < 0.01). No strongly influential outliers >4SD (26) from the mean were observed, and linearity was indicated in the logit transformation of continuous variables. The MCIDadjust indicated a significant regression equation after logistic regression analysis (P < 0.01), and the Hosmer and Lemeshow test also demonstrated good results (total CUE-T: P = 0.242, hand: P = 0.281, side: P = 0.051). The MCIDadjust for the total CUE-T score was calculated to be 7.7 points using a formula (18) from a previous study and the obtained regression equation, and the MCIDdistribution was 3.4 points (Table 3).
Table 3.
CUE-T MCID for all the participants.
| CUE-T total | CUE-T hand | CUE-T side | |
|---|---|---|---|
| MCIDadjust | 7.7 | 2.0 | 3.7 |
| MCIDdistribution | 3.4 | 1.1 | 1.6 |
CUE-T, Capabilities of Upper Extremity Test; MCID, minimal clinically important difference.
In the sensitivity analysis, 38 participants comprised the group with incomplete injuries only (17 in the improvement group, 21 in the non-improvement group), 31 comprised the group < 65 years (11 in the improvement group, 20 in the non-improvement group), and 42 comprised the group < 6 months (18 in the improvement group, 24 in the non-improvement group)(Appendix B). The MCIDadjust was approximately the same in all these samples (showed a difference of only 0.1–1.0 points) (Appendix C). The MCIDdistribution showed a difference of 0.1 points for all the items (Appendix C).
Discussion
We obtained new findings on the MCID of CUE-T scores in subacute CSCI. In this study, the MCID of the CUE-T in subacute CSCI was estimated to be 7.7 points (hand 2.0 points, side 3.7 points). The results of this study may contribute to the interpretation of changes in CUE-T scores in clinical trials and clinical situations of subacute CSCI.
The MCIDadjust calculated in this study was lower than that calculated in a previous study, which was 11.7–11.9 points (12). The previous study used the method of calculating the mean value of the “improvement group” classified by the anchor method, and the two evaluation periods were 3 months (12). In contrast, our study calculated the MCID using data collected at intervals of 1 month, which was shorter than the interval used in the previous study. The intervention period in a previous clinical trial of CSCI upper limb dysfunction was as short as 3 weeks (9); therefore, the MCID obtained in this study may be useful in future clinical trials and clinical practice. The MCID was calculated using different methods. A low MCID value may overestimate the effect of a treatment, whereas a high MCID value may incorrectly classify a treatment as ineffective when the treatment is beneficial (20). When MCID is used in clinical trials or clinical practice, intervention methods and MCID calculation methods should be close to the participant's condition to enable more accurate and effective decisions. Therefore, we recommend that the MCID estimated in this study is be used in various clinical trials.
The MCID was calculated using adjusted models. This method has demonstrated greater accuracy in classifying subjects into improvement and non-improvement groups using external anchors, particularly when the improvement group is less than 50% of all participants (17–19). The percentage of participants in the improvement group in this study was 35%, which matched the criteria of the previous studies (17–19). Furthermore, this study used the 0.5×SD formula to calculate MCIDdistribution. This formula indicates the clinical relevance to patients, and our value may be considered for use as a reference value (29). However, MCIDdistribution is influenced by the distribution of participant scores and does not address clinical importance; this disregards the aim of MCID to define clinical importance distinctly from statistical significance (30). Furthermore, it is reasonable that the MCID calculated using the anchor method, which is the minimal change of clinical significance, was larger than that calculated using the distribution method (29, 31). In this study, the MCIDadjust was 7.7 points (hand 2.0 points, side 3.7 points), which was larger than the MCIDdistribution of 3.4 points (hand 1.1 points, side 1.6 points). Additionally, these MCID values were approximately 6% of the total score for each CUE-T. The MCID of the Fugl-Meyer Assessment of the Upper Extremity, which is the gold standard for upper limb functional evaluation after stroke, is reported to be 6% of the total score (32). Therefore, we suggest that a clinically meaningful improvement was achieved when the CUE-T total score improved by 7.7 points or more at 1-month intervals.
In this study, the SCIM III was used as an external anchor. Conventionally, it is recommended to use patient-reported outcomes (PROs) when calculating the MCID to decide whether the patients have improved or worsened (16). PROs are determined subjectively using the global rating of change score (GRC), which consists of several stages (33). Notably, different methods using other scales can be used to calculate MCID, such as using ADL evaluations as the anchor (34). In this study, the external anchor was SCIM III, which is an ADL evaluation specialized for SCI. We found a significant correlation between the amount of change in the SCIM III, an external anchor, and the amount of change in the CUE-T (rs > 0.5). The results indicated that changes in SCIM III scores were more reflective of changes in CUE-T scores and met the criterion of a certain level of anchor for calculating clinically meaningful changes.
In addition, MCIDs were calculated for three groups: the group with only incomplete injuries, the group with an injury duration of less than 6 months, and the group aged <65 years. Next, we conducted a sensitivity analysis of the obtained MCID. The results showed that the maximum difference in the MCID between all the participants and the other groups was 1.0 points, indicating a minimal difference. Therefore, the MCID calculated in this study may be used regardless of complete or incomplete injuries, duration of injury, or age. However, the MCID was slightly higher in the group with incomplete injuries and the group aged <65 years. This result may be influenced by the difference in the recovery process between incomplete injuries, wherein functional recovery can be expected, and complete injuries, wherein functional recovery is poor (35). Furthermore, functional recovery is more likely in those aged <65 years compared to those aged >65 years, which may have influenced the results (36).
CSCI has a different recovery process depending on the difference between NLI and AIS. In this study, sensitivity analysis was performed for incomplete injuries, age, and duration of injury; however, the clinical setting differs between the injury level and AIS-C and AIS-D (35). In particular, there were many participants with NLI at C4 and C5, suggesting a bias in severity. It is necessary to calculate the MCID corresponding to various injuries in future studies.
Study limitations
The anchor used in this study was the SCIM III, which evaluates the ADL execution status. PROs such as GRC were previously recommended as anchors (15, 16). In this study, the data were collected at a single institution. The MCID values varied depending on the calculation method. Therefore, the participants of this study may not fully reflect the population. The various levels of NLI and AIS were mixed, and the severity of the disease varied. In addition, no blinding was implemented between the two data collections, which may have introduced measurement bias. It is necessary to reconsider the use of PROs as anchors, set detailed criteria for the inclusion of participants, and implement blinding in future studies.
Conclusions
In this study, we calculated the MCID of the CUE-T, which is an upper limb function evaluation specialized for CSCI. The calculated MCID may contribute to various areas such as clinical trials and clinical situations. Future studies should reconsider the evaluation as an anchor and calculate the MCID of the CUE-T with higher accuracy.
Acknowledgments
The authors would like to thank the staffs of the Chiba Rehabilitation Center for their cooperation in data collection and other activities. And, we would like to thank Editage (www.editage.com) for English language editing.
Appendix A: Flow diagram of this study data collection
Data collection and intervention flow for this study.
Appendix B: Participants for sensitivity analysis
| Incomplete | <6months | <65 years | ||
|---|---|---|---|---|
| n (male/female) | 38 (34/4) | 42 (36/6) | 31 (29/2) | |
| Age, years | 57.8 (11.3) | 56.4 (13.4) | 48.5 (11.0) | |
| Days from injury to baseline assessment, days | 85.7 (45.6) | 72.8 (32.3) | 92.7 (59.4) | |
| Days from injury to follow up assessment, days | 119.1 (47.8) | 106.0 (33.0) | 126.9 (61.6) | |
| AIS | A | 0 | 3 | 3 |
| B | 0 | 5 | 4 | |
| C | 14 | 13 | 7 | |
| D | 24 | 21 | 17 | |
| NLI | C1 | 1 | 1 | 1 |
| C2 | 0 | 0 | 0 | |
| C3 | 5 | 5 | 3 | |
| C4 | 13 | 15 | 13 | |
| C5 | 12 | 14 | 8 | |
| C6 | 1 | 1 | 2 | |
| C7 | 5 | 5 | 3 | |
| C8 | 1 | 1 | 1 | |
| Th1 | 0 | 0 | 0 | |
| CUE-T total baseline | 52.8 (31.6) | 45.6 (33.6) | 47.1 (33.7) | |
| CUE-T total follow up | 60.79 (32.9) | 52.8 (35.5) | 54.3 (36.1) | |
| CUE-T hand baseline | 13.4 (10.0) | 11.0 (10.5) | 11.6 (10.6) | |
| CUE-T hand follow up | 15.6 (10.4) | 12.9 (11.1) | 13.5 (11.3) | |
| CUE-T side baseline | 27.1 (14.7) | 23.3 (16.0) | 24.2 (16.2) | |
| CUE-T side follow up | 30.9 (15.0) | 26.8 (16.8) | 27.6 (16.8) | |
| SCIM III total baseline | 31.6 (27.7) | 26.7 (25.7) | 28.4 (25.5) | |
| SCIM III total follow up | 42.7 (29.3) | 37.2 (28.6) | 37.4 (28.4) | |
AIS, American Spinal Injury Association (ASIA) Impairment Scale; NLI, Neurological level of injury; CUE-T, Capabilities of Upper Extremity Test; SCIM, Spinal cord independence measure.
Appendix C: CUE-T MCID for sensitivity analysis
| CUE-Ttotal | CUE-Thand | CUE-Tside | ||
|---|---|---|---|---|
| Incomplete | MCIDadjust | 8.3 | 2.2 | 4.0 |
| MCIDdistribution | 3.5 | 1.2 | 1.6 | |
| < 6 months | MCIDadjust | 7.6 | 1.9 | 3.7 |
| MCIDdistribution | 3.5 | 1.1 | 1.6 | |
| < 65 years | MCIDadjust | 8.7 | 2.3 | 4.0 |
| MCIDdistribution | 3.4 | 1.2 | 1.6 |
CUE-T, Capabilities of Upper Extremity Test; MCID, minimal clinically important difference.
Disclaimer statements
Contributors None.
Funding None.
Conflicts of interest Authors have no conflict of interests to declare.
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