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. 2020 Sep 28;10(9):e039650. doi: 10.1136/bmjopen-2020-039650

Table 3.

Summary of the analysis for each objective, outcome and corresponding hypothesis

Variable/outcome Hypothesis Outcome measure (type of outcome) Methods of analysis
1. Primary

  • Upper extremity function.

 FES intervention (I) is better than conventional therapy control (C). SCIM-SC subscale score. ANCOVA.
2. Secondary

  • Limb function.

 I is better than C. SCIM mobility subscale score. ANCOVA.

  • Upper limb function.

 I is better than C. GRASSP subscales:
Strength total score.
Sensibility total score.
Qualitative prehension total score.
Quantitative prehension total score.		 ANCOVA.

  • Upper limb function.

 I is better than C. TRI-HFT subscales:
Object manipulation score.
Wooden block score.
Cylinder torque.
Credit card force.
Wooden bar displacement length.		 ANCOVA.

  • QoL.

 I is better than C. SCI-QOL subscales:
Basic mobility score.
Fine motor score.
Manual wheelchair score.
Power wheelchair score.
Self-care score.
Independence score.
Pain behaviour score.
Pain interference score.
Satisfaction with social roles and activities score.		 ANCOVA.

  • Safety.

 I is better than C. Serious and non-serious adverse events, total number of each per group. Descriptive.

  • Healthcare resource utilisation.

 Reduced healthcare resource utilisation with I compared with C. Healthcare resource utilisation questionnaire, total number of minutes. ANCOVA.
3. Sensitivity analyses:

  • Per-protocol.

  • Missing data based imputed based on LOCF.

  • Adjusted analysis with key baseline characteristics: age, baseline function and QoL.

 Results of analysis of primary analysis will remain robust. SCIM-SC score. ANCOVA with multivariable analysis for adjusted analysis.
Important remarks:

  • In all analyses, results will be expressed as coefficient, SEs, corresponding 95% and associated p values.

  • Goodness-of-fit will be assessed by examining the residuals for model assumptions and χ2 test of goodness-of-fit.

ANCOVA, analysis of covariance; C, control; FES, functional electrical stimulation; GRASSP, Graded Redefined Assessment of Strength, Sensibility and Prehension; I, intervention; LOCF, last observation carried forward; QOL, quality of life; SCIM, Spinal Cord Independence Measure III; SCIM-SC, Spinal Cord Independence Measure III self-care sub-scale; SCI-QOL, Spinal Cord Injury-Quality of Life; TRI-HFT, Toronto Rehab Institute Hand Function Test.