Table 1.
Randomization of individuals with motor complete SCI using block randomization based on level of injury (paraplegia vs tetraplegia) and time since injury (less than or more than 10 years) into either NMES + FES or PM + FES
| Subject ID | Assignment | Baseline 1 | Post-intervention 1 | Post-intervention 2 |
|---|---|---|---|---|
| 001–10123 | PM + FES | C | C | C |
| 002–10187 | PM + FES | C | C | C |
| 003–10122 | NMES + FES | C | C | C |
| 004–10006 | NMES + FES | C | C | C |
| 005–10128 | NMES + FES | C | C | C |
| 006–10142 | PM + FES | C | C | X |
| 007–10179 | NMES + FES | C | C | C |
| 008 | N/A | X | X | X |
| 009–10135 | NMES + FES | C | Withdraw | X |
| 010–10177 | PM + FES | C | C | C |
| 011–10064 | PM + FES | C | C | C |
| 012–10181 | NMES+FES | C | C | C |
| 013–10026 | PM + FES | Withdraw | X | X |
| 014–10149 | NMES + FES | C | C | C |
| 015–10089 | NMES + FES | C | C | C |
| 016–10140 | PM + FES | C | C | C |
| 017–10178 | PM + FES | C | C | C |
| 018–10154 | PM + FES | C | C | C |
| 019–10034 | NMES + FES | C | C | C |
| 020–10176 | NMES + FES | C | C | C |
| 021–10163 | NMES + FES | Withdraw | X | X |
| 022–10130 | PM + FES | C | C | C |
| 023–10113 | PM + FES | C | C | Withdraw |
| 024–10186 | NMES + FES | C | C | C |
| 025 | N/A | x | x | X |
| 026–10097 | PM + FES | withdraw | x | X |
| 027–10148 | PM + FES | C | C | C |
| 028–10092 | NMES + FES | C | C | Withdraw |
| 029–10180 | NMES + FES | C | C | C |
| 030–10019 | PM + FES | C | C | C |
| 031 | N/A | x | x | X |
| 032–10160 | NMES + FES | C | C | X |
| 033–10052 | PM + FES | C | C | X |
| 034 | N/A | x | x | X |
| 035 | Pending randomization | |||
| 036 | TBR | |||
| 037 | TBR | |||
| 038 | TBR | |||
| 039 | TBR | |||
| 040 | TBR | |||
| 041 | TBR | |||
| 042 | TBR | |||
| 043 | TBR | |||
| 044 | TBR | |||
| 045 | TBR | |||
| 046 | TBR | |||
| 047 | TBR | |||
| 048 | TBR |
C completed, NA not assigned for #008, 025, and 031, TBR to be recruited later
Before baseline 1, randomization was performed into NMES + FES or PM + FES groups. Post-intervention 1 (n = 23) was conducted after 12 weeks of intervention of either NMES or PM. Post-intervention 2 (n = 20) was conducted after 12 weeks of FES