Safety and efficacy of intensive task-specific training in people with recent spinal cord injury: a phase 3, pragmatic, randomised, assessor-blinded, superiority trial.

The primary outcome of Total Motor Score at 10 weeks showed no significant difference between the intervention and control groups.

• Mean Total Motor Score at 10 weeks was 78.76 (SD 17.34) for the control group and 78.36 (SD 17.00) for the intervention group.
• The mean between-group difference was 0.93 (95% CI -1.63 to 3.48; p=0.48).
• The Total Motor Score is based on the International Standards for the Neurological Classification of SCI, scored 0-100 points.
• Data were available for 216 (98%) of 220 participants at 10 weeks (107 in the intervention group and 109 in the control group).

The intervention consisted of 12 hours per week for 10 weeks of intensive task-specific training targeting voluntary motor function below the level of the lesion, supplemented with strength training, added to usual care.

• The intervention was delivered on top of usual inpatient rehabilitation care from a multi-disciplinary team.
• Training targeted motor function at and below the level of the lesion.
• The trial ran over 10 weeks duration.
• The study was designed as a phase 3 pragmatic superiority randomised controlled trial.

There were serious adverse events including two deaths in the intervention group.

• There were four serious adverse events in total: three in the intervention group and one in the control group.
• Two deaths occurred among participants from the intervention group.
• Serious adverse events were defined as those resulting in death, life-threatening conditions, prolongation of hospitalisation, or substantial disability.

The trial enrolled 220 participants with recent spinal cord injury across 15 hospitals in six countries.

• Participants were randomly assigned to control (n=111; 23 female and 88 male) or intervention (n=109; 28 female and 81 male) groups.
• Recruitment took place between June 7, 2021, and Feb 5, 2025.
• Hospitals were located in Australia, Belgium, Italy, the Netherlands, Norway, and the UK (England and Scotland).
• Eligibility required SCI sustained in the preceding 10 weeks, some motor function below the level of injury, and current inpatient rehabilitation.
• Randomisation was computer generated, concealed, and stratified by site and level of injury.

The trial was conducted based on the widely held belief that intensive task-specific training enhances neurological recovery in people with SCI by exploiting activity-dependent spinal plasticity.

• The hypothesis was that additional intensive training would improve recovery following recent SCI.
• The primary outcome was measured at 10 weeks post-randomisation.
• All analyses were conducted by intention to treat.
• Outcome assessors were blinded to group assignment.

Secondary clinical outcomes also showed no significant benefit from the intensive task-specific training intervention.

• The abstract states the intervention 'did not result in significant benefits on our primary and secondary clinical outcomes.'
• The evidence does not support any beneficial effect of additional training for those receiving usual inpatient rehabilitation care from a multi-disciplinary team.
• Specific secondary outcome data were not reported in the abstract.