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

We aimed to determine whether 10 weeks of intensive task-specific training supplemented with strength training that targets motor function at and below the level of the lesion improves recovery following recent SCI.

我们的目标是确定在最近的脊髓损伤（SCI）后，为期10周的密集任务特异性训练，辅以针对损伤水平及以下的运动功能的力量训练，是否能改善恢复情况。

Methods

We conducted a pragmatic phase 3 superiority randomised controlled trialat 15 hospitals in Australia, Belgium, Italy, the Netherlands, Norway, and the UK (England and Scotland).

我们在澳大利亚、比利时、意大利、荷兰、挪威以及英国（英格兰和苏格兰）的15家医院进行了一项实用的第3阶段优势随机对照试验。

People who sustained a SCI in the preceding 10 weeks, had some motor function below the level of injury, and were receiving inpatient rehabilitation were randomly assigned to usual care (control group) or usual care plus 12 h per week for 10 weeks of intensive task-specific training targeting voluntary motor function below the level of the lesion supplemented with strength training (intervention group).

在过去10周内遭受脊髓损伤（SCI）、在损伤水平以下仍保留部分运动功能，并正在接受住院康复治疗的患者，被随机分配到常规护理组（对照组）或常规护理加上每周12小时、持续10周的针对损伤水平以下的自愿运动功能的强化任务特异性训练，并辅以力量训练（干预组）。

Randomisation was computer generated, concealed, and stratified by site and level of injury.

随机化是通过计算机生成的，隐藏的，并且根据地点和受伤程度进行了分层。

The primary outcome was Total Motor Score of the International Standards for the Neurological Classification of SCI (0-100 points) at 10 weeks.

主要结果是10周时脊髓损伤国际神经分类标准的总运动评分（0-100分）

The outcome assessors were blinded to group assignment.

结果评估者对分组分配情况不知情。

Serious adverse events were defined as those resulting in death, life-threatening conditions, prolongation of hospitalisation, or substantial disability.

严重的不良事件被定义为导致死亡、危及生命、延长住院时间或造成重大残疾的事件。

All analyses were conducted by intention to treat.

所有分析均按意向治疗原则进行。

The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12621000091808; universal trial number: U1111-1264-1689).

该试验已在澳大利亚新西兰临床试验注册处注册（ACTRN12621000091808；通用试验编号：U1111-1264-1689）。

Results

Between June 7, 2021, and Feb 5, 2025, 220 participants were randomly assigned to the control (n=111; 23 female and 88 male) or intervention (n=109; 28 female and 81 male) group.

在2021年6月7日至2025年2月5日期间，220名参与者被随机分配到对照组(n=111；女性23人，男性88人)或干预组(n=109；女性28人，男性81人)。

Data were available for 216 (98%) of 220 participants at 10 weeks (107 in the intervention group and 109 in the control group).

在10周时，220名参与者中有216名（98%）的数据可用（干预组107人，对照组109人）。

The mean Total Motor Scores at 10 weeks were 78·76 (SD 17·34) for the control group and 78·36 (SD 17·00) for the intervention group.

10周时，对照组的平均总运动评分为78.76（标准差17.34），干预组为78.36（标准差17.00）。

The mean between-group difference was 0·93 (95% CI -1·63 to 3·48; p=0·48).

两组之间的平均差异为0.93（95%置信区间-1.63至3.48；p=0.48）。

There were four serious adverse events (three in the intervention group and one in the control group) including two deaths in participants from the intervention group.

在参与者中发生了四起严重不良事件（干预组三起，对照组一起），包括干预组中两名参与者的死亡。

interpretation

Intensive task-specific training supplemented with strength training provided in people with recent SCI did not result in significant benefits on our primary and secondary clinical outcomes.

对于近期脊髓损伤患者，补充力量训练的密集特定任务训练并未在我们的主要和次要临床结果上带来显著益处。

The evidence does not support any beneficial effect of additional training for those receiving usual inpatient rehabilitation care from a multi-disciplinary team.

现有证据并不支持对那些接受常规多学科团队住院康复护理的患者进行额外培训有任何益处。

funding

New South Wales Ministry of Health, University of Sydney, and Wings for Life.

新南威尔士州卫生部、悉尼大学和Wings for Life。