PDF(Pubmed)
Abstract：
OBJECTIVE: Soft robotic exoskeletons (SREs) are portable, lightweight assistive technology with therapeutic potential for improving lower limb motor function in children with cerebral palsy. To understand the effects of long-term SRE-assisted walking training on children with spastic cerebral palsy (SCP), we designed a study aiming to elucidate the effects of SRE-assisted walking training on lower limb motor function in this population.
METHODS: In this randomized, single-blinded (outcome assessor) controlled trial, forty children diagnosed with SCP were randomized into the routine rehabilitation (RR) group (N = 20) and the SRE group (N = 20) for comparison. The RR group received routine rehabilitation training, and the SRE group received routine rehabilitation training combined with SRE-assisted overground walking training. Assessments (without SRE) were conducted pre- and post-intervention (8 weeks after the intervention). The primary outcome measures included the 10 m walk test (10MWT) and the 6 min walk test (6MWT). Secondary outcome measures comprised the gross motor function measure-88, pediatric balance scale modified Ashworth scale, and physiological cost index.
RESULTS: Both groups showed significant improvements (p < 0.01) across all outcome measures after the 8-week intervention. Between-group comparisons using ANCOVA revealed that the SRE group demonstrated greater improvement in walking speed from the 10MWT (+6.78 m/min, 95% CI [5.74-7.83]; p < 0.001) and walking distance during the 6MWT (+34.42 m, 95% CI [28.84-39.99]; p < 0.001). The SRE group showed greater improvement in all secondary outcome measures (p < 0.001).
CONCLUSIONS: The study findings suggested that the integration of SRE-assisted overground walking training with routine rehabilitation more effectively enhances lower limb motor function in children with SCP compared to routine rehabilitation alone.
METHODS: In this randomized, single-blinded (outcome assessor) controlled trial, forty children diagnosed with SCP were randomized into the routine rehabilitation (RR) group (N = 20) and the SRE group (N = 20) for comparison. The RR group received routine rehabilitation training, and the SRE group received routine rehabilitation training combined with SRE-assisted overground walking training. Assessments (without SRE) were conducted pre- and post-intervention (8 weeks after the intervention). The primary outcome measures included the 10 m walk test (10MWT) and the 6 min walk test (6MWT). Secondary outcome measures comprised the gross motor function measure-88, pediatric balance scale modified Ashworth scale, and physiological cost index.
RESULTS: Both groups showed significant improvements (p < 0.01) across all outcome measures after the 8-week intervention. Between-group comparisons using ANCOVA revealed that the SRE group demonstrated greater improvement in walking speed from the 10MWT (+6.78 m/min, 95% CI [5.74-7.83]; p < 0.001) and walking distance during the 6MWT (+34.42 m, 95% CI [28.84-39.99]; p < 0.001). The SRE group showed greater improvement in all secondary outcome measures (p < 0.001).
CONCLUSIONS: The study findings suggested that the integration of SRE-assisted overground walking training with routine rehabilitation more effectively enhances lower limb motor function in children with SCP compared to routine rehabilitation alone.
摘要：
目的：软机器人外骨骼（SRE）是便携式的，具有改善脑瘫儿童下肢运动功能的治疗潜力的轻量级辅助技术。了解长期SRE辅助步行训练对痉挛型脑瘫（SCP）儿童的影响。我们设计了一项研究,旨在阐明SRE辅助步行训练对该人群下肢运动功能的影响.
方法：在本随机分组中，单盲（结果评估者）对照试验，40名被诊断为SCP的儿童被随机分为常规康复（RR）组（N=20）和SRE组（N=20）进行比较。RR组接受常规康复训练,SRE组接受常规康复训练联合SRE辅助地面步行训练。在干预前和干预后（干预后8周）进行评估（无SRE）。主要结果指标包括10m步行测试（10MWT）和6min步行测试（6MWT）。次要结局指标包括粗大运动功能测量88，儿科平衡量表改良的Ashworth量表，和生理成本指数。
结果：在8周的干预后，两组在所有结果指标中均显示出显着改善（p<0.01）。使用ANCOVA进行的组间比较显示，SRE组的步行速度从10MWT（6.78m/min，95%CI[5.74-7.83]；p<0.001)和6MWT期间的步行距离(+34.42m，95%CI[28.84-39.99]；p<0.001)。SRE组在所有次要结局指标中均显示出更大的改善（p<0.001）。
结论：研究结果表明，与单独的常规康复相比，SRE辅助的地面步行训练与常规康复相结合可以更有效地增强SCP患儿的下肢运动功能。
方法：在本随机分组中，单盲（结果评估者）对照试验，40名被诊断为SCP的儿童被随机分为常规康复（RR）组（N=20）和SRE组（N=20）进行比较。RR组接受常规康复训练,SRE组接受常规康复训练联合SRE辅助地面步行训练。在干预前和干预后（干预后8周）进行评估（无SRE）。主要结果指标包括10m步行测试（10MWT）和6min步行测试（6MWT）。次要结局指标包括粗大运动功能测量88，儿科平衡量表改良的Ashworth量表，和生理成本指数。
结果：在8周的干预后，两组在所有结果指标中均显示出显着改善（p<0.01）。使用ANCOVA进行的组间比较显示，SRE组的步行速度从10MWT（6.78m/min，95%CI[5.74-7.83]；p<0.001)和6MWT期间的步行距离(+34.42m，95%CI[28.84-39.99]；p<0.001)。SRE组在所有次要结局指标中均显示出更大的改善（p<0.001）。
结论：研究结果表明，与单独的常规康复相比，SRE辅助的地面步行训练与常规康复相结合可以更有效地增强SCP患儿的下肢运动功能。
