Benson Ian, Hart Kirsten, Tussler Dot, van Middendorp Joost J
National Spinal Injuries Centre, Stoke Mandeville Hospital, Buckinghamshire NHS Trust, Aylesbury, UK Stoke Mandeville Spinal Research, Stoke Mandeville Hospital, Aylesbury, UK.
National Spinal Injuries Centre, Stoke Mandeville Hospital, Buckinghamshire NHS Trust, Aylesbury, UK.
Clin Rehabil. 2016 Jan;30(1):73-84. doi: 10.1177/0269215515575166. Epub 2015 Mar 11.
To assess the feasibility of conducting a well-powered trial evaluating the neurological and functional effects of using an exoskeleton in individuals with chronic spinal cord injury.
A longitudinal, prospective, self-controlled feasibility study.
Specialist Spinal Cord Injuries Centre, UK; 8 months during 2013-2014.
Individuals with chronic motor complete or incomplete spinal cord injury.
Enrolled subjects were assigned to 20 exoskeleton (ReWalk™, Argo Medical Technologies Ltd, Yokneam Ilit, Israel) training sessions over a 10-week training period.
Feasibility measures, clinical and mobility outcome measures and measures appraising subjects' disability and attitude towards assistive technology were assessed before, during and after the study. Descriptive statistics were applied.
Out of 60 candidates, ten (17%) were enrolled and five (8%) completed the training programme. Primary reasons for not enrolling were ineligibility (n = 24, 40%) and limited interest to engage in a 10-week training programme (n = 16, 27%). Five out of ten enrolled subjects experienced grade I/II skin aberrations. While walking speeds were higher and walking distances were longer in all exoskeleton users when compared with non-use, the exoskeleton did generally not meet subjects' high expectations in terms of perceived benefits.
The conduct of a controlled trial evaluating the benefits of using exoskeletons that require a lengthy user-commitment to training of individuals with chronic motor complete or incomplete spinal cord injury comes with considerable feasibility challenges. Vigilance is required for preventing and detecting medical complications in spinal cord injury exoskeleton users.
评估开展一项效能充分的试验的可行性，该试验旨在评估使用外骨骼对慢性脊髓损伤患者神经和功能方面的影响。
一项纵向、前瞻性、自身对照的可行性研究。
英国专业脊髓损伤中心；2013年至2014年期间的8个月。
慢性运动完全性或不完全性脊髓损伤患者。
入选的受试者在为期10周的训练期间接受20次外骨骼（ReWalk™，阿戈医疗技术有限公司，以色列约克尼阿姆伊利特）训练课程。
在研究前、研究期间和研究后评估可行性指标、临床和移动性结果指标，以及评估受试者残疾情况和对辅助技术态度的指标。采用描述性统计方法。
60名候选者中，10名（17%）入选，5名（8%）完成了训练计划。未入选的主要原因是不符合条件（n = 24，40%）和对参与为期10周的训练计划兴趣有限（n = 16，27%）。10名入选受试者中有5名出现了I/II级皮肤异常。与不使用外骨骼相比，所有使用外骨骼的受试者行走速度更高，行走距离更长，但外骨骼在感知益处方面总体上未达到受试者的高期望。
开展一项对照试验来评估使用外骨骼的益处面临相当大的可行性挑战，这类试验要求慢性运动完全性或不完全性脊髓损伤患者长期投入训练。对于预防和检测脊髓损伤外骨骼使用者的医学并发症需要保持警惕。
