Schuster-Amft Corina, Kool Jan, Möller J Carsten, Schweinfurther Raoul, Ernst Markus J, Reicherzer Leah, Ziller Carina, Schwab Martin E, Wieser Simon, Wirz Markus
Research Department, Reha Rheinfelden, Rheinfelden, Switzerland.
School of Engineering and Computer Science, Bern University of Applied Sciences, Biel, Switzerland.
Pilot Feasibility Stud. 2022 Jul 5;8(1):139. doi: 10.1186/s40814-022-01086-0.
There is a need to provide highly repetitive and intensive therapy programs for patients after stroke to improve sensorimotor impairment. The employment of technology-assisted training may facilitate access to individualized rehabilitation of high intensity. The purpose of this study was to evaluate the safety and acceptance of a high-intensity technology-assisted training for patients after stroke in the subacute or chronic phase and to establish its feasibility for a subsequent randomized controlled trial.
A longitudinal, multi-center, single-group study was conducted in four rehabilitation clinics. Patients participated in a high-intensity 4-week technology-assisted trainings consisting of 3 to 5 training days per week and at least 5 training sessions per day with a duration of 45 min each. Feasibility was evaluated by examining recruitment, intervention-related outcomes (adherence, subjectively perceived effort and effectiveness, adverse events), patient-related outcomes, and efficiency gains. Secondary outcomes focused on all three domains of the International Classification of Functioning Disability and Health. Data were analyzed and presented in a descriptive manner.
In total, 14 patients after stroke were included. Participants exercised between 12 and 21 days and received between 28 and 82 (mean 46 ± 15) technology-assisted trainings during the study period, which corresponded to 2 to 7 daily interventions. Treatment was safe. No serious adverse events were reported. Minor adverse events were related to tiredness and exertion. From baseline to the end of the intervention, patients improved in several functional performance assessments of the upper and lower extremities. The efficiency gains of the trainings amounted to 10% to 58%, in particular for training of the whole body and for walking training in severely impaired patients.
Highly intensive technology-assisted training appears to be feasible for in- and outpatients in the subacute or chronic phase after stroke. Further clinical trials are warranted in order to define the most comprehensive approach to highly intensive technology-assisted training and to investigate its efficacy in patients with neurological disorders.
ClinicalTrials.gov Identifier: NCT03641651 at August 31st 2018.
中风后患者需要接受高度重复且密集的治疗方案,以改善感觉运动障碍。采用技术辅助训练可能有助于获得高强度的个性化康复治疗。本研究的目的是评估亚急性期或慢性期中风患者进行高强度技术辅助训练的安全性和可接受性,并确定其在后续随机对照试验中的可行性。
在四家康复诊所进行了一项纵向、多中心、单组研究。患者参加为期4周的高强度技术辅助训练,每周训练3至5天,每天至少训练5次,每次训练持续45分钟。通过检查招募情况、干预相关结果(依从性、主观感受的努力程度和有效性、不良事件)、患者相关结果以及效率提升情况来评估可行性。次要结果聚焦于《国际功能、残疾和健康分类》的所有三个领域。数据采用描述性方式进行分析和呈现。
总共纳入了14例中风后患者。在研究期间,参与者训练了12至21天,接受了28至82次(平均46±15次)技术辅助训练,相当于每天进行2至7次干预。治疗是安全的。未报告严重不良事件。轻微不良事件与疲劳和劳累有关。从基线到干预结束,患者在上下肢的多项功能表现评估中有所改善。训练的效率提升了10%至58%,特别是对于全身训练和严重受损患者的步行训练。
高强度技术辅助训练对于中风后亚急性期或慢性期的门诊和住院患者似乎是可行的。有必要进行进一步的临床试验,以确定高强度技术辅助训练的最全面方法,并研究其对神经疾病患者的疗效。
ClinicalTrials.gov标识符:2018年8月31日为NCT03641651。