Multi-center, single-blind randomized controlled trial comparing functional electrical stimulation therapy to conventional therapy in incomplete tetraplegia.
Multi-center, single-blind randomized controlled trial comparing functional electrical stimulation therapy to conventional therapy in incomplete tetraplegia.
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DOI：
10.3389/fresc.2022.995244
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发表时间：
2022
期刊：
影响因子：
--
通讯作者：
Thabane, Lehana
中科院分区：
文献类型：
--
作者：
Anderson, Kim D.;Korupolu, Radha;Musselman, Kristin E.;Pierce, Jacqueline;Wilson, James R.;Yozbatiran, Nuray;Desai, Naaz;Popovic, Milos R.;Thabane, Lehana
四肢瘫痪后上肢功能丧失会导致严重残疾。初步研究的新证据表明，功能性电刺激（FES）治疗可促进四肢瘫痪后上肢功能的恢复。本试验的目的是确定Myndmove刺激器提供的FES治疗对四肢瘫痪患者的有效性。进行了一项多中心、单盲、平行组、两组、随机对照试验，在损伤后4至96个月内患有C4-C7创伤性不完全性四肢瘫痪且基线脊髓损伤独立性测量III -自我护理（SCIM III-SC）评分≤10的成人（≥18岁）中比较FES与常规治疗。参与者在美国和加拿大的四个SCI专业神经康复中心注册。参与者按中心分层，并以1：1的比例随机接受40次FES或针对上肢的常规治疗，为期14周。设盲评估者在基线、第20次治疗后、第40次治疗后或第1次治疗后14周以及第1次治疗后24周测量SCIM III、多伦多康复研究所手功能测试和力量、感觉和知觉的分级重新定义评估。主要结局指标为SCIM III-SC从基线至治疗结束的变化。根据主要结局指标，计算样本量为60。17名参与者的研究进展因COVID-19封锁而中断。为这些受试者修改了方案，以允许他们完成研究。在2019年6月至2021年8月期间，51名参与者被随机分配到FES（n = 27）和常规治疗（n = 24）。治疗结束时，两组SCIM-SC评分平均增加2分，这是一个具有临床意义的变化。然而，两组之间的任何结局均无统计学显著差异。由MyndMove刺激器提供的40次FES治疗在产生有意义的功能改善方面与传统治疗一样有效，并且在治疗完成后持续存在。本研究的局限性包括COVID-19的影响限制了招募目标样本量的能力，以及在三分之一的参与者中按方案执行研究。本试验注册于www.ClinicalTrials.gov，NCT 03439319。
Loss of upper extremity function after tetraplegia results in significant disability. Emerging evidence from pilot studies suggests that functional electrical stimulation (FES) therapy may enhance recovery of upper extremity function after tetraplegia. The aim of this trial was to determine the effectiveness of FES therapy delivered by the Myndmove stimulator in people with tetraplegia. A multi-center, single-blind, parallel-group, two-arm, randomized controlled trial was conducted comparing FES to conventional therapy in adults (≥18 years) with C4–C7 traumatic incomplete tetraplegia between 4 and 96 months post-injury, and with a baseline spinal cord injury independence measure III -self-care (SCIM III-SC) score of ≤10. Participants were enrolled at four SCI-specialized neurorehabilitation centers in the U.S. and Canada. Participants were stratified by center and randomized in a 1:1 ratio to receive either 40 sessions of FES or conventional therapy targeting upper extremities over a 14-week period. Blinded assessors measured SCIM III, Toronto Rehabilitation Institute Hand Function Test, and Graded Redefined Assessment of Strength, Sensibility, and Prehension at baseline, after 20th session, after 40th session or 14 weeks after 1st session, and at 24 weeks after 1st session. The primary outcome measure was change in SCIM III-SC from baseline to end of the treatment. Based on the primary outcome measure, a sample size of 60 was calculated. Seventeen participants' progress in the study was interrupted due to the COVID-19 lockdown. The protocol was modified for these participants to allow them to complete the study. Between June 2019 to August 2021, 51 participants were randomized to FES (n = 27) and conventional therapy (n = 24). Both groups gained a mean of 2 points in SCIM-SC scores at the end of treatment, which was a clinically meaningful change. However, there was no statistically significant difference between the groups on any outcomes. Forty sessions of FES therapy delivered by the MyndMove stimulator are as effective as conventional therapy in producing meaningful functional improvements that persist after therapy is completed. Limitations of this study include the impact of COVID-19 limiting the ability to recruit the target sample size and per-protocol execution of the study in one-third of the participants. This trial is registered at www.ClinicalTrials.gov, NCT03439319.
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影响因子：
2.2
作者：
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DOI：
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作者：
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