Anderson Kim D, Korupolu Radha, Musselman Kristin E, Pierce Jacqueline, Wilson James R, Yozbatiran Nuray, Desai Naaz, Popovic Milos R, Thabane Lehana
MetroHealth Rehabilitation Institute, MetroHealth System, Cleveland, OH, United States.
Department of Physical Medicine and Rehabilitation, Case Western Reserve University School of Medicine, Cleveland, OH, United States.
Front Rehabil Sci. 2022 Sep 9;3:995244. doi: 10.3389/fresc.2022.995244. eCollection 2022.
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 ( = 27) and conventional therapy ( = 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.
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）疗法可能会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疗法对四肢瘫痪患者的有效性。
进行了一项多中心单盲、平行组、双臂随机对照试验，将FES与传统疗法进行比较，研究对象为年龄≥18岁、C4 - C7创伤性不完全性四肢瘫痪且受伤后4至96个月、脊髓损伤独立测量III -自我护理（SCIM III - SC）基线评分≤10的成年人。参与者在美国和加拿大的四个脊髓损伤专科神经康复中心入组。参与者按中心分层，以1:1的比例随机接受为期14周的40次FES或针对上肢的传统疗法。盲法评估者在基线、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以及力量、感觉和抓握能力的分级重新评估。主要结局指标是从基线到治疗结束时SCIM III - SC的变化。根据主要结局指标，计算出样本量为60。由于COVID - 19封锁，17名参与者的研究进展中断。针对这些参与者修改了方案，以便他们完成研究。
在2019年6月至2021年8月期间，51名参与者被随机分配接受FES（n = 27）和传统疗法（n = 24）。两组在治疗结束时SCIM - SC评分平均提高了2分，这是一个具有临床意义的变化。然而，两组在任何结局指标上均无统计学显著差异。
MyndMove刺激器提供的40次FES疗法在产生有意义的功能改善方面与传统疗法一样有效，且这些改善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，以及三分之一的参与者未按方案执行研究。
