Institute of Psychiatry and Neuroscience of Paris, INSERM U1266, Université Paris Cité, 102-108 Rue de La Santé, 75014, Paris, France.
Service de Médecine Physique et de Réadaptation, Groupe Hospitalier Universitaire Paris, Psychiatrie et Neurosciences, 1 Rue Cabanis, 75014, Paris, France.
J Neuroeng Rehabil. 2023 Jul 18;20(1):93. doi: 10.1186/s12984-023-01213-9.
To compare the efficacy of Dextrain Manipulandum™ training of dexterity components such as force control and independent finger movements, to dose-matched conventional therapy (CT) post-stroke.
A prospective, single-blind, pilot randomized clinical trial was conducted. Chronic-phase post-stroke patients with mild-to-moderate dexterity impairment (Box and Block Test (BBT) > 1) received 12 sessions of Dextrain or CT. Blinded measures were obtained before and after training and at 3-months follow-up. Primary outcome was BBT-change (after-before training). Secondary outcomes included changes in motor impairments, activity limitations and dexterity components. Corticospinal excitability and short intracortical inhibition (SICI) were measured using transcranial magnetic stimulation.
BBT-change after training did not differ between the Dextrain (N = 21) vs CT group (N = 21) (median [IQR] = 5[2-7] vs 4[2-7], respectively; P = 0.36). Gains in BBT were maintained at the 3-month post-training follow-up, with a non-significant trend for enhanced BBT-change in the Dextrain group (median [IQR] = 3[- 1-7.0], P = 0.06). Several secondary outcomes showed significantly larger changes in the Dextrain group: finger tracking precision (mean ± SD = 0.3 ± 0.3N vs - 0.1 ± 0.33N; P < 0.0018), independent finger movements (34.7 ± 25.1 ms vs 7.7 ± 18.5 ms, P = 0.02) and maximal finger tapping speed (8.4 ± 7.1 vs 4.5 ± 4.9, P = 0.045). At follow-up, Dextrain group showed significantly greater improvement in Motor Activity Log (median/IQR = 0.7/0.2-0.8 vs 0.2/0.1-0.6, P = 0.05). Across both groups SICI increased in patients with greater BBT-change (Rho = 0.80, P = 0.006). Comparing Dextrain subgroups with maximal grip force higher/lower than median (61.2%), BBT-change was significantly larger in patients with low vs high grip force (7.5 ± 5.6 vs 2.9 ± 2.8; respectively, P = 0.015).
Although immediate improvements in gross dexterity post-stroke did not significantly differ between Dextrain training and CT, our findings suggest that Dextrain enhances recovery of several dexterity components and reported hand-use, particularly when motor impairment is moderate (low initial grip force). Findings need to be confirmed in a larger trial. Trial registration ClinicalTrials.gov NCT03934073 (retrospectively registered).
比较 DexTrain 操纵杆训练在力量控制和独立手指运动等灵巧性成分方面的疗效，与剂量匹配的常规疗法（CT）相比，用于治疗脑卒中后患者。
这是一项前瞻性、单盲、随机临床试验。患有轻度至中度灵巧性障碍（Box and Block 测试（BBT）＞1）的慢性期脑卒中患者接受 12 次 DexTrain 或 CT 治疗。在训练前后和 3 个月随访时进行盲法评估。主要结局为 BBT 变化（训练后-训练前）。次要结局包括运动障碍、活动受限和灵巧性成分的变化。使用经颅磁刺激测量皮质脊髓兴奋性和短程内抑制（SICI）。
DexTrain 组（N=21）与 CT 组（N=21）在训练后 BBT 变化无差异（中位数[IQR]分别为 5[2-7]和 4[2-7]；P=0.36）。在 3 个月的训练后随访中，BBT 获益得以维持，DexTrain 组 BBT 变化有增强的趋势，但无统计学意义（中位数[IQR]为 3[-1-7.0]，P=0.06）。几个次要结局显示 DexTrain 组的变化明显更大：手指跟踪精度（平均值±标准差为 0.3±0.3N 与-0.1±0.33N；P＜0.0018）、独立手指运动（34.7±25.1ms 与 7.7±18.5ms，P=0.02）和最大手指敲击速度（8.4±7.1 与 4.5±4.9，P=0.045）。在随访时，DexTrain 组在运动活动日志（中位数/IQR 为 0.7/0.2-0.8 与 0.2/0.1-0.6，P=0.05）方面显示出显著更大的改善。在两组患者中，BBT 变化较大的患者 SICI 增加（Rho=0.80，P=0.006）。将 DexTrain 亚组的最大握力分为高于/低于中位数（61.2%），低握力患者的 BBT 变化明显大于高握力患者（7.5±5.6 与 2.9±2.8；P=0.015）。
尽管脑卒中后即刻粗大灵巧性改善在 DexTrain 训练和 CT 之间无显著差异，但我们的发现表明 DexTrain 增强了多种灵巧性成分和手部使用的恢复，尤其是在运动障碍程度中等（初始握力较低）时。需要更大的试验来证实这些发现。试验注册：ClinicalTrials.gov NCT03934073（前瞻性注册）。
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