論文

国際誌
2022年7月

Robot-Assisted Training as Self-Training for Upper-Limb Hemiplegia in Chronic Stroke: A Randomized Controlled Trial.

Stroke
  • Takashi Takebayashi
  • ,
  • Kayoko Takahashi
  • ,
  • Satoru Amano
  • ,
  • Masahiko Gosho
  • ,
  • Masahiro Sakai
  • ,
  • Koichi Hashimoto
  • ,
  • Kenji Hachisuka
  • ,
  • Yuki Uchiyama
  • ,
  • Kazuhisa Domen

53
7
開始ページ
2182
終了ページ
2191
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1161/STROKEAHA.121.037260
出版者・発行元
Ovid Technologies (Wolters Kluwer Health)

BACKGROUND:

This study aimed to examine whether robotic self-training improved upper-extremity function versus conventional self-training in mild-to-moderate hemiplegic chronic stroke patients.

METHODS:

Study design was a multi-center, prospective, randomized, parallel-group study comparing three therapist-guided interventions (1-hour sessions, 3×/wk, 10 weeks). We identified 161 prospective patients with chronic, poststroke, upper-limb hemiplegia treated at participating rehabilitation centers. Patients were enrolled between November 29, 2016, and November 12, 2018 in Japan. A blinded web-based allocation system was used to randomly assign 129 qualifying patients into 3 groups: (1) conventional self-training plus conventional therapy (control, N=42); (2) robotic self-training (ReoGo-J) plus conventional therapy (robotic therapy [RT], N=44); or (3) robotic self-training plus constraint-induced movement therapy (N=43). Primary outcome: Fugl-Meyer Assessment for upper-extremity. Secondary outcomes: Motor Activity Log-14 amount of use and quality of movement; Fugl-Meyer Assessment shoulder/elbow/forearm, wrist, finger, and coordination scores; Action Research Arm Test Score; Motricity Index; Modified Ashworth Scale; shoulder, elbow, forearm, wrist, and finger range of motion; and Stroke Impact Scale (the assessors were blinded). Safety outcomes were adverse events.

RESULTS:

Safety was assessed in 127 patients. An intention-to-treat full analysis set (N=121), and a per-protocol set (N=115) of patients who attended 80% of sessions were assessed. One severe adverse event was recorded, unrelated to the robotic device. No significant differences in Fugl-Meyer Assessment for upper-extremity scores were observed between groups (RT versus control: −1.04 [95% CI, −2.79 to 0.71], P =0.40; RT versus movement therapy: −0.33 [95% CI, −2.02 to 1.36], P =0.90). The RT in the per-protocol set improved significantly in the Fugl-Meyer Assessment for upper-extremity shoulder/elbow/forearm score (RT versus control: −1.46 [95% CI, −2.63 to −0.29]; P =0.037).

CONCLUSIONS:

Robotic self-training did not improve upper-limb function versus usual self-training, but may be effective combined with conventional therapy in some populations (per-protocol set).

REGISTRATION:

URL: https://www.umin.ac.jp/ctr ; Unique identifier: UMIN000022509.

リンク情報
DOI
https://doi.org/10.1161/STROKEAHA.121.037260
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/35345897
URL
https://www.ahajournals.org/doi/pdf/10.1161/STROKEAHA.121.037260
ID情報
  • DOI : 10.1161/STROKEAHA.121.037260
  • ISSN : 0039-2499
  • eISSN : 1524-4628
  • PubMed ID : 35345897

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