Clinical trial NCT02117089: Upper Limb Rehabilitation After Stroke Assisted With a Hybrid Electrical Stimulation (ES)-Robot System
Official title: Biomechatronic System Using Voluntary Motor Effort (VME)-Driven Neuromuscular Electrical Stimulation (NMES) for Upper Limb Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2014-04-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the combined training effectiveness of mechanical robot and neuromuscular electrical stimulation on upper limb rehabilitation after stroke.


Eligibility criteria: Inclusion Criteria:

The recruited subjects will

* have unilateral ischemic brain injury or intracerebral hemorrhage at least 6 months after the onset of single stroke
* have moderate level of motor impairment in the affected upper limb, assessed by Fugl-Meyer Assessment (9\<shoulder/elbow\<27; 6\<wrist/hand\<18)
* have enough cognition to be able to follow the training protocol as assessed by Mini-metal State Examination (MMSE\>21)
* have detectable EMG signals (3 times of the standard deviation above the baseline) from the upper limb muscles.

Primary outcomes:
measure: Change in Fugl-Meyer Assessment Scale after training
timeFrame: 1) up to 7 weeks, 2) 3 months after participants finish the training
measure: Change in Modified Ashworth Scale after training
timeFrame: 1) up to 7 weeks, 2) 3 months after participants finish the training
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Xiaoling Hu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guo Z, Zhou S, Ji K, Zhuang Y, Song J, Nam C, Hu X, Zheng Y. Corticomuscular integrated representation of voluntary motor effort in robotic control for wrist-hand rehabilitation after stroke. J Neural Eng. 2022 Mar 9;19(2). doi: 10.1088/1741-2552/ac5757.
citation: Ye F, Yang B, Nam C, Xie Y, Chen F, Hu X. A Data-Driven Investigation on Surface Electromyography Based Clinical Assessment in Chronic Stroke. Front Neurorobot. 2021 Jul 15;15:648855. doi: 10.3389/fnbot.2021.648855. eCollection 2021.
citation: Qian Q, Nam C, Guo Z, Huang Y, Hu X, Ng SC, Zheng Y, Poon W. Distal versus proximal - an investigation on different supportive strategies by robots for upper limb rehabilitation after stroke: a randomized controlled trial. J Neuroeng Rehabil. 2019 Jun 3;16(1):64. doi: 10.1186/s12984-019-0537-5.
citation: Nam C, Rong W, Li W, Xie Y, Hu X, Zheng Y. The Effects of Upper-Limb Training Assisted with an Electromyography-Driven Neuromuscular Electrical Stimulation Robotic Hand on Chronic Stroke. Front Neurol. 2017 Dec 14;8:679. doi: 10.3389/fneur.2017.00679. eCollection 2017.
citation: Qian Q, Hu X, Lai Q, Ng SC, Zheng Y, Poon W. Early Stroke Rehabilitation of the Upper Limb Assisted with an Electromyography-Driven Neuromuscular Electrical Stimulation-Robotic Arm. Front Neurol. 2017 Sep 4;8:447. doi: 10.3389/fneur.2017.00447. eCollection 2017.
citation: Rong W, Li W, Pang M, Hu J, Wei X, Yang B, Wai H, Zheng X, Hu X. A Neuromuscular Electrical Stimulation (NMES) and robot hybrid system for multi-joint coordinated upper limb rehabilitation after stroke. J Neuroeng Rehabil. 2017 Apr 26;14(1):34. doi: 10.1186/s12984-017-0245-y.