Upper Limb Rehabilitation After Stroke Assisted With a Hybrid Electrical Stimulation (ES)-Robot System

NCT ID: NCT02117089

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Device-assisted rehabilitation

Group Type EXPERIMENTAL

Electrical Stimulation; Rehabilitation Robot

Intervention Type DEVICE

The recruited subjects will receive 20-session device assisted upper limb training with an intensity of 3 to 5 sessions/week, which will be finished within 7 consecutive weeks. In each session, the subjects will conduct the system assisted and task-oriented upper limb training for 1.5 hours.

Interventions

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Electrical Stimulation; Rehabilitation Robot

The recruited subjects will receive 20-session device assisted upper limb training with an intensity of 3 to 5 sessions/week, which will be finished within 7 consecutive weeks. In each session, the subjects will conduct the system assisted and task-oriented upper limb training for 1.5 hours.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Xiaoling Hu

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaoling Hu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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The Hong Kong Polytechnic University

Hong Kong, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Xiaoling Hu, Ph.D.

Role: primary

+852 34003205

References

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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.

Reference Type DERIVED
PMID: 35193124 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34335219 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31159822 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29312116 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28928706 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28446181 (View on PubMed)

Other Identifiers

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ITS/033/12

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ITS/033/12

Identifier Type: -

Identifier Source: org_study_id

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