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

NCT02117089 | Unknown DMC

• 1 other identifier: ITS/033/12
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• Change in Fugl-Meyer Assessment Scale after training

  The Fugl-Meyer Assessment Scale for upper limb measures the voluntary motor function on the shoulder, the elbow, the wrist and hand. The full score ranges from 0 to 66. It can be further separated into two subscores, i.e., shoulder/elbow (0-42) and wrist/hand (0-24). The higher the score, the better is the related motor function.

  1) up to 7 weeks, 2) 3 months after participants finish the training

• Change in Modified Ashworth Scale after training

  The Modified Ashworth Scale measures the resistance of a joint during passive motion, which indicates the muscle spasticity related to the joint motion, particularly the flexors. The Modified Ashworth Scale has six levels, i.e., 0, 1, 1+, 2, 3, 4. The higher value is related to a higher joint resistance, i.e., higher muscle spasticity.

  1) up to 7 weeks, 2) 3 months after participants finish the training

Study Arms (1)

Device-assisted rehabilitation

EXPERIMENTAL

Device: Electrical Stimulation; Rehabilitation Robot

Interventions

Electrical Stimulation; Rehabilitation Robot 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.

Device-assisted rehabilitation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 35193124 DERIVED

• 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.

  PMID: 34335219 DERIVED

• 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.

  PMID: 31159822 DERIVED

• 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.

  PMID: 29312116 DERIVED

• 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.

  PMID: 28928706 DERIVED

• 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.

  PMID: 28446181 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Xiaoling Hu, Ph.D.

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 17, 2014
• Study Start: October 1, 2013
• Primary Completion: September 1, 2024
• Study Completion: July 1, 2025
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

CN (1)