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NCT Number: NCT02117089

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Fugl-Meyer Assessment Scale after training

    Time frame: 1) up to 7 weeks, 2) 3 months after participants finish the 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.

  2. Change in Modified Ashworth Scale after training

    Time frame: 1) up to 7 weeks, 2) 3 months after participants finish the 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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Biomechatronic System Using Voluntary Motor Effort (VME)-Driven Neuromuscular Electrical Stimulation (NMES) for Upper Limb Rehabilitation

Important dates

Study start
2013
Primary completion
2027
Study completion
2027
First posted
Apr 17, 2014
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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