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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02117089
Enrollment
48
Registered
2014-04-17
Start date
2013-10-31
Completion date
2025-07-31
Last updated
2024-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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.

Interventions

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.

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Fugl-Meyer Assessment Scale after training1) up to 7 weeks, 2) 3 months after participants finish the trainingThe 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.
Change in Modified Ashworth Scale after training1) up to 7 weeks, 2) 3 months after participants finish the trainingThe 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026