Effects of EMG-driven Robot-assisted Therapy for the Distal Upper Limb

Status Completed

Clinical Trial Summary

Over fifty percent of stroke patients experience chronic arm hand performance problems, compromising independence in daily life activities and quality of life. Traditionally, the effectiveness of rehabilitation in improving functioning for stroke patients more than 6 months has not been proven. However, spontaneous neurological recovery reaches the plateau at 3~6 months later. Hand of Hope is a virtual reality (VR)-based, electromyography (EMG)-driven, and task-oriented hand robot. Otherwise, it needs patients to have active participation during the intervention which is critical for motor recovery after stroke. Robotic rehabilitation devices have the potential to deliver high-intensity, reproducible therapy. Robot-assisted task-oriented training had been proposed by several researchers, but the evidence of clinical effectiveness in highly functional chronic stroke patients is still lack. Spasticity is a common disorder which occurs following stroke. The prevalence of post-stroke spasticity can be as high as 46% in the chronic phase (over 3 months). Spasticity impacted activities of daily living, quality of life, pain, and functional impairments. Long-term spasticity may lead to tendon contracture and limb deformities. Botulinum toxin injection, which mostly used in chronic phase (over 6 months), had been proved to be a safe agent representing the gold standard treatment for focal spasticity, while avoiding systemic effects. But the effects of botulism toxin on functional ability are still unclear. Moreover, there is insufficient evidence on adjunctive therapies following botulism toxin. The purpose of the present study is to examine the effects of botulinum toxin injection combined with Hand of Hope and standard occupational therapy on upper extremity function, and compares the findings to those of amount-matched chronic stroke survivors who received only Botulinum toxin injection and standard occupational therapy.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04502264
Study type	Interventional
Source	Cheng-Hsin General Hospital
Contact
Status	Completed
Phase	Phase 2
Start date	January 9, 2020
Completion date	February 9, 2024

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See also
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Completed	`NCT03208634` - Rehabilitation Multi Sensory Room for Robot Assisted Functional Movements in Upper-limb Rehabilitation in Chronic Stroke	N/A
Completed	`NCT05183100` - Effects of Neurodynamics on Lower Extremity Spasticity - a Study in Chronic Stroke	N/A
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effects of EMG-driven Robot-assisted Therapy for the Distal Upper Limb Motor Function in the Chronic Stroke Patients With Botox Injections

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms