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

NCT04502264 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-03-19

No results posted yet for this study

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.

Conditions

  • Chronic Stroke
  • Spasticity as Sequela of Stroke
  • Robotic Rehabilitation

Interventions

DEVICE

Hand of Hope

A virtual reality (VR)-based, electromyography (EMG)-driven, and task-oriented hand robot.

DRUG

Botulinum toxin type A injection

A safe agent representing the gold standard treatment for focal spasticity.

Sponsors & Collaborators

  • Cheng-Hsin General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-09
Primary Completion
2024-02-09
Completion
2024-02-09

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04502264 on ClinicalTrials.gov