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

Cheng-Hsin General Hospital

Status and phase: Completed; Phase 2

Conditions: Spasticity as Sequela of Stroke; Chronic Stroke; Robotic Rehabilitation

Treatments: Drug: Botulinum toxin type A injection; Device: Hand of Hope

Study type: Interventional

Funder types: Other

Identifiers

NCT04502264

(745)108A-61

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged between 20-85 year-old
• The onset of stroke must be at least 6 month previously
• The stroke must be the first event
• The stroke must be unilateral brain lesion
• Spasticity measured as Modified Ashworth scale during 1+ to 3
• Score at least 1 point in the wrist subtest of Fugl-Meyer Assessment
• Brunnstrom stage of proximal upper limb at least 3, distal upper limb between 2 to 5
• No impairment in visual tracking ability
• No impairment in proprioception

Exclusion criteria

• Severe joints pain of hand or finger at affected limb
• Fracture of affected limb in three months
• Brunnstrom stage of proximal upper limb not more than 2, distal upper limb more than 5

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

Botulinum toxin, hand robot training, occupational therapy

Experimental group

Description:

Patient would receive Botulinum toxin (Injections of 100\~400U of Botox in the upper limb muscle with a 2ml/100U dilution), robot-assisted therapy (Hand of Hope training), and standard occupational therapy.

Treatment:

Drug: Botulinum toxin type A injection

Device: Hand of Hope

Botulinum toxin, occupational therapy

Active Comparator group

Description:

Patient would receive Botulinum toxin (Injections of 100\~400U of Botox in the upper limb muscle with a 2ml/100U dilution) and standard occupational therapy.

Treatment:

Drug: Botulinum toxin type A injection