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

NCT ID: NCT04502264

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-09
• Study Completion Date: 2024-02-09

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Botulinum toxin, hand robot training, occupational therapy

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.

Group Type: EXPERIMENTAL

Hand of Hope

Intervention Type: DEVICE

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

Botulinum toxin type A injection

Intervention Type: DRUG

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

Botulinum toxin, occupational therapy

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.

Group Type: ACTIVE_COMPARATOR

Botulinum toxin type A injection

Intervention Type: DRUG

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

Interventions

Hand of Hope

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

Intervention Type: DEVICE

Botulinum toxin type A injection

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cheng-Hsin General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cheng-Hsin general hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

(745)108A-61

Identifier Type: -

Identifier Source: org_study_id