Clinical trial NCT04502264: Effects of EMG-driven Robot-assisted Therapy for the Distal Upper Limb Motor Function in the Chronic Stroke Patients With Botox Injections
Official title: Effects of EMG-driven Robot-assisted Therapy for the Distal Upper Limb Motor Function in the Chronic Stroke Patients With Botox Injections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Stroke
Spasticity as Sequela of Stroke
Robotic Rehabilitation
Keywords: Hand of hope
hand robot
Botulinum toxin
Lead sponsor: Cheng-Hsin General Hospital
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: modified Ashworth scale
timeFrame: 14 weeks
measure: H-reflex
timeFrame: 14 weeks
measure: Box & Block Test
timeFrame: 14 weeks
measure: Nine Hole Peg Test
timeFrame: 14 weeks
measure: World Health Organization Quality of Life (WHOQOL-BREF)-Taiwan version
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Cheng-Hsin general hospital
Study officials:
References: