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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

Primary Purpose

Chronic Stroke, Spasticity as Sequela of Stroke, Robotic Rehabilitation

Status
Recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Hand of Hope
Botulinum toxin type A injection
Sponsored by
Cheng-Hsin General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stroke focused on measuring Hand of hope, hand robot, Botulinum toxin

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cheng-Hsin general hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Botulinum toxin, hand robot training, occupational therapy

Botulinum toxin, occupational therapy

Arm 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.

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.

Outcomes

Primary Outcome Measures

modified Ashworth scale
Modified Ashworth scale is a scale for spasticity evaluation, while 0 means no spasticity, 1 means slight increase in muscle tone, 1+ means more muscle tone than score equels 1, 2 means more marked muscle tone, 3 means passive movement is difficult, and 4 means rigidity. We would record modified Ashworth scale at upper limb of the hemiplegic patients.
H-reflex
H-reflex is a method of electricophysilogic evaluation for spasticity in nerve conduction study, while decreased latency means stronger muscle tone and prolonged latency means weaker muscle tone. H-reflex of all limbs at these patients would be recorded.
Box & Block Test
The Box and Block Test (BBT) measures unilateral gross manual dexterity. 150 blocks is set up at the test box, and clients are scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds. Higher scores are indicative of better manual dexterity.
Nine Hole Peg Test
The Nine-Hole Peg Test is used to measure finger dexterity by asking the client to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible. Scores are based on the time taken to complete the test activity, recorded in seconds.
World Health Organization Quality of Life (WHOQOL-BREF)-Taiwan version
The World Health Organization Quality of Life (WHOQOL-BREF) is a 28-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (4 items), and environmental health (9 items); with another 2 items about general condition and overall quality of life. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. The higher scores equals better quality of life.

Secondary Outcome Measures

Full Information

First Posted
July 22, 2020
Last Updated
February 10, 2023
Sponsor
Cheng-Hsin General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04502264
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2020 (Actual)
Primary Completion Date
December 9, 2023 (Anticipated)
Study Completion Date
December 9, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cheng-Hsin General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke, Spasticity as Sequela of Stroke, Robotic Rehabilitation
Keywords
Hand of hope, hand robot, Botulinum toxin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Botulinum toxin, hand robot training, occupational therapy
Arm Type
Experimental
Arm 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.
Arm Title
Botulinum toxin, occupational therapy
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Hand of Hope
Intervention Description
A virtual reality (VR)-based, electromyography (EMG)-driven, and task-oriented hand robot.
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A injection
Intervention Description
A safe agent representing the gold standard treatment for focal spasticity.
Primary Outcome Measure Information:
Title
modified Ashworth scale
Description
Modified Ashworth scale is a scale for spasticity evaluation, while 0 means no spasticity, 1 means slight increase in muscle tone, 1+ means more muscle tone than score equels 1, 2 means more marked muscle tone, 3 means passive movement is difficult, and 4 means rigidity. We would record modified Ashworth scale at upper limb of the hemiplegic patients.
Time Frame
14 weeks
Title
H-reflex
Description
H-reflex is a method of electricophysilogic evaluation for spasticity in nerve conduction study, while decreased latency means stronger muscle tone and prolonged latency means weaker muscle tone. H-reflex of all limbs at these patients would be recorded.
Time Frame
14 weeks
Title
Box & Block Test
Description
The Box and Block Test (BBT) measures unilateral gross manual dexterity. 150 blocks is set up at the test box, and clients are scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds. Higher scores are indicative of better manual dexterity.
Time Frame
14 weeks
Title
Nine Hole Peg Test
Description
The Nine-Hole Peg Test is used to measure finger dexterity by asking the client to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible. Scores are based on the time taken to complete the test activity, recorded in seconds.
Time Frame
14 weeks
Title
World Health Organization Quality of Life (WHOQOL-BREF)-Taiwan version
Description
The World Health Organization Quality of Life (WHOQOL-BREF) is a 28-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (4 items), and environmental health (9 items); with another 2 items about general condition and overall quality of life. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. The higher scores equals better quality of life.
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Szu-Fu Chen
Phone
+886-2-28264400
Ext
3806
Email
szufuchen@yahoo.com.tw
Facility Information:
Facility Name
Cheng-Hsin general hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Szu-Fu Chen
Phone
+886-2-28264400
Ext
3806
Email
szufuchen@yahoo.com.tw

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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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

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