Back to resultsTherapeutic Effects of a New Upper Limb Robot Assisted Therapy Device for Persons After Stroke (ARTHE)
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Training with new upper limb robot assisted therapy device
Sponsored by
About this trial
This is an interventional supportive care trial for Stroke focused on measuring Upper extremity, Rehabilitation, Robot assisted therapy, Robotics, Devices, Orthosis, clinical outcome
Eligibility Criteria
Inclusion Criteria:
- Patients with stroke, more than three months post onset
- No or moderate spasticity in the upper limb (maximum score of 3 on Modified Ashworth Scale)
- Observable voluntary muscle activity in biceps and triceps muscle of the affected upper limb (minimal score of 1 on the Medical research council score)
- Able to sit on a chair with adequate trunk stability
- Able to follow verbal instructions
- Able to communicate verbal information to the researchers
Exclusion Criteria:
- Patients who are medically unstable
- Cognitive disorders impeding the intervention
- Visual disorders impeding the intervention
- Subluxation of the shoulder joint
- Pusher syndrome
Sites / Locations
- Thomas More Kempen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Training with the device
Control group
Arm Description
Training with new upper limb robot assisted therapy device
The control group is treated with conventional therapy.
Outcomes
Primary Outcome Measures
Fugl-Meyer test upper limb section
Stroke specific, performance based impairment index. Applied to determine disease severity and describe motor recovery.
Medical research council score
Muscle strength assessment
Active range of motion of the elbow joint
The maximum range of motion to flexion and extension of the elbow joint that the person can achieve independently
Passive range of motion of the elbow joint
The maximum range of motion to flexion and extension of the elbow joint of the test person that can be achieved by the assessor.
Modified Ashworth Scale
Spasticity measurement
Secondary Outcome Measures
ABILHAND questionnaire
Questionnaire-based assessment of manual ability
Functional independence measure
Assessment of physical and cognitive disability, focusing on the burden of care.
Stroke impact scale
Questionnaire evaluating how stroke has impacted the person's health and life.
Intrinsic motivation inventory
Multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01723046
Brief Title
Therapeutic Effects of a New Upper Limb Robot Assisted Therapy Device for Persons After Stroke
Acronym
ARTHE
Official Title
Active Smart Wearable Orthosis Using Painted EMG Electrodes for Home Based Therapy With Augmentative Feedback
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thomas More Kempen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this pilot study is to investigate the clinical effects of a new upper limb robot assisted therapy device that is linked to a virtual therapy environment in patients with stroke.
Detailed Description
The number of physically weak individuals is increasing, resulting in a higher burden on health care and health care workers. The use of robot assisted therapy (RAT) might partly solve this problem. Rehabilitation progress highly depends on training intensity and training duration, favouring the use of RAT.
In this pilot study, the clinical effects of using a new upper arm RAT device for upper arm rehabilitation in patients with stroke is investigated. Myo-electrical signals will serve as input for the device, assisting the user in flexion and extension of the elbow. The device is coupled to a virtual environments, creating a stimulating therapy environment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Upper extremity, Rehabilitation, Robot assisted therapy, Robotics, Devices, Orthosis, clinical outcome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Training with the device
Arm Type
Experimental
Arm Description
Training with new upper limb robot assisted therapy device
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group is treated with conventional therapy.
Intervention Type
Device
Intervention Name(s)
Training with new upper limb robot assisted therapy device
Other Intervention Name(s)
active orthosis, exoskeleton
Intervention Description
During 8 weeks, 3 times a week, 1 hour therapy sessions with the device
Primary Outcome Measure Information:
Title
Fugl-Meyer test upper limb section
Description
Stroke specific, performance based impairment index. Applied to determine disease severity and describe motor recovery.
Time Frame
Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks
Title
Medical research council score
Description
Muscle strength assessment
Time Frame
Change from baseline Medical research council score at 8 weeks and 12 weeks
Title
Active range of motion of the elbow joint
Description
The maximum range of motion to flexion and extension of the elbow joint that the person can achieve independently
Time Frame
Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks
Title
Passive range of motion of the elbow joint
Description
The maximum range of motion to flexion and extension of the elbow joint of the test person that can be achieved by the assessor.
Time Frame
Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks
Title
Modified Ashworth Scale
Description
Spasticity measurement
Time Frame
Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks
Secondary Outcome Measure Information:
Title
ABILHAND questionnaire
Description
Questionnaire-based assessment of manual ability
Time Frame
Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks
Title
Functional independence measure
Description
Assessment of physical and cognitive disability, focusing on the burden of care.
Time Frame
Change from baseline Functional independence measure score at 8 weeks and 12 weeks
Title
Stroke impact scale
Description
Questionnaire evaluating how stroke has impacted the person's health and life.
Time Frame
Change from baseline Stroke impact scale score at 8 weeks and 12 weeks
Title
Intrinsic motivation inventory
Description
Multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments.
Time Frame
Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with stroke, more than three months post onset
No or moderate spasticity in the upper limb (maximum score of 3 on Modified Ashworth Scale)
Observable voluntary muscle activity in biceps and triceps muscle of the affected upper limb (minimal score of 1 on the Medical research council score)
Able to sit on a chair with adequate trunk stability
Able to follow verbal instructions
Able to communicate verbal information to the researchers
Exclusion Criteria:
Patients who are medically unstable
Cognitive disorders impeding the intervention
Visual disorders impeding the intervention
Subluxation of the shoulder joint
Pusher syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lore Van de Perre, MSc
Phone
+32 14 56 23 10
Email
lore.van.de.perre@khk.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lore Van de Perre, MSc
Organizational Affiliation
Thomas More Kempen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas More Kempen
City
Geel
State/Province
Antwepen
ZIP/Postal Code
2440
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lore Van de Perre, MSc
Phone
+32 14 56 23 10
Email
lore.van.de.perre@khk.be
First Name & Middle Initial & Last Name & Degree
Peter Karsmakers, PhD
Phone
+32 14 56 23 10
Email
peter.karsmakers@khk.be
First Name & Middle Initial & Last Name & Degree
Lore Van de Perre, MSc
First Name & Middle Initial & Last Name & Degree
Roy Sevit, MSc
First Name & Middle Initial & Last Name & Degree
Koen Janssens, MSc
First Name & Middle Initial & Last Name & Degree
Peter Karsmakers, PhD
First Name & Middle Initial & Last Name & Degree
Louis Peeraer, Prof.PhD
12. IPD Sharing Statement
Learn more about this trial
Therapeutic Effects of a New Upper Limb Robot Assisted Therapy Device for Persons After Stroke
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