StrokeARTHENCT01723046
Therapeutic Effects of a New Upper Limb Robot Assisted Therapy Device for Persons After Stroke
A study testing Training with new upper limb robot assisted therapy device in people with Stroke, run by Thomas More Kempen at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Training with new upper limb robot assisted therapy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who are medically unstable
- Cognitive disorders impeding the intervention
- Visual disorders impeding the intervention
- Subluxation of the shoulder joint
- Pusher syndrome
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Thomas More Kempen
Geel, Antwepen, 2440
Lore Van de Perre, MSc, +32 14 56 23 10, lore.van.de.perre@khk.be
Peter Karsmakers, PhD, +32 14 56 23 10, peter.karsmakers@khk.be
About this study
Official title: Active Smart Wearable Orthosis Using Painted EMG Electrodes for Home Based Therapy With Augmentative Feedback
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Training with new upper limb robot assisted therapy device
- Keywords
- Upper extremity, Rehabilitation, Robot assisted therapy, Robotics, Devices, Orthosis, clinical outcome
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training with new upper limb robot assisted therapy deviceDevice
Also called active orthosis, exoskeleton
During 8 weeks, 3 times a week, 1 hour therapy sessions with the device
| Study group | Role | What they receive |
|---|---|---|
| Training with the device | Experimental | Training with new upper limb robot assisted therapy device Receives: Device: Training with new upper limb robot assisted therapy device |
| Control group | No intervention | The control group is treated with conventional therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer test upper limb section
Stroke specific, performance based impairment index. Applied to determine disease severity and describe motor recovery.
Measured: Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks
Medical research council score
Muscle strength assessment
Measured: Change from baseline Medical research council score at 8 weeks and 12 weeks
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
Measured: Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks
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.
Measured: Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks
Modified Ashworth Scale
Spasticity measurement
Measured: Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks
Secondary outcomes (4)
ABILHAND questionnaire
Questionnaire-based assessment of manual ability
Measured: Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks
Functional independence measure
Assessment of physical and cognitive disability, focusing on the burden of care.
Measured: Change from baseline Functional independence measure score at 8 weeks and 12 weeks
Stroke impact scale
Questionnaire evaluating how stroke has impacted the person's health and life.
Measured: Change from baseline Stroke impact scale score at 8 weeks and 12 weeks
Intrinsic motivation inventory
Multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments.
Measured: Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startFeb 2013
- Primary completionJul 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas More Kempen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lore Van de Perre, Thomas More Kempen
- Investigators
- Lore Van de Perre, MSc, Principal investigator, Thomas More Kempen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723046
- Sponsor's protocol ID
- IWT120278
- Acronym
- ARTHE
- Status last verified
- Dec 2012
- First submitted
- 30 Oct 2012
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Smart Wearable Orthosis Using Painted EMG Electrodes for Home Based Therapy With Augmentative Feedback
- ClinicalTrials.gov ID
- NCT01723046
- Acronym / sponsor ID
- ARTHE / IWT120278
- Conditions
- Stroke
- Keywords
- Upper extremity, Rehabilitation, Robot assisted therapy, Robotics, Devices, Orthosis, clinical outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Thomas More KempenUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 7 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training with the device | Experimental | Device: Training with new upper limb robot assisted therapy deviceTraining with new upper limb robot assisted therapy device |
| Control group | No intervention | –The control group is treated with conventional therapy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Patients who are medically unstable
- Cognitive disorders impeding the intervention
- Visual disorders impeding the intervention
- Subluxation of the shoulder joint
- Pusher syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training with new upper limb robot assisted therapy deviceAlso: active orthosis, exoskeletonDuring 8 weeks, 3 times a week, 1 hour therapy sessions with the device | Device | Training with the device |
Primary outcome
Fugl-Meyer test upper limb section
Time frame: Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks
Stroke specific, performance based impairment index. Applied to determine disease severity and describe motor recovery.
Medical research council score
Time frame: Change from baseline Medical research council score at 8 weeks and 12 weeks
Muscle strength assessment
Active range of motion of the elbow joint
Time frame: Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks
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
Time frame: Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks
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
Time frame: Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks
Spasticity measurement
4 secondary outcomes
ABILHAND questionnaire
Time frame: Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks
Functional independence measure
Time frame: Change from baseline Functional independence measure score at 8 weeks and 12 weeks
Stroke impact scale
Time frame: Change from baseline Stroke impact scale score at 8 weeks and 12 weeks
Intrinsic motivation inventory
Time frame: Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2012.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lore Van de Perre, MSc principal investigator
Thomas More Kempen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training with new upper limb robot assisted therapy device in people with Stroke, run by Thomas More Kempen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lore Van de Perre, MSc (+32 14 56 23 10, lore.van.de.perre@khk.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer test upper limb section (time frame: Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2012.