StrokeARTHENCT03153254
Active Smart Wearable Orthosis for Enhanched Rehabilitation THErapy
A study testing Test upper limb robot assisted therapy device and Training with new upper limb robot assisted therapy device in people with Stroke, run by Thomas More Kempen at 4 sites in Belgium.
Trial summary
The purpose of this study is to investigate the usability of a new upper limb robot assisted therapy device in stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Test upper limb robot assisted therapy device and 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
- 20 participants
- Where
- 4 sitesBelgium
- Study dates
- 15 Sep 2017to 30 Sep 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Persons between 18 and 85 years old that can perform all sorts of daily activities with their upper limbs
- Ability to sit on a chair with adequate trunk stability
- Ability to follow verbal instructions
- Ability to communicate verbally with the researchers
- Stroke patients, more than three months after onset
- Aged between 18 and 85 years
Show all 11Show fewer
- None to moderate spasticity in the hemiplegic arm (Modified Ashworth Scale: 0-2)
- Detectable voluntary muscle activity at elbow flexion and elbow extension of the hemiplegic arm (Medical research council score: 1-5)
- Ability to sit on a chair with adequate trunk stability
- Ability to follow verbal instructions
- Ability to communicate verbally with the researchers
Who cannot join
- Ever had a fracture in the upper limbs
- Ever had a surgery in the upper limbs
- Pain in the upper limbs obstructing the execution of daily activities with the upper limbs
- Physical trauma in the two months preceding the research
- Mental problems that make the execution of daily activities unreliable
- (Chronic) subluxation of the shoulder joint
Show all 24Show fewer
- Secundary soft tissue problems which may complicate the research or make it impossible (e.g. shoulder impingement, musculoskeletal problems, sensory deficits)
- Pregnancy
- Pacemaker
- Known allergies for one of the components of the ARTHE rehabilitation tool
- Stroke patients:
- Stroke patients, less than three months after onset
- Massive spastic patterns
- Severe medical conditions that interfere with the proper execution of the research, patients who are medically unstable
- Cognitive disorders which may complicate the research or make it impossible
- Speaking disorders (aphasia, dysarthria) which may complicate the proper execution of the research and the communication of important verbal information
- Visual disorders which may complicate the research or make it impossible
- (Chronic) subluxation of the shoulder joint
- Shoulder-hand-syndrom
- Pusher syndrom
- Secundary soft tissue problems which may complicate the research or make it impossible (e.g. shoulder impingement, musculoskeletal problems, sensory deficits)
- Pregnancy
- Pacemaker
- Known allergies for one of the components of the ARTHE rehabilitation tool
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites, 2 recruiting
- Recruiting
RevArthe
Edegem, Antwerp, 2650
Christhophe Lafosse, Prof.
- Completed
Thomas More - Mobilab
Geel, Antwerp, 2440
- Active, not recruiting
REVAlution
Herentals, Antwerp, 2200
- Recruiting
Revalidatie & MS Centrum
Overpelt, Antwerp, 3900
Martine Verhoeven
About this study
Official title: Usability Study of an Active Smart Wearable Orthosis for Enhanched Rehabilitation Therapy in Stroke Patients
The purpose of this study is to investigate the usability of a new upper limb robot assisted therapy device in stroke patients.
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 usability of a new upper arm RAT device for upper arm rehabilitation in stroke patients is investigated. Myo-electrical signals will serve as input for the device, assisting the user in flexion and extension of the elbow, which is combined with a stabilizing shoulder brace and a bionic glove.
- Conditions
- Stroke
- Being tested
- Test upper limb robot assisted therapy device, Training with new upper limb robot assisted therapy device
- Keywords
- Upper extremity, Rehabilitation, Robot assisted therapy, Robotics, Devices, Orthosis
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test upper limb robot assisted therapy deviceDevice
Also called active orthosis, exoskeleton
During 1 session of 1/2 hour.
Training with new upper limb robot assisted therapy deviceDevice
Also called active orthosis, exoskeleton
During 2 to 5 sessions of 1/2 hour.
| Study group | Role | What they receive |
|---|---|---|
| Healthy persons | Experimental | Test upper limb robot assisted therapy device. During 1 session of 1/2 hour. Receives: Device: Test upper limb robot assisted therapy device |
| Stroke patients | Experimental | Training with new upper limb robot assisted therapy device. During 2 to 5 sessions of 1/2 hour. Receives: Device: Training with new upper limb robot assisted therapy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate user experience by a self-composed questionnaire.
Investigate user experience by a self-composed questionnaire with theorems where upon users have to score. Possible scores range from 1 (totally disagree) to 4 (totally agree).
Measured: Up to 30 minutes at the last session
Secondary outcomes (2)
Measure the rate of perceived exertion by the Borg scale.
Measure the rate of perceived exertion by the Borg scale. The Borg scale is a way of measuring physical activity intensity level. Possible scores range from 0 (no fatigue at all) to 10 (worst imaginable fatigue).
Measured: Up to 5 minutes at the last session
Investigate whether wearing the device improves functionality by the Action Research Arm Test (ARAT).
The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia.
Measured: Up to 5 weeks (at week 1, week 2 and week 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start15 Sep 2017
- Primary completion30 Sep 2018 (estimated)
- Study completion30 Sep 2018 (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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1: Healthy persons Phase 2: Stroke patients
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas More Kempen
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho-Medico
- Responsible party
- Principal investigator, Lieven De Maesschalck, Thomas More Kempen
- Investigators
- Lieven De Maesschalck, Principal investigator, Thomas More Kempen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153254
- Sponsor's protocol ID
- S60144
- Acronym
- ARTHE
- Status last verified
- Aug 2018
- First submitted
- 6 Mar 2017
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability Study of an Active Smart Wearable Orthosis for Enhanched Rehabilitation Therapy in Stroke Patients
- ClinicalTrials.gov ID
- NCT03153254
- Acronym / sponsor ID
- ARTHE / S60144
- Conditions
- Stroke
- Keywords
- Upper extremity, Rehabilitation, Robot assisted therapy, Robotics, Devices, Orthosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Thomas More KempenUniversity, hospital or other
- Collaborators
- Ortho-Medico
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 15 May 2017 (actual)
- 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 study is to investigate the usability of a new upper limb robot assisted therapy device in stroke patients.
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 usability of a new upper arm RAT device for upper arm rehabilitation in stroke patients is investigated. Myo-electrical signals will serve as input for the device, assisting the user in flexion and extension of the elbow, which is combined with a stabilizing shoulder brace and a bionic glove.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1: Healthy persons Phase 2: Stroke patients
| Arm | Type | Receives |
|---|---|---|
| Healthy persons | Experimental | Device: Test upper limb robot assisted therapy deviceTest upper limb robot assisted therapy device. During 1 session of 1/2 hour. |
| Stroke patients | Experimental | Device: Training with new upper limb robot assisted therapy deviceTraining with new upper limb robot assisted therapy device. During 2 to 5 sessions of 1/2 hour. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Stroke patients, more than three months after onset
- Aged between 18 and 85 years
- None to moderate spasticity in the hemiplegic arm (Modified Ashworth Scale: 0-2)
- Detectable voluntary muscle activity at elbow flexion and elbow extension of the hemiplegic arm (Medical research council score: 1-5)
- Ability to sit on a chair with adequate trunk stability
Key exclusion criteria (24 listed)
- Stroke patients:
- Stroke patients, less than three months after onset
- Massive spastic patterns
- Severe medical conditions that interfere with the proper execution of the research, patients who are medically unstable
- Cognitive disorders which may complicate the research or make it impossible
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 |
|---|---|---|
| Test upper limb robot assisted therapy deviceAlso: active orthosis, exoskeletonDuring 1 session of 1/2 hour. | Device | Healthy persons |
| Training with new upper limb robot assisted therapy deviceAlso: active orthosis, exoskeletonDuring 2 to 5 sessions of 1/2 hour. | Device | Stroke patients |
Primary outcome
Investigate user experience by a self-composed questionnaire.
Time frame: Up to 30 minutes at the last session
Investigate user experience by a self-composed questionnaire with theorems where upon users have to score. Possible scores range from 1 (totally disagree) to 4 (totally agree).
2 secondary outcomes
Measure the rate of perceived exertion by the Borg scale.
Time frame: Up to 5 minutes at the last session
Investigate whether wearing the device improves functionality by the Action Research Arm Test (ARAT).
Time frame: Up to 5 weeks (at week 1, week 2 and week 5)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Lieven De Maesschalck principal investigator
Thomas More Kempen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test upper limb robot assisted therapy device and Training with new upper limb robot assisted therapy device in people with Stroke, run by Thomas More Kempen at 4 sites 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 11 inclusion and 24 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 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Lieven De Maesschalck (014/56 23 10 ext. 32, lieven.demaesschalck@thomasmore.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate user experience by a self-composed questionnaire. (time frame: Up to 30 minutes at the last session). 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 21 Aug 2018.