StrokeNCT04721561
Towards Understanding Upper Limb Rehabilitation After Stroke
An observational study of Stroke, run by KU Leuven at 1 site in Belgium.
Trial summary
After a stroke, more than two out of three patients experience problems with upper limb movement and sensation. During the past decade, robotic technology has been increasingly used to asses these problems in a detailed and accurate manner. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 44 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Dec 2019to 22 Dec 2020
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All participants will be recruited from the community sample.
Who may be able to join
- At least 18 years old
- A first-ever unilateral, supratentorial stroke (as defined by WHO)
- In the chronic phase after stroke (i.e. being at least 6 months after stroke)
- The ability to perform, at least to some extent, active shoulder abduction and wrist extension against gravity
- At least 18 years old
Who cannot join
- Any serious musculoskeletal and/or other neurological conditions
- Serious communication or cognitive deficits
- No written informed consent
- History of stroke or TIA
- Upper limb somatosensory and/or motor impairments
- Any serious musculoskeletal and/or other neurological conditions
- Serious communication or cognitive deficits
- No written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Robotic Assessment of Upper Limb Passive and Active Sensory Processing in the Chronic Phase After Stroke
After a stroke, more than two out of three patients experience problems with upper limb movement and sensation. During the past decade, robotic technology has been increasingly used to asses these problems in a detailed and accurate manner. However, sensory processing, one of the most important sensory functions, has not been assessed using robotic technology yet. Therefore, the investigators have developed a robotic assessment of sensory processing. During this study, the investigators aim to initially validate this novel assessment. The investigators aim to examine 20 chronic stroke patients and 20 age-matched healthy controls using the robotic assessment on one hand, and a set of existing clinical assessments on the other hand. The investigators hypothesize that stroke patients will have a poorer performance on this novel robotic assessment compared to age-matched healthy controls, and that these findings are similar to what is found with existing clinical assessments.
Read the detailed description
Up to 70% of stroke survivors show upper limb impairments consisting of motor and/or somatosensory impairments. These impairments often persist well into the chronic stage, and may lead to significant limitations in activities of daily living and may negatively affect quality of life. It is therefore of utmost importance to accurately assess upper limb impairments. Clinical assessments exist for both motor and somatosensory function, but lack good psychometric properties. Robotic technology show promising potential and is readily available to assess motor function and proprioception. Robotic assessment for sensory processing is currently not yet available, despite being the most relevant somatosensory function. Indeed, sensory processing shows the strongest association with upper limb movement, and only shows incomplete recovery at 6 months after stroke.
The investigators recently developed a novel robotic assessment of sensory processing, using the Kinarm End-Point Lab (BKIN Technologies Ltd., Canada). This cross-sectional study was set up to initially validate this novel robotic assessment and to collect pilot data to form the basis for future research. 20 chronic stroke patients and 20 age-matched controls will be recruited and will undergo extensive clinical and robotic assessment of upper limb motor and somatosensory function. The investigators hypothesize stoke patients with sensory processing deficits to have a worse performance on this novel robotic assessment compared to healthy controls and patients without sensory processing deficits. The investigators also hypothesize to see moderate to high correlations between the robotic assessment of sensory processing, and clinical assessments for both somatosensory and motor function.
- Conditions
- Stroke
- Keywords
- Stroke, Upper limb, Somatosensation, Sensory processing, Robotic assessment, Kinematics
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic stroke patients | Patients who are at least 6 months after a first unilateral stroke | |
| Healthy controls | Healthy subjects with no history of any neurological condition and who are in the same age group as the chronic stroke patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinarm: sensory processing task
Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing
Measured: Once in the chronic phase (at least 6 months after stroke)
Secondary outcomes (13)
Kinarm: position matching task
Assessment of limb position sense using a 9-target mirror-matching task on the Kinarm End-Point Lab
Measured: Once in the chronic phase (at least 6 months after stroke)
Kinarm: visually guided reaching
Assessment of motor function using a 4-target centre-out reaching task on the Kinarm End-Point Lab
Measured: Once in the chronic phase (at least 6 months after stroke)
Erasmus modified Nottingham sensory assessment
Clinical assessment of sensory processing with an area under the curve based scoring system, with higher scores meaning better performance
Measured: Once in the chronic phase (at least 6 months after stroke)
Tactile discrimination test
Clinical assessment of sensory processing with an area under the curve based scoring system, with higher scores meaning better performance
Measured: Once in the chronic phase (at least 6 months after stroke)
Tactile functional object recognition
Clinical assessment of sensory processing on an ordinal scale ranging from 0 to 42, with higher scores meaning better performance
Measured: Once in the chronic phase (at least 6 months after stroke)
Stereognosis section of the original Nottingham sensory assessment
Clinical assessment of sensory processing on an ordinal scale ranging from 0 to 22, with higher scores meaning better performance
Measured: Once in the chronic phase (at least 6 months after stroke)
Wrist position sense test
Clinical assessment of wrist position sense on a continuous scale, with lower scores meaning better performance
Measured: Once in the chronic phase (at least 6 months after stroke)
Perceptual threshold of touch
TENS-based assessment of exteroception on a continuous scale, with lower scores meaning better performance
Measured: Once in the chronic phase (at least 6 months after stroke)
Fugl-Meyer upper extremity assessment
Clinical assessment of motor function on an ordinal scale ranging from 0 to 66, with higher scores meaning better performance
Measured: Once in the chronic phase (at least 6 months after stroke)
Action research arm test
Clinical assessment of motor activity performance on an ordinal scale ranging from 0 to 57, with higher scores meaning better performance
Measured: Once in the chronic phase (at least 6 months after stroke)
Barthel index
Clinical assessment of activities of daily living on an ordinal scale ranging from 0 to 20, with higher scores meaning better performance
Measured: Once in the chronic phase (at least 6 months after stroke)
Montreal cognitive assessment
Clinical assessment of cognitive function on an ordinal scale ranging from 0 to 30, with higher scores meaning better performance
Measured: Once in the chronic phase (at least 6 months after stroke)
Star cancellation test
Clinical assessment of visuospatial neglect on an ordinal scale ranging from 0 to 54, with higher scores meaning better performance, and a score below 44 indicating the presence of visuospatial neglect
Measured: Once in the chronic phase (at least 6 months after stroke)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start18 Dec 2019
- Primary completion22 Dec 2020
- Study completion22 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Prof Geert Verheyden, KU Leuven
- Investigators
- Geert Verheyden, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721561
- Sponsor's protocol ID
- S61997
- Other IDs
- C22/18/008
- Status last verified
- Mar 2023
- First submitted
- 19 Jan 2021
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Saenen L, De Bruyn N, Verheyden G. Validity of a sensorimotor adaptation of the Action Research Arm Test (sARAT) in chronic stroke. Disabil Rehabil. 2024 Sep;46(19):4532-4539. doi: 10.1080/09638288.2023.2271837. Epub 2023 Oct 23.
PubMed 37872776
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Assessment of Upper Limb Passive and Active Sensory Processing in the Chronic Phase After Stroke
- ClinicalTrials.gov ID
- NCT04721561
- Acronym / sponsor ID
- S61997
- Conditions
- Stroke
- Keywords
- Stroke, Upper limb, Somatosensation, Sensory processing, Robotic assessment, Kinematics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 22 Jan 2021 (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.
After a stroke, more than two out of three patients experience problems with upper limb movement and sensation. During the past decade, robotic technology has been increasingly used to asses these problems in a detailed and accurate manner. However, sensory processing, one of the most important sensory functions, has not been assessed using robotic technology yet. Therefore, the investigators have developed a robotic assessment of sensory processing. During this study, the investigators aim to initially validate this novel assessment. The investigators aim to examine 20 chronic stroke patients and 20 age-matched healthy controls using the robotic assessment on one hand, and a set of existing clinical assessments on the other hand. The investigators hypothesize that stroke patients will have a poorer performance on this novel robotic assessment compared to age-matched healthy controls, and that these findings are similar to what is found with existing clinical assessments.
Detailed description
Up to 70% of stroke survivors show upper limb impairments consisting of motor and/or somatosensory impairments. These impairments often persist well into the chronic stage, and may lead to significant limitations in activities of daily living and may negatively affect quality of life. It is therefore of utmost importance to accurately assess upper limb impairments. Clinical assessments exist for both motor and somatosensory function, but lack good psychometric properties. Robotic technology show promising potential and is readily available to assess motor function and proprioception. Robotic assessment for sensory processing is currently not yet available, despite being the most relevant somatosensory function. Indeed, sensory processing shows the strongest association with upper limb movement, and only shows incomplete recovery at 6 months after stroke.
The investigators recently developed a novel robotic assessment of sensory processing, using the Kinarm End-Point Lab (BKIN Technologies Ltd., Canada). This cross-sectional study was set up to initially validate this novel robotic assessment and to collect pilot data to form the basis for future research. 20 chronic stroke patients and 20 age-matched controls will be recruited and will undergo extensive clinical and robotic assessment of upper limb motor and somatosensory function. The investigators hypothesize stoke patients with sensory processing deficits to have a worse performance on this novel robotic assessment compared to healthy controls and patients without sensory processing deficits. The investigators also hypothesize to see moderate to high correlations between the robotic assessment of sensory processing, and clinical assessments for both somatosensory and motor function.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic stroke patients | – | –Patients who are at least 6 months after a first unilateral stroke |
| Healthy controls | – | –Healthy subjects with no history of any neurological condition and who are in the same age group as the chronic stroke patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All participants will be recruited from the community sample.
Key inclusion criteria (5 listed)
- At least 18 years old
- A first-ever unilateral, supratentorial stroke (as defined by WHO)
- In the chronic phase after stroke (i.e. being at least 6 months after stroke)
- The ability to perform, at least to some extent, active shoulder abduction and wrist extension against gravity
- At least 18 years old
Key exclusion criteria (8 listed)
- Any serious musculoskeletal and/or other neurological conditions
- Serious communication or cognitive deficits
- No written informed consent
- History of stroke or TIA
- Upper limb somatosensory and/or motor impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Kinarm: sensory processing task
Time frame: Once in the chronic phase (at least 6 months after stroke)
Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing
13 secondary outcomes
Kinarm: position matching task
Time frame: Once in the chronic phase (at least 6 months after stroke)
Kinarm: visually guided reaching
Time frame: Once in the chronic phase (at least 6 months after stroke)
Erasmus modified Nottingham sensory assessment
Time frame: Once in the chronic phase (at least 6 months after stroke)
Tactile discrimination test
Time frame: Once in the chronic phase (at least 6 months after stroke)
Tactile functional object recognition
Time frame: Once in the chronic phase (at least 6 months after stroke)
Stereognosis section of the original Nottingham sensory assessment
Time frame: Once in the chronic phase (at least 6 months after stroke)
Wrist position sense test
Time frame: Once in the chronic phase (at least 6 months after stroke)
Perceptual threshold of touch
Time frame: Once in the chronic phase (at least 6 months after stroke)
Fugl-Meyer upper extremity assessment
Time frame: Once in the chronic phase (at least 6 months after stroke)
Action research arm test
Time frame: Once in the chronic phase (at least 6 months after stroke)
Barthel index
Time frame: Once in the chronic phase (at least 6 months after stroke)
Montreal cognitive assessment
Time frame: Once in the chronic phase (at least 6 months after stroke)
Star cancellation test
Time frame: Once in the chronic phase (at least 6 months after stroke)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Derived from this study: PubMed 37872776Saenen L, De Bruyn N, Verheyden G. Validity of a sensorimotor adaptation of the Action Research Arm Test (sARAT) in chronic stroke. Disabil Rehabil. 2024 Sep;46(19):4532-4539. doi: 10.1080/09638288.2023.2271837. Epub 2023 Oct 23.
- Individual participant dataSharing planned: Undecided
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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.
Geert Verheyden principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by KU Leuven 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 29 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinarm: sensory processing task (time frame: Once in the chronic phase (at least 6 months after stroke)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04721561, which also lists 1 linked publication.
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 29 Mar 2023.