Chronic StrokeEarly Phase 1NCT05229185
Error-enhancement for Arm Rehabilitation Post Stroke
A Early Phase 1 study testing DeXtreme training (error-enhancement) in people with Chronic Stroke, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Even in a chronic phase after stroke, most patients have difficulty moving the affected arm, resulting in limitations in simple tasks in daily living, most frequently limiting reaching task. In the chronic phase, significant improvements are usually no longer observed. Read more about this study
- Who is it for?
- Ages Up to 85 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- DeXtreme training (error-enhancement)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Jan 2022to 23 Nov 2022
- Phase
- Early Phase 1
- 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 Up to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- First stroke, confirmed by neurologist based on clinical and/or imaging findings
- Ischemic/hemorrhagic stroke, at least more than six months ago
- Stroke affecting the dominant/non-dominant upper limb (unilateral weakness)
- Less than 85 years old
- Having a motor impairment yet no severe spasticity in the upper limb: be able to open and close the hand 5 times and be able to flex and extend the elbow 2 times but score less than 66 (maximum) on the Fugl-Meyer Assessment.
Who cannot join
- Having sensory aphasia (evaluated by item 9 of the National Institutes of Health Stroke Scale)
- Having apraxia (evaluated by the apraxia screen of TULIA)
- Having neglect (evaluated by the Star Cancellation Test)
- Cognitive deficit with a score under 24 out of 30 on the Mini-mental State Examination
- Shoulder pain (yes/no)
- Providing no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Error-enhancement as Basis for Novel Upper Limb Rehabilitation in the Chronic Phase After Stroke: a 5-day Pre-post Intervention Study.
Even in a chronic phase after stroke, most patients have difficulty moving the affected arm, resulting in limitations in simple tasks in daily living, most frequently limiting reaching task. In the chronic phase, significant improvements are usually no longer observed. Nevertheless, even these patients can still improve their functional abilities due to exercise-dependent plasticity.
A new device was developed, the deXtreme robot, a rehabilitation device that offers error-enhancement approach during three-dimensional movements. The goal error-enhancement is to elicit better accuracy, stability, fluidity and range of motion during reaching. games are projected on a screen, requiring 3D active reaching movements. The duration of the study for a single participant will be 7 consecutive working days, including 1 day of pre-intervention assessment, 5 days of training and 1 day of post-intervention assessment. The overall aim of this project is to gain knowledge into the potential of error-enhancement robot training in patients with upper limb impairments in the chronic phase after stroke. Hypothesizing that the 5-day training will have a positive effect on both the robotic and clinical outcome measures.
Read the detailed description
The overall aim of this study is to gain knowledge into the potential of error-enhancement robot training in patients with upper limb impairments in the chronic phase after stroke. Error-enhancement is characterized as unexpected external perturbation forces acting upon the upper limb during a reaching movement, causing the upper limb to deflect from the reaching pathway, and this results in errors. If one allows for repetitive reaching performance with the same systematic perturbation forces, then a decrease in errors and improvement in movement performance is expected. The robot used for the training, the DeXtreme, is a CE marked rehabilitation device that offers this error-enhancement approach during three-dimensional movements.
The pilot study has a pre-post intervention design, recruiting 20 patients in the chronic phase after stroke. Error-enhancement treatment will be provided on day 2 to 6, i.e., for 5 consecutive days and will consist of facilitation of accuracy, range of movement, stability, and smoothness. Algorithms provide progression in terms of accuracy, range of movement, stability and smoothness, depending upon the performance of the patient.
The treatment will start with the installation of the patient and a warming up, followed by a first block of DeXtreme training. Then a short break is given followed by a short conventional therapy session. The content of the conventional therapy will involve active relaxation, focusing on stretching and (auto-)mobilisation. Afterwards, a second block of training with the DeXtreme follows, and it finishes with a cooling down. A therapist trained by the company will provide all assessment and training sessions. Training with the DeXtreme is additional to the conventional therapy the patient receives. Therefore, a diary of their conventional therapy sessions will be kept, and the content will be reviewed with the patient.
Advancements in upper limb motor function and activity will be evaluated through a triad of measurements including clinical and patient-reported outcomes, error-enhancement variables, and objective quantification of uni- and bimanual sensorimotor function by making use of the KINARM robotic manipulandum. These tests and questionnaires are administered on day 1 and day 7.
The aim of the study is to investigate whether patients with upper limb impairments in a chronic phase after stroke clinical and meaningful benefits from 5 hours DeXtreme training. In addition, it is examined whether improvements in the upper limb outcome is the result of restitution or compensation in the upper limb function.
In order to evaluate whether a randomized controlled trial is useful, the investigators will analyse the outcomes of our study twofold. (1) At group level, the investigators will calculate mean and standard deviation or median and interquartile range (based on whether data is normally distributed or not) and evaluate whether pre- to post-intervention scores for clinical, deXtreme and objective outcomes are significantly improved by means of Wilcoxon signed rank test (nonparametric), at a 0,05 significance level. Each p-value will be interpreted in a descriptive manner.
(2) At patient level, the investigators will evaluate how many patients (%) achieve a clinically significant improvement based on the therapy provided.
To see if the improvement might be explained by restitution or compensation, the association between the scores of the MAL-14 and the visually guided reaching task of the KINARM will be explored by Spearman correlations.
- Conditions
- Chronic Stroke
- Being tested
- DeXtreme training (error-enhancement)
- Keywords
- upper limb, neurorehabilitation, error-enhancement, robotic treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeXtreme training (error-enhancement)Device
15-20 min DeXtreme - 15 min conventional therapy - 15-20 min DeXtreme
| Study group | Role | What they receive |
|---|---|---|
| DeXtreme (Error-enhacement) | Experimental | Training (error-enhancement): 5 consecutive days, 1 hour per day Receives: Device: DeXtreme training (error-enhancement) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action research arm test
Evaluating UL functional ability, providing information whether improvement in impairment (FMA-UE) results in increased activity level. Internationally accepted outcome measure for stroke studies, and extensive experience available in the research group.
min-max: 0-57 (higher = better)
Measured: day 1(pre) - day 7 (post)
Fugl-Meyer motor assessment upper extremity
Evaluating UL motor impairment (shoulder, elbow, wrist, hand and fingers), ability to measure restoration of function due to improved quality of movement. Internationally accepted outcome measure for stroke studies, and extensive experience available in the research group.
min-max: 0-66 (higher = better)
Measured: day 1(pre) - day 7 (post)
Kinarm: visually guided reaching task
Assessment of motor function using a 4-target centre-out reaching task on the Kinarm End-Point Lab.
Measured: day 1(pre) - day 7 (post)
DeXtreme: reaching task - Market stand
Assessment of motor function using reaching tasks on the DeXtreme robot (range of motion and accuracy).
Measured: day 1(pre) - day 7 (post)
DeXtreme: reaching task - Alchemist
Assessment of motor function using reaching tasks on the DeXtreme robot (stability and smoothness).
Measured: day 1(pre) - day 7 (post)
Secondary outcomes (7)
Visual analogue scale (VAS) - Pain
A measurement instrument that tries to measure a characteristic that is believed to range across a continuum of values and cannot easily be directly measured. In this case, it is used to determine the pain in the shoulder region.
min-max: 0-100 (higher = worse)
Measured: day 1(pre) - day 7 (post); after treatment (day 2-5)
Motor assessment scale - tonus
A single item of the MAS, general tonus, intended to provide an estimate of muscle tone of the arm/hand on the affected side.
Min-max: 0-6 (4 = normal tone, > 4 = hyper tone; < 4 = hypo tone)
Measured: day 1(pre) - day 7 (post); after treatment (day 2-5)
Kinarm: sensory processing task
Newly-developed task on the Kinarm End-Point Lab used to assess passive and active sensory processing.
Measured: day 1(pre) - day 7 (post)
Motor assessment scale - upper limb
A performance-based scale to assess everyday upper limb motor functions, based on a task-oriented approach to evaluation that assesses performance of functional tasks.
min-max: 0 - 18 (higher = better)
Measured: day 1(pre) - day 7 (post)
Stroke impact scale - Hand
Evaluating perceived function and quality of life with stroke: perceived hand function, scoring difficulty of five manual activities using the most affected hand. Experience present in the research group.
min-max: 0-100 (higher = better)
Measured: day 1(pre) - day 7 (post)
Motor Activity Log - 14 items
Evaluating the amount of use and the quality of the movement of the more-affected arm during functional activities, through a structured interview (patient reported outcome).
min-max: 0-5 (higher = better)
Measured: day 1(pre) - day 7 (post)
Kinarm: arm position matching task
Assessment of limb position sense using a 9-target mirror-matching task on the Kinarm Exoskeleton Lab.
Measured: day 1(pre) - day 7 (post)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start25 Jan 2022
- Primary completion23 Nov 2022
- Study completion23 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study has a pre-post intervention design, recruiting 20 patients in the chronic phase after stroke. Pre- and post-intervention assessments are administered on day 1 and 7.The 5 days in between, all patients receive the same training with the robot, there is no control group.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, BioXtreme
- Responsible party
- Sponsor
- Investigators
- Geert Verheyden, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229185
- Sponsor's protocol ID
- s65699
- Status last verified
- Feb 2022
- First submitted
- 24 Dec 2021
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim RK, Kang N. Bimanual Coordination Functions between Paretic and Nonparetic Arms: A Systematic Review and Meta-analysis. J Stroke Cerebrovasc Dis. 2020 Feb;29(2):104544. doi: 10.1016/j.jstrokecerebrovasdis.2019.104544. Epub 2019 Dec 6.
PubMed 31818684Ward NS, Brander F, Kelly K. Intensive upper limb neurorehabilitation in chronic stroke: outcomes from the Queen Square programme. J Neurol Neurosurg Psychiatry. 2019 May;90(5):498-506. doi: 10.1136/jnnp-2018-319954. Epub 2019 Feb 15.
PubMed 30770457Israely S, Leisman G, Carmeli E. Improvement in Hand Trajectory of Reaching Movements by Error-Augmentation. Adv Exp Med Biol. 2018;1070:71-84. doi: 10.1007/5584_2018_151.
PubMed 29564773Huang VS, Haith A, Mazzoni P, Krakauer JW. Rethinking motor learning and savings in adaptation paradigms: model-free memory for successful actions combines with internal models. Neuron. 2011 May 26;70(4):787-801. doi: 10.1016/j.neuron.2011.04.012.
PubMed 21609832
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Error-enhancement as Basis for Novel Upper Limb Rehabilitation in the Chronic Phase After Stroke: a 5-day Pre-post Intervention Study.
- ClinicalTrials.gov ID
- NCT05229185
- Acronym / sponsor ID
- s65699
- Conditions
- Chronic Stroke
- Keywords
- upper limb, neurorehabilitation, error-enhancement, robotic treatment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven, BioXtreme
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 23 Nov 2022 (actual)
- Study completion
- 23 Nov 2022 (actual)
- First posted
- 8 Feb 2022 (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.
Even in a chronic phase after stroke, most patients have difficulty moving the affected arm, resulting in limitations in simple tasks in daily living, most frequently limiting reaching task. In the chronic phase, significant improvements are usually no longer observed. Nevertheless, even these patients can still improve their functional abilities due to exercise-dependent plasticity.
A new device was developed, the deXtreme robot, a rehabilitation device that offers error-enhancement approach during three-dimensional movements. The goal error-enhancement is to elicit better accuracy, stability, fluidity and range of motion during reaching. games are projected on a screen, requiring 3D active reaching movements. The duration of the study for a single participant will be 7 consecutive working days, including 1 day of pre-intervention assessment, 5 days of training and 1 day of post-intervention assessment. The overall aim of this project is to gain knowledge into the potential of error-enhancement robot training in patients with upper limb impairments in the chronic phase after stroke. Hypothesizing that the 5-day training will have a positive effect on both the robotic and clinical outcome measures.
Detailed description
The overall aim of this study is to gain knowledge into the potential of error-enhancement robot training in patients with upper limb impairments in the chronic phase after stroke. Error-enhancement is characterized as unexpected external perturbation forces acting upon the upper limb during a reaching movement, causing the upper limb to deflect from the reaching pathway, and this results in errors. If one allows for repetitive reaching performance with the same systematic perturbation forces, then a decrease in errors and improvement in movement performance is expected. The robot used for the training, the DeXtreme, is a CE marked rehabilitation device that offers this error-enhancement approach during three-dimensional movements.
The pilot study has a pre-post intervention design, recruiting 20 patients in the chronic phase after stroke. Error-enhancement treatment will be provided on day 2 to 6, i.e., for 5 consecutive days and will consist of facilitation of accuracy, range of movement, stability, and smoothness. Algorithms provide progression in terms of accuracy, range of movement, stability and smoothness, depending upon the performance of the patient.
The treatment will start with the installation of the patient and a warming up, followed by a first block of DeXtreme training. Then a short break is given followed by a short conventional therapy session. The content of the conventional therapy will involve active relaxation, focusing on stretching and (auto-)mobilisation. Afterwards, a second block of training with the DeXtreme follows, and it finishes with a cooling down. A therapist trained by the company will provide all assessment and training sessions. Training with the DeXtreme is additional to the conventional therapy the patient receives. Therefore, a diary of their conventional therapy sessions will be kept, and the content will be reviewed with the patient.
Advancements in upper limb motor function and activity will be evaluated through a triad of measurements including clinical and patient-reported outcomes, error-enhancement variables, and objective quantification of uni- and bimanual sensorimotor function by making use of the KINARM robotic manipulandum. These tests and questionnaires are administered on day 1 and day 7.
The aim of the study is to investigate whether patients with upper limb impairments in a chronic phase after stroke clinical and meaningful benefits from 5 hours DeXtreme training. In addition, it is examined whether improvements in the upper limb outcome is the result of restitution or compensation in the upper limb function.
In order to evaluate whether a randomized controlled trial is useful, the investigators will analyse the outcomes of our study twofold. (1) At group level, the investigators will calculate mean and standard deviation or median and interquartile range (based on whether data is normally distributed or not) and evaluate whether pre- to post-intervention scores for clinical, deXtreme and objective outcomes are significantly improved by means of Wilcoxon signed rank test (nonparametric), at a 0,05 significance level. Each p-value will be interpreted in a descriptive manner.
(2) At patient level, the investigators will evaluate how many patients (%) achieve a clinically significant improvement based on the therapy provided.
To see if the improvement might be explained by restitution or compensation, the association between the scores of the MAL-14 and the visually guided reaching task of the KINARM will be explored by Spearman correlations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study has a pre-post intervention design, recruiting 20 patients in the chronic phase after stroke. Pre- and post-intervention assessments are administered on day 1 and 7.The 5 days in between, all patients receive the same training with the robot, there is no control group.
| Arm | Type | Receives |
|---|---|---|
| DeXtreme (Error-enhacement) | Experimental | Device: DeXtreme training (error-enhancement)Training (error-enhancement): 5 consecutive days, 1 hour per day |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- First stroke, confirmed by neurologist based on clinical and/or imaging findings
- Ischemic/hemorrhagic stroke, at least more than six months ago
- Stroke affecting the dominant/non-dominant upper limb (unilateral weakness)
- Less than 85 years old
Key exclusion criteria (6 listed)
- Having sensory aphasia (evaluated by item 9 of the National Institutes of Health Stroke Scale)
- Having apraxia (evaluated by the apraxia screen of TULIA)
- Having neglect (evaluated by the Star Cancellation Test)
- Cognitive deficit with a score under 24 out of 30 on the Mini-mental State Examination
- Shoulder pain (yes/no)
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 |
|---|---|---|
| DeXtreme training (error-enhancement)15-20 min DeXtreme - 15 min conventional therapy - 15-20 min DeXtreme | Device | DeXtreme (Error-enhacement) |
Primary outcome
Action research arm test
Time frame: day 1(pre) - day 7 (post)
Evaluating UL functional ability, providing information whether improvement in impairment (FMA-UE) results in increased activity level. Internationally accepted outcome measure for stroke studies, and extensive experience available in the research group. min-max: 0-57 (higher = better)
Fugl-Meyer motor assessment upper extremity
Time frame: day 1(pre) - day 7 (post)
Evaluating UL motor impairment (shoulder, elbow, wrist, hand and fingers), ability to measure restoration of function due to improved quality of movement. Internationally accepted outcome measure for stroke studies, and extensive experience available in the research group. min-max: 0-66 (higher = better)
Kinarm: visually guided reaching task
Time frame: day 1(pre) - day 7 (post)
Assessment of motor function using a 4-target centre-out reaching task on the Kinarm End-Point Lab.
DeXtreme: reaching task - Market stand
Time frame: day 1(pre) - day 7 (post)
Assessment of motor function using reaching tasks on the DeXtreme robot (range of motion and accuracy).
DeXtreme: reaching task - Alchemist
Time frame: day 1(pre) - day 7 (post)
Assessment of motor function using reaching tasks on the DeXtreme robot (stability and smoothness).
7 secondary outcomes
Visual analogue scale (VAS) - Pain
Time frame: day 1(pre) - day 7 (post); after treatment (day 2-5)
Motor assessment scale - tonus
Time frame: day 1(pre) - day 7 (post); after treatment (day 2-5)
Kinarm: sensory processing task
Time frame: day 1(pre) - day 7 (post)
Motor assessment scale - upper limb
Time frame: day 1(pre) - day 7 (post)
Stroke impact scale - Hand
Time frame: day 1(pre) - day 7 (post)
Motor Activity Log - 14 items
Time frame: day 1(pre) - day 7 (post)
Kinarm: arm position matching task
Time frame: day 1(pre) - day 7 (post)
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 31 Mar 2023.
- Background: PubMed 31818684Kim RK, Kang N. Bimanual Coordination Functions between Paretic and Nonparetic Arms: A Systematic Review and Meta-analysis. J Stroke Cerebrovasc Dis. 2020 Feb;29(2):104544. doi: 10.1016/j.jstrokecerebrovasdis.2019.104544. Epub 2019 Dec 6.
- Background: PubMed 30770457Ward NS, Brander F, Kelly K. Intensive upper limb neurorehabilitation in chronic stroke: outcomes from the Queen Square programme. J Neurol Neurosurg Psychiatry. 2019 May;90(5):498-506. doi: 10.1136/jnnp-2018-319954. Epub 2019 Feb 15.
- Background: PubMed 29564773Israely S, Leisman G, Carmeli E. Improvement in Hand Trajectory of Reaching Movements by Error-Augmentation. Adv Exp Med Biol. 2018;1070:71-84. doi: 10.1007/5584_2018_151.
- Background: PubMed 21609832Huang VS, Haith A, Mazzoni P, Krakauer JW. Rethinking motor learning and savings in adaptation paradigms: model-free memory for successful actions combines with internal models. Neuron. 2011 May 26;70(4):787-801. doi: 10.1016/j.neuron.2011.04.012.
- 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?
A Early Phase 1 study testing DeXtreme training (error-enhancement) in people with Chronic Stroke, run by Universitaire Ziekenhuizen 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 6 inclusion and 6 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 31 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Action research arm test (time frame: day 1(pre) - day 7 (post)). 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?
On the ClinicalTrials.gov record for NCT05229185, which also lists 4 linked publications.
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 31 Mar 2023.