StrokeNCT07039006
Error Augmentation for Upper Limb Rehabilitation in Stroke Survivors
A study testing Training with EA feedback and Training without EA feedback in people with Stroke, run by McGill University at 1 site in Canada.
Trial summary
Stroke can severely limit a person's ability to move their arm, especially when trying to reach by extending the elbow. These challenges often persist long after the stroke and make everyday activities more difficult. 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 EA feedback and Training without EA feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2022to 29 May 2025
- 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
- Sustained a first-ever cortical/sub-cortical ischemic/hemorrhagic stroke ≥6 mo and ≤5 yr previously
- Has no medical complications
- Has arm paresis but can voluntarily flex/extend the elbow ~30 degrees
- Can provide informed consent
Who cannot join
- Has other major neurological or musculoskeletal problems that would interfere with task performance
- Has marked elbow proprioceptive deficits (<6/12 Fugl-Meyer Assessment for the Upper-Limb (FMA-UL) Sensation Scale)
- Has visuospatial neglect (Line Bisection Test)
- Has uncorrected vision
- Has depression (>14 on Beck Depression Inventory II)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Error Augmentation for Upper Limb Rehabilitation in Stroke Survivors: a Proof-of-concept Study
Stroke can severely limit a person's ability to move their arm, especially when trying to reach by extending the elbow. These challenges often persist long after the stroke and make everyday activities more difficult. The investigators are testing a feedback strategy called error augmentation (EA) feedback that intentionally exaggerates movement errors to promote motor learning.
In this study, the investigators designed a virtual reality training program that uses EA feedback to encourage people with chronic stroke to use more elbow extension during reaching. The EA feedback makes it appear as though the elbow is more bent than it actually is, prompting the participant to extend their elbow further than they normally would. By having the patient practice movement with enhanced feedback, the investigators predict that the patient will increase the range of motion and improve reaching ability.
Read more
This is a short, proof-of-concept study to evaluate whether EA feedback shows early promise for improving arm movement in people with upper limb motor impairment after stroke. Participants are randomly assigned to either an EA training group or a control group (no-EA feedback). Each person completes three 30-minute virtual reality training sessions over 1 week. The investigators assess arm movement and motor impairment before and after training, and again one hour after the training to determine if improvements are retained.
Findings from this preliminary study will help determine whether this EA-based training approach should be used in a longer 9-week clinical trial aimed at promoting long-term recovery of arm function after stroke.
- Conditions
- Stroke
- Being tested
- Training with EA feedback, Training without EA feedback
- Keywords
- stroke, motor learning, error augmentation, reaching
- 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 EA feedbackBehavioural
Subjects will undergo reaching training that includes a 30-degree elbow flexion error 3 times in 1 week.
Training without EA feedbackBehavioural
Subjects will undergo reaching training that does not include EA feedback 3 times in 1 week.
| Study group | Role | What they receive |
|---|---|---|
| Training with EA feedback | Experimental | Subjects will undergo reaching training that includes EA feedback as a 30-degree elbow flexion error. Receives: Behavioral: Training with EA feedback |
| Training without EA feedback | Sham comparator | Subjects will undergo reaching training that does not include EA feedback. Receives: Behavioral: Training without EA feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in whole arm active workspace area
The size of the active arm workspace area will be expressed as a ratio of the active workspace determined when the subject actively moves their arm through the horizontal workspace to the passive workspace that is defined by the examiner moving the arm through the same space.
Measured: Prior to training.
Change in the trunk-based index of performance
Described as a measure of reaching precision accounting for accuracy and speed of reaching together with the amount of trunk compensation.
Measured: Baseline, immediately post-training, 1 hour post intervention.
Change in elbow extension angle at reaching offset
Elbow extension during a functional Test Task is calculated based on vectors between the markers placed on the acromion and the lateral epicondyle and between the lateral epicondyle and ulnar head of the affected arm. Arm movement onset/offset will be determined as the times at which the velocity of the endpoint marker increases/decreases and remains above/below 10% of the peak velocity.
Measured: Baseline, immediately post-training, 1 hour post intervention.
Secondary outcomes (4)
Change in endpoint accuracy
The x,y root mean square distance between the endpoint marker and the target at the end of a reaching movement.
Measured: Baseline, immediately post-training, 1 hour post intervention.
Change in movement time
The time between the onset and offset of the movement.
Measured: Baseline, immediately post-training, 1 hour post intervention.
Change in path smoothness
The number of peaks on a tangential velocity trace of each reaching trial.
Measured: Baseline, immediately post-training, 1 hour post intervention.
Change in path straightness
Described using the index of curvature where the ratio between the actual movement path and a straight line path between the initial and final targets.
Measured: Baseline, immediately post-training, 1 hour post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Jan 2022
- Primary completion29 May 2025
- Study completion29 May 2025
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mindy F. Levin, McGill University
- Investigators
- Mindy F Levin, PT, PhD, Principal investigator, School of Physical and Occupational Therapy, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039006
- Sponsor's protocol ID
- MP-50-2020-1209
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be used for the purposes of this study only.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Error Augmentation for Upper Limb Rehabilitation in Stroke Survivors: a Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT07039006
- Acronym / sponsor ID
- MP-50-2020-1209
- Conditions
- Stroke
- Keywords
- stroke, motor learning, error augmentation, reaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 26 Jun 2025 (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.
Stroke can severely limit a person's ability to move their arm, especially when trying to reach by extending the elbow. These challenges often persist long after the stroke and make everyday activities more difficult. The investigators are testing a feedback strategy called error augmentation (EA) feedback that intentionally exaggerates movement errors to promote motor learning.
In this study, the investigators designed a virtual reality training program that uses EA feedback to encourage people with chronic stroke to use more elbow extension during reaching. The EA feedback makes it appear as though the elbow is more bent than it actually is, prompting the participant to extend their elbow further than they normally would. By having the patient practice movement with enhanced feedback, the investigators predict that the patient will increase the range of motion and improve reaching ability.
This is a short, proof-of-concept study to evaluate whether EA feedback shows early promise for improving arm movement in people with upper limb motor impairment after stroke. Participants are randomly assigned to either an EA training group or a control group (no-EA feedback). Each person completes three 30-minute virtual reality training sessions over 1 week. The investigators assess arm movement and motor impairment before and after training, and again one hour after the training to determine if improvements are retained.
Findings from this preliminary study will help determine whether this EA-based training approach should be used in a longer 9-week clinical trial aimed at promoting long-term recovery of arm function after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training with EA feedback | Experimental | Behavioral: Training with EA feedbackSubjects will undergo reaching training that includes EA feedback as a 30-degree elbow flexion error. |
| Training without EA feedback | Sham comparator | Behavioral: Training without EA feedbackSubjects will undergo reaching training that does not include EA feedback. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sustained a first-ever cortical/sub-cortical ischemic/hemorrhagic stroke ≥6 mo and ≤5 yr previously
- Has no medical complications
- Has arm paresis but can voluntarily flex/extend the elbow ~30 degrees
- Can provide informed consent
Key exclusion criteria (5 listed)
- Has other major neurological or musculoskeletal problems that would interfere with task performance
- Has marked elbow proprioceptive deficits (<6/12 Fugl-Meyer Assessment for the Upper-Limb (FMA-UL) Sensation Scale)
- Has visuospatial neglect (Line Bisection Test)
- Has uncorrected vision
- Has depression (>14 on Beck Depression Inventory II)
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 EA feedbackSubjects will undergo reaching training that includes a 30-degree elbow flexion error 3 times in 1 week. | Behavioural | Training with EA feedback |
| Training without EA feedbackSubjects will undergo reaching training that does not include EA feedback 3 times in 1 week. | Behavioural | Training without EA feedback |
Primary outcome
Change in whole arm active workspace area
Time frame: Prior to training.
The size of the active arm workspace area will be expressed as a ratio of the active workspace determined when the subject actively moves their arm through the horizontal workspace to the passive workspace that is defined by the examiner moving the arm through the same space.
Change in the trunk-based index of performance
Time frame: Baseline, immediately post-training, 1 hour post intervention.
Described as a measure of reaching precision accounting for accuracy and speed of reaching together with the amount of trunk compensation.
Change in elbow extension angle at reaching offset
Time frame: Baseline, immediately post-training, 1 hour post intervention.
Elbow extension during a functional Test Task is calculated based on vectors between the markers placed on the acromion and the lateral epicondyle and between the lateral epicondyle and ulnar head of the affected arm. Arm movement onset/offset will be determined as the times at which the velocity of the endpoint marker increases/decreases and remains above/below 10% of the peak velocity.
4 secondary outcomes
Change in endpoint accuracy
Time frame: Baseline, immediately post-training, 1 hour post intervention.
Change in movement time
Time frame: Baseline, immediately post-training, 1 hour post intervention.
Change in path smoothness
Time frame: Baseline, immediately post-training, 1 hour post intervention.
Change in path straightness
Time frame: Baseline, immediately post-training, 1 hour post intervention.
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 26 Jun 2025.
- Individual participant dataSharing planned: No. Data will be used for the purposes of this study only.
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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.
Mindy F Levin, PT, PhD principal investigator
School of Physical and Occupational Therapy, McGill University
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 EA feedback and Training without EA feedback in people with Stroke, run by McGill University at 1 site in Canada.
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 4 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: finished, as of the sponsor's last update on 26 Jun 2025. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
Change in whole arm active workspace area (time frame: Prior to training.). The study lists 3 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 26 Jun 2025.