- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07039006
- Original Trial
Error Augmentation for Upper Limb Rehabilitation in Stroke Survivors
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H7V 1R2
- Jewish Rehabilitation Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Training with EA feedback
Subjects will undergo reaching training that includes EA feedback as a 30-degree elbow flexion error.
|
Subjects will undergo reaching training that includes a 30-degree elbow flexion error 3 times in 1 week.
|
|
Sham Comparator: Training without EA feedback
Subjects will undergo reaching training that does not include EA feedback.
|
Subjects will undergo reaching training that does not include EA feedback 3 times in 1 week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Prior to training.
|
|
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.
|
Baseline, immediately post-training, 1 hour post intervention.
|
|
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.
|
Baseline, immediately post-training, 1 hour post intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in endpoint accuracy
Time Frame: Baseline, immediately post-training, 1 hour post intervention.
|
The x,y root mean square distance between the endpoint marker and the target at the end of a reaching movement.
|
Baseline, immediately post-training, 1 hour post intervention.
|
|
Change in movement time
Time Frame: Baseline, immediately post-training, 1 hour post intervention.
|
The time between the onset and offset of the movement.
|
Baseline, immediately post-training, 1 hour post intervention.
|
|
Change in path smoothness
Time Frame: Baseline, immediately post-training, 1 hour post intervention.
|
The number of peaks on a tangential velocity trace of each reaching trial.
|
Baseline, immediately post-training, 1 hour post intervention.
|
|
Change in path straightness
Time Frame: Baseline, immediately post-training, 1 hour post intervention.
|
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.
|
Baseline, immediately post-training, 1 hour post intervention.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mindy F Levin, PT, PhD, School of Physical and Occupational Therapy, McGill University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MP-50-2020-1209
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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