Error Augmentation for Upper Limb Rehabilitation in Stroke Survivors

NCT07039006 | Completed

• 1 other identifier: MP-50-2020-1209
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke

Keywords

stroke; motor learning; error augmentation; reaching

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, immediately post-training, 1 hour post intervention.

Secondary Outcomes (4)

• Change in endpoint accuracy

  Baseline, immediately post-training, 1 hour post intervention.

• Change in movement time

  Baseline, immediately post-training, 1 hour post intervention.

• Change in path smoothness

  Baseline, immediately post-training, 1 hour post intervention.

• Change in path straightness

  Baseline, immediately post-training, 1 hour post intervention.

Study Arms (2)

Training with EA feedback

EXPERIMENTAL

Subjects will undergo reaching training that includes EA feedback as a 30-degree elbow flexion error.

Behavioral: Training with EA feedback

Training without EA feedback

SHAM COMPARATOR

Subjects will undergo reaching training that does not include EA feedback.

Behavioral: Training without EA feedback

Interventions

Training with EA feedback BEHAVIORAL

Subjects will undergo reaching training that includes a 30-degree elbow flexion error 3 times in 1 week.

Training with EA feedback

Training without EA feedback BEHAVIORAL

Subjects will undergo reaching training that does not include EA feedback 3 times in 1 week.

Training without EA feedback

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

Jewish Rehabilitation Hospital

Montreal, Quebec, H7V 1R2, Canada

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mindy F Levin, PT, PhD

  School of Physical and Occupational Therapy, McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Mindy F. Levin

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 26, 2025
• Study Start: January 1, 2022
• Primary Completion: May 29, 2025
• Study Completion: May 29, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)