Error Augmentation for Upper Limb Rehabilitation in Stroke Survivors

NCT ID: NCT07039006

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2025-05-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Training with EA feedback

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

Group Type: EXPERIMENTAL

Training with EA feedback

Intervention Type: BEHAVIORAL

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

Training without EA feedback

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

Group Type: SHAM_COMPARATOR

Training without EA feedback

Intervention Type: BEHAVIORAL

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

Interventions

Training with EA feedback

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

Intervention Type: BEHAVIORAL

Training without EA feedback

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University

OTHER

Sponsor Role: lead

Responsible Party

Mindy F. Levin

Professor Mindy F. Levin

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mindy F Levin, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Physical and Occupational Therapy, McGill University

Locations

Jewish Rehabilitation Hospital

Montreal, Quebec, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

MP-50-2020-1209

Identifier Type: -

Identifier Source: org_study_id