Error Augmentation Motor Learning Training Approach in Stroke Patients

NCT04378946 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2020-05-07

No results posted yet for this study

Summary

Deficits in upper limb (UL) functional recovery persist in a large proportion of stroke survivors. Understanding how to obtain the best possible UL recovery is a major scientific, clinical and patient priority. We propose that UL motor recovery may be improved by training that focuses on remediating an individual's specific motor impairment. Our approach is based on evidence that deficits in the control of muscle activation thresholds (spatial thresholds) of the elbow in stroke underlie impairments such as disordered movement and spasticity. Our novel training program focuses on improving the individual's active elbow control range using error augmentation (EA) feedback. Since training intensity and lesion load are key factors in motor recovery that lack guidelines, we will also investigate effects of exercise dose and corticospinal tract (CST) injury on UL recovery.

In this multicenter, double-blind, parallel-group, randomized controlled trial (RCT), patients with stroke will participate in an individualized intensive technology-assisted reaching training program, based on error augmentation (EA), in order to improve voluntary elbow function. They will practice robot-assisted reaching in a virtual reality (VR) game setting. We will identify if intensive training with feedback aimed at expanding the range of spatial threshold (ST) control at the elbow (experimental group) is better than intensive training with general feedback about task success (control group). We will also determine the patient-specific optimal therapy dose by comparing kinematic and clinical outcomes after 3, 6 and 9 weeks of intensive training, and again at 4 weeks after training to determine carry-over effects. We will quantify the severity of the participant's motor deficit, as the amount of cortico spinal tract (CST) injury due to the stroke (%CST injury) and relate training gains to their %CST injury. Results of this pragmatic trial will provide essential information for optimizing individualized post-stroke training programs and help determine optimal patient-specific training dosing to improve motor recovery in people with different levels of stroke severity.

This type of research involving personalized, impairment-based feedback and dose-effective training has the potential to significantly improve rehabilitation for a greater number of post-stroke individuals and improve the health and quality of life of Canadians.

Conditions

  • Stroke Rehabilitation
  • Cerebrovascular Stroke
  • Muscle Spasticity
  • Upper Extremity Paresis

Interventions

BEHAVIORAL

Intensive physical rehabilitation type training

Multiple reaching tasks aiming at increasing voluntary elbow range of motion

DEVICE

Robotic system for supporting and monitoring arm motion

Ergonomic double-joint horizontal manipulandum mounted on a rigid, movable arm (used to support UL movement during tasks). An electromyogram (EMG) is used to monitor elbow extensor and flexor muscle activity. A motion tracking device based on the Kinect II skeleton ( with Kalman filter to improve accuracy). Simple Virtual Reality Reaching Game providing visual feedback with screen display of the subject's arm avatar and arm workspace for the VR training.

DEVICE

Actigraph Activity Monitor

Used during and outside training sessions, this device is worned on the affected wrist that records activity (movements metrics) as a measure of upper extremity as well as heart rate

DIAGNOSTIC_TEST

Magnetic resonance imaging (MRI)

Done once before treatment (PRE)

DIAGNOSTIC_TEST

Montreal Spasticity Measure (MSM)

Used to identify the actual spatial threshold (ST) prior to every training session

Sponsors & Collaborators

Principal Investigators

  • Mindy F Levin, PhD · McGill University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-12-31
Completion
2023-08-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04378946 on ClinicalTrials.gov