Muscle Spasticity Clinical Trial
Official title:
Making Training Better: Error Augmentation Motor Learning in Stroke
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.
Status | Not yet recruiting |
Enrollment | 54 |
Est. completion date | August 31, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility |
Inclusion Criteria: - First cortical/sub-cortical ischemic/hemorrhagic stroke less than 1 year previously - Sub-acute stage - Medically stable - Not in treatment - Arm paresis (Chedoke-McMaster Arm Scale of 2-6 out of 7 - Some voluntary elbow movement (30° per direction) - Able to provide informed consent Exclusion Criteria: - Major neurological neuromuscular/orthopaedic/pain problems - Marked proprioceptive deficits at the elbow (<6/12 Fugl-Meyer UL Proprioception Scale) - Visuospatial neglect - Uncorrected visual deficits - Major cognitive deficits (< 26 on MOCA) - Depression (> 14 on BDI II) |
Country | Name | City | State |
---|---|---|---|
Canada | CRIR | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in elbow spatial threshold (ST) angle and the range of active elbow extension | The elbow ST angle will be identified with the Montreal Spasticity Measure (MSM). The range of active elbow extension during a standardized reach-to-grasp Test Task made to a hollow cone placed in the subject's midline will be evaluated. This task has been used in previous clinical trials to test reaching in a similar stroke cohort and norms for healthy participants are available. Although only the reach-to-grasp movement will be analyzed, the whole task will be done so that the action is more functional (e.g., having a specific purpose). |
Before treatment baseline, week 3, week 6, week 9 and week 13 | |
Secondary | Arm workspace area, movement quality variables, clinical measures of UL functional level | Secondary outcomes are i) the area of the active arm workspace; ii) movement quality variables (i.e., endpoint trajectory smoothness, straightness, speed and precision; shoulder joint range and interjoint coordination) during a Test Task; iii) clinical measures of UL impairment, activity and participation. | Before treatment baseline, week 3, week 6, week 9 and week 13 | |
Secondary | Change in arm workspace area during reach task | Maximum active reaching area on horizontal plane measured by robotic support system | Before treatment baseline, week 3, week 6, week 9 and week 13 | |
Secondary | Change in spasticity level at rest | As determined by the Montreal spasticity measure | Before treatment baseline, week 3, week 6, week 9 and week 13 | |
Secondary | Change in straightness of elbow trajectory during reach task | Using motion analysis system of the robotic support system | Before treatment baseline, week 3, week 6, week 9 and week 13 | |
Secondary | Change in speed of endpoint movement during reach task | Using motion analysis system of the robotic support system | Before treatment baseline, week 3, week 6, week 9 and week 13 | |
Secondary | Change in smoothness of endpoint trajectory during reach task | Using motion analysis system of the robotic support system | Before treatment baseline, week 3, week 6, week 9 and week 13 | |
Secondary | Change in accuracy relative to target during reach task | Using motion analysis system of the robotic support system | Before treatment baseline, week 3, week 6, week 9 and week 13 | |
Secondary | Change in Fugl-Meyer Assessment Upper extremity (FMA) | Upper extremity volitional movement, reflex activity, active wrist and hand movement, coordination/speed, sensation, passive joint motion, pain. Max score of 66 | Before treatment baseline, week 3, week 6, week 9 and week 13 | |
Secondary | Change in streamlined Wolf Motor Function Test (WMFT) | Measure of dexterity, strength and upper extremity function | Before treatment baseline, week 3, week 6, week 9 and week 13 |
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