Clinical trial NCT05268861: The Role of Cognition in Motor Learning After Stroke
Official title: The Role of Cognition in the Use of Enhanced Intrinsic Feedback for Motor Learning After Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke Hemorrhagic
Stroke, Ischemic
Cognitive Impairment
Keywords: virtual reality
motor learning
cognition
intrinsic feedback
cognitive impairment
imaging
error augmentation
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Montreal Neurological Institute and Hospital
name: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
First posted: 2022-03-07
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke leads to lasting problems in using the upper limb (UL) for everyday life activities. While rehabilitation programs depend on motor learning, UL recovery is less than ideal. Implicit learning is thought to lead to better outcomes than explicit learning. Cognitive factors (e.g., memory, attention, perception), essential to implicit motor learning, are often impaired in people with stroke. The objective of this study is to investigate the role of cognitive deficits on implicit motor learning in people with stroke. The investigators hypothesize that 1) subjects with stroke will achieve better motor learning when training with additional intrinsic feedback compared to those who train without additional intrinsic feedback, and 2) individuals with stroke who have cognitive deficits will have impairments in their ability to use feedback to learn a motor skill compared to individuals with stroke who do not have cognitive deficits.

A recent feedback modality, called error augmentation (EA), can be used to enhance motor learning by providing subjects with magnified motor errors that the nervous system can use to adapt performance. The investigators will use a custom-made training program that includes EA feedback in a virtual reality (VR) environment in which the range of the UL movement is related to the patient's specific deficit in the production of active elbow extension. An avatar depiction of the arm will include a 15 deg elbow flexion error to encourage subjects to increase elbow extension beyond the current limitations. Thus, the subject will receive feedback that the elbow has extended less than it actually has and will compensate by extending the elbow further. Subjects will train for 30 minutes with the EA program 3 times a week for 9 weeks. Kinematic and clinical measures will be recorded before, after 3 weeks, after 6 weeks, and after 9 weeks. Four weeks after the end of training, there will be a follow-up evaluation. Imaging scans will be done to determine lesion size and extent, and descending tract integrity with diffusion tensor imaging (DTI).

This study will identify if subjects with cognitive deficits benefit from individualized training programs using enhanced intrinsic feedback. The development of treatments based on mechanisms of motor learning can move rehabilitation therapy in a promising direction by allowing therapists to design more effective interventions for people with problems using their upper limb following a stroke.


Eligibility criteria: Inclusion Criteria:

* Sustained a first cortical/sub-cortical ischemic/hemorrhagic stroke less than 3 years previously and are medically stable.
* Are no longer receiving treatment.
* Normal or corrected-to-normal vision.
* Have arm paresis (Chedoke-McMaster Arm Scale 2-6/7) and spasticity (Modified Ashworth Scale ≥ 1/4) but can voluntarily flex/extend the elbow to approximately 30 degrees in each direction.

Exclusion Criteria:

* Other major neurological or musculoskeletal problems that may interfere with task performance.
* Marked elbow proprioceptive deficits (\<6/12 Fugl-Meyer UL sensation scale) that may interfere with elbow position perception.
* Visuospatial neglect (Line Bisection Test deviation \> 6 mm).
* Uncorrected vision.
* Depression (≥ 14 Beck Depression Inventory II).

Primary outcomes:
measure: Change in endpoint error
timeFrame: Change in endpoint error is assessed before the start of training and after 3 weeks, after 6 weeks, and after 9 weeks. The change in endpoint error is assessed again 4 weeks after the completion of training.
measure: Change in movement time
timeFrame: Change in movement time is assessed before the start of training and after 3 weeks, after 6 weeks, and after 9 weeks. The change in movement time is assessed again 4 weeks after the completion of training
measure: Change in path straightness
timeFrame: Change in path straightness is assessed before the start of training and after 3 weeks, after 6 weeks, and after 9 weeks. The change in path straightness is assessed again 4 weeks after the completion of training.
measure: Change in path smoothness
timeFrame: Change in path straightness is assessed before the start of training and after 3 weeks, after 6 weeks, and after 9 weeks. The change in path smoothness is assessed again 4 weeks after the completion of training.
measure: Change in range of active elbow extension
timeFrame: The change in the range of active elbow extension is assessed before the start of training and after 3 weeks, after 6 weeks, and after 9 weeks. The change in the range of active elbow extension is assessed again 4 weeks after the completion of training.
measure: Change in size of active arm workspace area
timeFrame: The change in the size of the active arm workspace area is assessed before the start of training and after 3 weeks, after 6 weeks, and after 9 weeks. The change in the size of the active arm workspace is assessed again 4 weeks after training.
Secondary outcomes:
measure: Correlation of the index of performance with the degree of cognitive and motor impairment, severity of damage to cortical areas, and white matter integrity.
timeFrame: Brain scans will be done prior to the start of training. Cognitive assessments and evaluations of motor impairment and activity are done prior to the start of training, after 3, after 6, after 9, and 4 weeks after the completion of training.
Other outcomes:
Locations:
city: Laval
country: Canada
facility: Jewish Rehabilitation Hospital
state: Quebec
Study officials:
affiliation: McGill University
name: Mindy Levin, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: