Cerebrovascular Stroke
Conditions
Keywords
Stroke, Physical therapy, neurorehabilitation, motor function, neuroplasticity, neuroimaging, MRI, TDI, Hemiparesis, occupational therapy, patient focused, motor learning, motor control, skill acquisition, skill training, motor recovery, task-oriented training, task-specific training, arm function, upper extremity, arm therapy, physical rehabilitation, arm rehabilitation
Brief summary
Every year, almost 800,000 people experience a stroke in the United States, which lead to upper-limb impairments, making recovery of motor function a priority in stroke rehabilitation. 1) The primary objective of this study is to determine whether fast arm movement training on a tracking task ("Speed-training"), in chronic stroke survivors with mild to moderate paresis, will generalize to improve arm function better than dose-equivalent accuracy training on the same task. 2) study the effect of intensive arm training on the recovery of anticipatory feedforward control. 3) Determine the involvement of cerebellar-cortical circuits in the recovery of arm movements due to speed training.
Detailed description
About 65% of stroke survivors experience long-term limitations in upper extremity (UE) functions. In particular, limitations in arm reaching movements are prominent and correlate strongly with patients' impairment levels. Because activities of daily living often involve the UEs, retraining reach and grasp skills is critical for return to a full quality-of-life. Yet, the training parameters required for effective rehabilitation of UE function are not known. Recent evidence suggests that high-speed movements during training are effective at improving arm movements in individuals with chronic stroke. Hence, fast movements generating large errors, would promote the restoration of the feedforward controllers and therefore improves arm movements and UE functions in individuals with chronic stroke. Because the cerebellum is involved in learning feedforward controllers from motor errors, the improvements would be proportional to the integrity of the cerebellar-cortical networks. A double-blind quasi-randomized controlled study will be carried out in chronic post-stroke survivors. Participants will be assigned to either the speed-bias training group or a dose equivalent accuracy-bias training group (control) and will receive 4 days of training over a 1week period by a trained Occupational or physical therapist. Behavioral, EMG, and MRI data will be acquired within two weeks before, 3 days post, and one month after intervention.
Interventions
BEHAVIORALFast intervention
This intervention is based on recent body of evidence that high-speed movements during training are effective at improving arm movements in individuals with chronic stroke.Participants will be rewarded for movements performed within a short amount of time.
BEHAVIORALActive Monitoring
This is an observation-only group. The training received in this group will be dose equivalent to the active group.
Sponsors
University of Southern California
Casa Colina Hospital and Centers for Healthcare
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessments will be done by a blinded and standardized clinical researcher
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 6 months following an ischemic supratentorial stroke * At least 21 years of age * Exhibit residual capability to move the paretic UE (Upper Extremity Fugl- Meyer motor score \>20/66) * Able to follow a 2-step command (8th item on the MMSE test) * Able to perform an unassisted arm reach movement of 25 cm ahead of the body within 5 seconds with trunk restraint * Exhibit no greater than mild/moderate spasticity as assessed with a Modified Ashworth Score \< 3
Exclusion criteria
* any neurologic diagnoses other than stroke * peripheral movement restrictions, such as neuropathy * orthopedic disorders affecting the paretic UE * severe pain or sensory/proprioceptive impairment in the more affected UE * visual neglect (more than 4% of lines left uncrossed on Albert's test). * had a stroke directly affecting the cerebellum * any contra-indications to MRI scanning * mostly resolved impairments with an Upper Extremity Fugl- Meyer motor score \>58/66
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Arm Reaching Movement Time. | Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days | Average movement time for 30 planar reaching movements to targets arrayed on a planar workspace. Negative changes indicate that participants moved faster to the targets following the intervention. |
| Change in Movement Smoothness | Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days | Average movement smoothness for 30 planar reaching movements to target arrayed on a planar workspace. Smoothness is computed by number of peaks in hand tangential velocity profiles of arm-reaching movements. Negative changes indicate that participants had smoother movement to the targets following the intervention. |
| Change in Speed Accuracy Trade-off | Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days | The speed-accuracy trade-off of reaching movements was assessed as a linear relationship between movement time and the Index of Difficulty : log ratio of the movement distance to target size. Negative changes indicate that participants are less affected by the index of difficulty, reflecting a better speed-accuracy trade-off. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Action Research Arm Test (ARAT) | Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days | The ARAT assesses specific changes in upper limb function among individuals who have sustained a stroke.The test consists of performing functional reaching tasks, with each sub-task scored on a scale from 0 to 3, where a score of 3 indicates the movement was performed normally. Scores range from 0 to 57, with higher scores indicating better performance. Positive changes reflect improvements in limb function. |
| Change in Upper Extremity Fugl-Meyer (UEFM) | Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days | The UEFM is a test used to assess sensorimotor impairments in the upper extremity most affected by stroke. The test consists of performing specific upper extremity movements, with each sub-task scored on a scale from 0 to 2, where a score of 2 indicates normal performance. Scores range from 0 to 66, with higher scores indicating better performance. Positive changes reflect improvements in motor function. |
| Change in Box and Block Test Score (BBT) | Change from baseline (assessed during the week preceding the intervention) to 3 days post-intervention, representing an average interval of 12 days | The Box and Block Test (BBT) measures unilateral gross manual dexterity. The test involves moving, one by one, as many blocks as possible from one compartment of a box to an adjacent, identical compartment within 60 seconds. Scores range from 0 to 150, with higher scores indicating better performance. Positive changes reflect improvements in upper limb function. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNicolas Schweighofer, PhD
University of Southern California
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 12 Participants |
| Upper Extremity Fugl-Meyer (UEFM) | 42.9 Scores on a scale STANDARD_DEVIATION 1.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 1 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
None listed