Coordination Lack, Stroke, Weakness, Muscle
Conditions
Keywords
hand, stroke, therapy, rehabilitation
Brief summary
Evaluation of a new EMG controlled game to improve hand function in chronic stroke survivors.
Detailed description
Increased impairment of the hand is commonly reported as an outcome occurring after a stroke. This impairment is due mainly to the decreased ability to modulate appropriate muscle activation patterns. Issues with appropriately modifying activation patterns can profoundly affect tasks of daily living. This study is evaluating a novel software focusing on retraining hand muscle activation patterns through an Electromyographic (EMG) controlled game. Stroke survivors with chronic, severe hemiparesis of the hand will participate in a longitudinal study consisting of 3 weeks of training. We hypothesize that stroke survivors will experience a decrease in time to complete a test of EMG control, as well as improvement in hand motor control.
Interventions
OTHERBilateral
Participants will control game using EMG from both upper limbs.
OTHERUnilateral
Participants will control game using EMG from the more impaired upper limb.
Sponsors
Shirley Ryan AbilityLab
North Carolina State University
Marquette University
Medical University of South Carolina
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Single, unilateral stroke at least 6 months prior to enrollment * Moderate hand impairment defined by Stage 4 or Stage 5 on the Chedoke McMaster Stroke Assessment Scale
Exclusion criteria
* Visual neglect or deficits (with inability to compensate) * Upper extremity orthopedic conditions that interfere with movement * Cerebellar stroke Children, prisoners, or adult unable to provide consent will not be recruited. As the procedures pose no increased risk for pregnant women, we will not specifically exclude them.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Completion Time for Timed Test | Baseline and 3 weeks (immediately post intervention) | Time to complete movement to 16 randomized targets |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElliot Roth, MD
Shirley Ryan AbilityLab
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 59.4 years STANDARD_DEVIATION 26.9 |
| Chedoke Stage of Hand Score Chedoke Hand Score of 4 | 8 Participants |
| Chedoke Stage of Hand Score Chedoke Hand Score of 5 | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
| Side of Impairment Left Affected | 9 Participants |
| Side of Impairment Right Affected | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
None listed