Stroke
Conditions
Keywords
stroke, FES, virtual reality, rehabilitation
Brief summary
Human development as a species has been strongly associated with the ability to dexterously manipulate objects and tools. Unfortunately, current therapy efforts typically fail to restore fine manual control after stroke. The goal of this study is to evaluate a new intervention that would combine targeted electrical stimulation of selected nerves with use a soft, pneumatically actuated hand exoskeleton to enhance repetitive practice of independent movements of the fingers and thumb in order to improve rehabilitation of hand function after stroke. The investigators will recruit stroke survivors in the subacute phase of recovery (2-18 months post-stroke). These participants will be involved in a 5-week intervention involving 15 training sessions. During these sessions, participants will train independent movement of the digits of the paretic hand. Evaluation of motor control of the paretic hand will occur prior to initiation of training, at the midpoint of the training period, after completion of training, and one month later.
Interventions
BEHAVIORALActuated Virtual Keyboard (AVK) system
The participant controls an avatar hand by the movement of their own digits. Each avatar digit corresponds to a given virtual key. "Sufficient" digit flexion results in "playing" of that key, with visual and auditory feedback of key strike. Participants will wear a soft exoskeleton, the PneuGlove, with embedded bend sensors to provide real-time measurement of digit flexion. Pneumatic resistance to flexion can be applied to each digit independently, along with extension assistance, through air chambers running through the glove. The FES is intended to assist finger flexion by activating extrinsic finger flexor muscles. A high-density 2×8 stimulation electrode grid will be placed over the median and ulnar nerves at the medial side of the upper arm. The stimulator can deliver electrical stimulation to any pair of electrodes. At the beginning of each session, the investigators will identify the electrode pairs which best produce flexion of each digit with minimal discomfort.
BEHAVIORALOccupational Therapy (OT)
Traditional occupational therapy training sessions.
Sponsors
North Carolina State University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A single, unilateral stroke 2-18 months prior to enrollment * Moderate to mild hand impairment, as determined by a rating of Stage 4-6 on the Stage of Hand section of the Chedoke-McMaster Stroke Assessment * Visual capacity to discern specific shapes on the computer screen * Capacity to provide informed consent
Exclusion criteria
* Rigid contractures in the joints of the upper limbs, or orthopedic issues precluding joint movement * Hemispatial neglect (as assessed by the Behavioral Inattention Test) * Excessive pain in the paretic upper limb (visual analog scale of shoulder pain \< 70)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Jebsen-Taylor Hand Function Test (JTHFT) | Change of value from before the intervention to immediately after the intervention. | A standardized and objective measure of fine and gross motor hand function using simulated activities of daily living. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Lateral pinch strength | Change of value from before the intervention to immediately after the intervention. | Force produced when the thumb pinches against the radial side of the index finger as if holding a key. |
| Change of 3-point pinch strength | Change of value from before the intervention to immediately after the intervention. | Force produced when thumb pinches against the tips of the index and middle fingers. |
| Change of Touch sensitivity | Change of value from before the intervention to immediately after the intervention. | Touch sensitivity will be measured with von Frey hairs (Aesthesio®). |
| Change of Box and Blocks Test (BBT) | Change of value from before the intervention to immediately after the intervention. | A quick, simple and inexpensive test to measures unilateral gross manual dexterity. |
| Change of 9-Hole Peg Test (9PHT) | Change of value from before the intervention to immediately after the intervention. | A standardized, quantitative assessment used to measure finger dexterity. |
Countries
United States
Outcome results
None listed