Clinical trial NCT05621980: Finger Movement Training After Stroke
Official title: A Multimodal Intervention to Improve Manual Dexterity in Subacute Stroke Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: stroke
FES
virtual reality
rehabilitation
Lead sponsor: North Carolina State University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-11-18
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change of Jebsen-Taylor Hand Function Test (JTHFT)
timeFrame: Change of value from before the intervention to immediately after the intervention.
Secondary outcomes:
measure: Change of Lateral pinch strength
timeFrame: Change of value from before the intervention to immediately after the intervention.
measure: Change of 3-point pinch strength
timeFrame: Change of value from before the intervention to immediately after the intervention.
measure: Change of Touch sensitivity
timeFrame: Change of value from before the intervention to immediately after the intervention.
measure: Change of Box and Blocks Test (BBT)
timeFrame: Change of value from before the intervention to immediately after the intervention.
measure: Change of 9-Hole Peg Test (9PHT)
timeFrame: Change of value from before the intervention to immediately after the intervention.
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Hand Rehabilitation Lab
state: North Carolina
Study officials:
References:
citation: Connelly L, Jia Y, Toro ML, Stoykov ME, Kenyon RV, Kamper DG. A pneumatic glove and immersive virtual reality environment for hand rehabilitative training after stroke. IEEE Trans Neural Syst Rehabil Eng. 2010 Oct;18(5):551-9. doi: 10.1109/TNSRE.2010.2047588. Epub 2010 Apr 8.
citation: Thielbar KO, Lord TJ, Fischer HC, Lazzaro EC, Barth KC, Stoykov ME, Triandafilou KM, Kamper DG. Training finger individuation with a mechatronic-virtual reality system leads to improved fine motor control post-stroke. J Neuroeng Rehabil. 2014 Dec 26;11:171. doi: 10.1186/1743-0003-11-171.
citation: Shin H, Hu X. Flexibility of Finger Activation Patterns Elicited through Non-invasive Multi-Electrode Nerve Stimulation. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:1428-1431. doi: 10.1109/EMBC.2018.8512479.