Finger Movement Training After Stroke

ConditionStroke

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21+

SponsorNorth Carolina State University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

Actuated Virtual Keyboard (AVK) system
Behavioral
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.
Occupational Therapy (OT)
Behavioral
Traditional occupational therapy training sessions.

Treatment groups

36 Participants

are divided into 2 treatment groups

Group A: Functional electrical stimulation (FES) + AVK groupExperimental treatment 1 intervention

Group B: OT GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change of Jebsen-Taylor Hand Function Test (JTHFT)

A standardized and objective measure of fine and gross motor hand function using simulated activities of daily living.

Time frame