Finger Movement Training After Stroke

North Carolina State University

Status: Enrolling

Conditions: Stroke

Treatments: Behavioral: Actuated Virtual Keyboard (AVK) system; Behavioral: Occupational Therapy (OT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05621980

22-2459 (Other Identifier)

23989

1R21HD105874-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups

Functional electrical stimulation (FES) + AVK group

Experimental group

Description:

This group will use the AVK system in combination with targeted FES to provide training of independent movement of each digit of the paretic hand. This training has two modes: Key Combination and Song. In the Key Combination mode, the subject will attempt to play the discrete key or key combinations specified on the computer screen to practice difficult movements and combinations. In the Song mode, sequential, rhythmic movements will be practiced as the participant is guided to play a series of keys, specified as falling keys, constituting five-note songs. Key Combination will be employed at the beginning and end of each training session to practice discrete movements that proved troubling during the current or previous session. Most of the session will be spent in the Song mode to emphasize the transitions from one movement to the next. In both modes the AVK system will trigger FES for the finger matching the desired key and signal the PneuGlove to resist movement of other digits.

Treatment:

Behavioral: Actuated Virtual Keyboard (AVK) system

OT Group

Active Comparator group

Description:

An occupational therapist will provide therapy of matching duration to the OT subject group. This will consist of 10 minutes of stretching of the finger muscles, particularly of the extrinsic finger flexors. This stretching will be followed by two 20-minute sessions of therapy focused on active task practice, object manipulation, and individuated movement of the digits. The Canadian Occupational Performance Measure (COPM) will be administered to identify goals that incorporate dexterous use of the paretic hand. Part of each training session will be used to practice these tasks, while the remainder will be used to practice component skills. Active practice will be followed by a final 10 minutes of stretching of muscles of the digits.

Treatment:

Behavioral: Occupational Therapy (OT)