Contralaterally Controlled Functional Electrical Stimulation Plus Video Games for Hand Therapy After Stroke

VA Office of Research and Development

Status and phase: Completed; Phase 2

Conditions: Stroke; Upper Extremity Hemiplegia

Treatments: Device: Hand Therapy Video Games; Device: Contralaterally Controlled Functional Electrical Stimulation (CCFES)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03058796

I01RX00249 (Other Grant/Funding Number)

N2249-R

Details and patient eligibility

About

Determine if adding a video game component to an electrical stimulation therapy improves hand function in stroke patients

Full description

A single-blinded randomized controlled trial will be carried out to assess the effects of 12 weeks of Contralaterally Controlled Functional Electrical Stimulation (CCFES) +Hand Therapy Video Games (HTVG) compared to CCFES. Dexterity and activity limitation will be assessed at 0 (baseline), 12 (end of treatment), and 36 (6 months follow-up) wks. The planned treatment dose will be the same for both groups: 10 sessions per week of self-administered treatment at home plus 20 sessions of group-specific occupational therapy in the lab over 12 weeks.

Enrollment: 52 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-> 6 months since a first clinical cortical or subcortical, hemorrhagic or nonhemorrhagic stroke

• age 21-80 years old
• unilateral upper limb hemiparesis with finger extensor strength of grade <=4/5 on the Medical Research Council (MRC) scale AND a score of >=1 and <=11/14 on the hand section of the upper extremity Fugl-Meyer Assessment
• adequate active movement of the shoulder and elbow to position the hand in the workspace for table-top task practice (necessary for the lab task practice sessions)
• able to follow 3-stage commands
• able to recall 2 of 3 words after 30 minutes
• surface stimulation of the paretic finger and thumb extensors produces functional hand opening without pain (this will exclude those who have degree of flexor hypertonia that prevents stimulated hand opening)
• Functional passive range of motion (minimal resistance) at elbow, wrist, fingers, and thumb, i.e., there exists enough passive range of motion to reach and acquire table-top objects
• intact vision and hearing
• medically stable
• full voluntary opening/closing of the contralateral (less affected) hand
• demonstrate ability to follow instructions for operating the stimulator or have a caregiver who will assist them

Exclusion criteria

• co-existing neurologic diagnosis of peripheral nerve injury, Parkinson's disease, spinal cord injury, traumatic brain injury, or multiple sclerosis
• uncontrolled seizure disorder
• severely impaired cognition and communication
• uncompensated hemineglect
• arm or forearm skin breakdown or edema (to avoid edema-related shunting of current)
• insensate forearm (to avoid risk of electrical burns)
• history of potentially fatal cardiac arrhythmias with hemodynamic instability
• implanted electronic systems (e.g. pacemaker)
• botulinum toxin injections to any upper extremity muscle within 3 months of enrolling
• pregnant women due to unknown risks of surface stimulation during pregnancy
• participating in occupational therapy or other rehabilitation therapies to the upper extremity
• severe shoulder or hand pain

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

CCFES Therapy

Active Comparator group

Description:

CCFES uses surface electrodes over the paretic finger and thumb extensors to deliver stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. Thus, volitional opening of the nonparetic hand produces stimulated opening of the paretic hand. CCFES enables stroke survivors to open and close their paretic hand and practice using it in therapy sessions. The treatment regimen includes CCFES-mediated: 1) home-based self-administered hand opening exercises, and 2) lab-based therapist-guided functional task practice.

Treatment:

Device: Contralaterally Controlled Functional Electrical Stimulation (CCFES)

CCFES Video Game Therapy

Experimental group

Description:

CCFES Video Game Therapy integrates custom designed hand therapy video games with CCFES which enables participants to use the video game component at home instead of repetitive hand opening exercises.

Treatment:

Device: Hand Therapy Video Games

Device: Contralaterally Controlled Functional Electrical Stimulation (CCFES)