Clinical trial NCT03058796: Contralaterally Controlled Functional Electrical Stimulation Plus Video Games for Hand Therapy After Stroke
Official title: Contralaterally Controlled FES Plus Video Games for Hand Therapy After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Upper Extremity Hemiplegia
Stroke
Keywords: stroke
rehabilitation
Hemiplegia
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-02-23
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Box and Block Test Score
timeFrame: 0 weeks,12 weeks, 36 weeks
Secondary outcomes:
measure: Action Research Arm Test (ARAT) Score
timeFrame: 0 weeks, 12 weeks, 36 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center, Cleveland, OH
state: Ohio
Study officials:
affiliation: Louis Stokes VA Medical Center, Cleveland, OH
name: Jayme S. Knutson, PhD
role: PRINCIPAL_INVESTIGATOR
References: