Phase 2
N=52
Contralaterally Controlled Functional Electrical Stimulation Plus Video Games for Hand Therapy After Stroke
Upper Extremity Hemiplegia · Stroke
Bottom Line
View on ClinicalTrials.gov: NCT03058796 ↗Enrolled (actual)
52
Serious AEs
9.6%
Results posted
Jan 2024
Primary outcome: Primary: Box and Block Test Score — 10.6; 11.0; 11.2; 12.4 blocks
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Contralaterally Controlled Functional Electrical Stimulation (CCFES) (Device); Hand Therapy Video Games (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Box and Block Test Score |
10.6; 11.0; 11.2; 12.4; 11.1; 11.6 | — |
| SECONDARY Action Research Arm Test (ARAT) Score |
19.4; 19.0; 18.6; 21.2; 18.8; 20.6 | — |
Summary
Determine if adding a video game component to an electrical stimulation therapy improves hand function in stroke patients
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 =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
Data sourced from ClinicalTrials.gov (NCT03058796). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.