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Phase 2 N=52 Randomized Single-blind Treatment

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

Upper Extremity Hemiplegia · Stroke

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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