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

Not yet recruiting

Phase 2 Results N/A

Trial Description

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, upper limb impairment, and activity limitation will be assessed at 0 (baseline), 3, 6, 9, 12 (end of treatment), 24, and 36 wks. Cortical activation (measured with fMRI) will be assessed at 0 and 12 wks. The treatment dose will be the same for both groups: 10 sessions per week (7.5 hrs) of self-administered treatment at home plus 2 sessions per week (3 hrs) of group-specific occupational therapy in the lab.

Conditions

Interventions

  • Neuromuscular electrical stimulation (NMES) Device
    Other Names: NMES
    Intervention Desc: The use of electrical current to activate paretic muscles through surface electrodes.
    ARM 1: Kind: Experimental
    Label: CCFES
    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.
    ARM 2: Kind: Experimental
    Label: CCFES Video Game Therapy
    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.
  • Hand Therapy Video Games Device
    Other Names: HTVG
    Intervention Desc: The use of video games with NMES to encourage therapeutic hand movement at home
    ARM 1: Kind: Experimental
    Label: CCFES Video Game Therapy
    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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Box and Block Test change Baseline 3,6,9,12,24 and 36 weeks
Secondary Arm Motor Abilities Test (AMAT) change Baseline 3,6,9,12,24 and 36 weeks

Sponsors