NCT03058796

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

Contralaterally Controlled FES Plus Video Games for Hand Therapy After Stroke

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Upper Extremity Hemiplegia
• Stroke

Interventions

Type	Name	Description
DEVICE	Contralaterally Controlled Functional Electrical Stimulation (CCFES)	The use of surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. 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.
DEVICE	Hand Therapy Video Games	The use of video games with CCFES to encourage therapeutic hand movement at home

Timeline

• Start date: 2017-06-19
• Primary completion: 2022-06-13
• Completion: 2022-09-30
• First posted: 2017-02-23
• Last updated: 2024-01-05
• Results posted: 2024-01-05

Locations

1 site across 1 country: United States