Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106, United States
NCT Number: NCT03058796
Determine if adding a video game component to an electrical stimulation therapy improves hand function in stroke patients
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Notify Me21 year–80 year
All sexes
Interventional
Phase 2
Cleveland, Ohio, 44106, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-> 6 months since a first clinical cortical or subcortical, hemorrhagic or nonhemorrhagic stroke
Exclusion criteria
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.
Other names: CCFES
The use of video games with CCFES to encourage therapeutic hand movement at home
Other names: HTVG
Time frame: 0 weeks,12 weeks, 36 weeks
The Box and Blocks Test counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds.
Time frame: 0 weeks, 12 weeks, 36 weeks
The ARAT is an activity limitation measure that assesses a subject's ability to handle objects differing in size, weight and shape. Min value = 0 (least functional), Max value = 57 (most functional)
VA Office of Research and Development
Fed
Contralaterally Controlled FES Plus Video Games for Hand Therapy After Stroke
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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