A Phase 2 interventional study of Contralaterally Controlled Functional Electrical Stimulation (CCFES) and Hand Therapy Video Games in Upper Extremity Hemiplegia and Stroke, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-01-05.
Sponsored by VA Office of Research and Development · Phase 2, Interventional, and Treatment
Determine if adding a video game component to an electrical stimulation therapy improves hand function in stroke patients
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 52 is close to the median of 50 across 5,369 interventional studies indexed under Stroke.
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-> 6 months since a first clinical cortical or subcortical, hemorrhagic or nonhemorrhagic stroke
Exclusion Criteria:
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.
Device: Contralaterally Controlled Functional Electrical Stimulation (CCFES)
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.
Device: Contralaterally Controlled Functional Electrical Stimulation (CCFES) · Device: Hand Therapy Video Games
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.
Also known as: CCFES
The use of video games with CCFES to encourage therapeutic hand movement at home
Also known as: HTVG
Box and Block Test Score
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
Action Research Arm Test (ARAT) Score
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)
Time frame: 0 weeks, 12 weeks, 36 weeks
| Milestone | CCFES Video Game Therapy | CCFES Therapy |
|---|---|---|
| Started | 27 | 25 |
| Completed | 18 | 21 |
| Not completed | 9 | 4 |
The Box and Blocks Test counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds.
| blocks | CCFES Video Game Therapy | CCFES Therapy |
|---|---|---|
| 0 weeks | 10.6 ± 2.6 | 11.0 ± 2.6 |
| 12 weeks | 11.2 ± 2.8 | 12.4 ± 2.8 |
| 36 weeks | 11.1 ± 2.7 | 11.6 ± 2.6 |
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)
| units on a scale | CCFES Video Game Therapy | CCFES Therapy |
|---|---|---|
| 0 weeks | 19.4 ± 3.6 | 19.0 ± 2.6 |
| 12 weeks | 18.6 ± 3.5 | 21.2 ± 2.8 |
| 36 weeks | 18.8 ± 3.7 | 20.6 ± 2.8 |
Collected over Adverse events were collected from the time of baseline assessment (0 weeks) until the end of study participation, typically 9 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CCFES Video Game Therapy | 0/27 (0%) | 3/27 (11.1%) | 8/27 (29.6%) |
| CCFES Therapy | 0/25 (0%) | 2/25 (8%) | 7/25 (28%) |
| Event | CCFES Video Game Therapy | CCFES Therapy |
|---|---|---|
| Fall leading to hospitalizationNervous system disorders | 2/27 | 1/25 |
| Infection leading to hospitalizationRespiratory, thoracic and mediastinal disorders | 0/27 | 1/25 |
| Car Accident leading to hospitalizationMusculoskeletal and connective tissue disorders | 1/27 | 0/25 |
| Event | CCFES Video Game Therapy | CCFES Therapy |
|---|---|---|
| Fall not leading to hospitalizationNervous system disorders | 8/27 | 7/25 |
| Age, Continuous(years) | CCFES Video Game Therapy | CCFES Therapy | Total |
|---|---|---|---|
| Mean | 60 ± 11 | 62 ± 11 | 61 ± 10 |
| Sex: Female, Male(Participants) | CCFES Video Game Therapy | CCFES Therapy | Total |
|---|---|---|---|
| Female | 9 | 10 | 19 |
| Male | 18 | 15 | 33 |
| Race (NIH/OMB)(Participants) | CCFES Video Game Therapy | CCFES Therapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 12 | 10 | 22 |
| White | 12 | 12 | 24 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Years Since Stroke(years) | CCFES Video Game Therapy | CCFES Therapy | Total |
|---|---|---|---|
| Mean | 5 ± 4.5 | 3.9 ± 3.4 | 4.5 ± 4.0 |
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