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| ID | Type | Description | Link |
|---|---|---|---|
| I01RX00249 | Other Grant/Funding Number | Department of Veterans Affairs Rehab. Res. & Dev. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCFES Therapy | Active Comparator | 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. |
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| CCFES Video Game Therapy | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contralaterally Controlled Functional Electrical Stimulation (CCFES) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 weeks,12 weeks, 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 0 weeks, 12 weeks, 36 weeks |
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Inclusion Criteria:
-> 6 months since a first clinical cortical or subcortical, hemorrhagic or nonhemorrhagic stroke
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jayme S. Knutson, PhD | Louis Stokes VA Medical Center, Cleveland, OH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37962171 | Derived | Knutson JS, Fu MJ, Cunningham DA, Hisel TZ, Friedl AS, Gunzler DD, Plow EB, Busch RM, Pundik S. Contralaterally controlled functional electrical stimulation video game therapy for hand rehabilitation after stroke: a randomized controlled trial. Disabil Rehabil. 2024 Sep;46(19):4466-4475. doi: 10.1080/09638288.2023.2278174. Epub 2023 Nov 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CCFES Video Game Therapy | Custom designed hand therapy video games (HTVG) are integrated with CCFES. Surface electrodes over the paretic finger and thumb extensors delivers neuromuscular electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. The therapy regimen includes 12 weeks of CCFES-mediated: 1) home-based self-administered HTVG 10 sessions per week, and 2) lab-based therapist-guided functional task practice 20 sessions over 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2019 |
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| Hand Therapy Video Games | Device | The use of video games with CCFES to encourage therapeutic hand movement at home |
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| FG001 | CCFES Therapy | Surface electrodes over the paretic finger and thumb extensors delivers neuromuscular electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. The therapy regimen includes 12 weeks of CCFES-mediated: 1) home-based self-administered hand opening exercises 10 sessions per week, and 2) lab-based therapist-guided functional task practice 20 sessions over 12 weeks. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CCFES Video Game Therapy | Custom designed hand therapy video games (HTVG) are integrated with CCFES. Surface electrodes over the paretic finger and thumb extensors delivers neuromuscular electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. The therapy regimen includes 12 weeks of CCFES-mediated: 1) home-based self-administered HTVG 10 sessions per week, and 2) lab-based therapist-guided functional task practice 20 sessions over 12 weeks. |
| BG001 | CCFES Therapy | Surface electrodes over the paretic finger and thumb extensors delivers neuromuscular electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. The therapy regimen includes 12 weeks of CCFES-mediated: 1) home-based self-administered hand opening exercises 10 sessions per week, and 2) lab-based therapist-guided functional task practice 20 sessions over 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Years Since Stroke | Mean | Standard Deviation | years |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Least Squares Mean | Standard Error | blocks | 0 weeks,12 weeks, 36 weeks |
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| Secondary | 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) | Posted | Least Squares Mean | Standard Error | units on a scale | 0 weeks, 12 weeks, 36 weeks |
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Adverse events were collected from the time of baseline assessment (0 weeks) until the end of study participation, typically 9 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CCFES Video Game Therapy | Custom designed hand therapy video games (HTVG) are integrated with CCFES. Surface electrodes over the paretic finger and thumb extensors delivers neuromuscular electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. The therapy regimen includes 12 weeks of CCFES-mediated: 1) home-based self-administered HTVG 10 sessions per week, and 2) lab-based therapist-guided functional task practice 20 sessions over 12 weeks. | 0 | 27 | 3 | 27 | 8 | 27 |
| EG001 | CCFES Therapy | Surface electrodes over the paretic finger and thumb extensors delivers neuromuscular electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. The therapy regimen includes 12 weeks of CCFES-mediated: 1) home-based self-administered hand opening exercises 10 sessions per week, and 2) lab-based therapist-guided functional task practice 20 sessions over 12 weeks. | 0 | 25 | 2 | 25 | 7 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall leading to hospitalization | Nervous system disorders | Non-systematic Assessment |
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| Car Accident leading to hospitalization | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Infection leading to hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall not leading to hospitalization | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jayme Knutson | The MetroHealth System | 216-957-3557 | jsk12@case.edu |
| Mar 29, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 36 weeks |
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| Units | Counts |
|---|---|
| Participants |
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