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Despite the functional importance, fingertip forces are rarely explicitly addressed with feedback in therapy. This gap in treatment is due to a lack of tools to provide explicit feedback on patients' volitional finger force generation. To address this unmet need, the investigators developed a novel tool for practice of volitional three-dimensional (3D) force generation with explicit feedback. The objective of this project is to determine if 3D finger force training is an effective tool in restoring hand function post stroke.
Despite the functional importance, fingertip forces are rarely explicitly addressed with feedback in therapy. This gap in treatment is due to a lack of tools to provide explicit feedback on patients' volitional finger force generation. To address this unmet need, the investigators developed a novel tool for practice of volitional three-dimensional (3D) force generation with explicit feedback. The objective of this project is to determine if 3D finger force training is an effective tool in restoring hand function post stroke.
Stroke survivors with moderate to severe hand impairment with at least palpable volitional grip force will randomly be assigned to either the experimental or control group, stratified by impairment level. Both groups will undergo 3 1-hr training sessions per week for 6 weeks in which they practice volitional finger force generation against force sensors. The experimental group will practice for various target force directions to explore the 3D force workspace and receive feedback in 3D force, while the control group will practice 1D force generation without feedback on other directional forces on a computer screen.
Training will progress by increasing influence of flexion synergy by varying posture requirements and increasing force level, introducing feedback delay, and incorporating unilateral/bilateral activity. Evaluation will occur at baseline (3 times over 3 weeks to establish baseline trends) and every 2 weeks during 6-week intervention to determine pattern of progress, and at 1-month follow-up to assess retention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D | Experimental | The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen. |
|
| 1D | Active Comparator | The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D | Behavioral | Practice generating grip force to the target shown on the computer screen in 3 dimensions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Action Research Arm Test (ARAT) | change in a clinical assessment, ARAT, that is in a scale 0-57 with a higher score representing better upper extremity function | baseline to within 1 week post intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Box and Block Test | a clinical assessment measuring the number of blocks that a person can move in a minute, with a higher score representing better upper extremity function | baseline to within 1 week post intervention |
| Stroke Impact Scale Hand Subscale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Na Jin Seo, PhD MS BS | Ralph H. Johnson VA Medical Center, Charleston, SC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ralph H. Johnson VA Medical Center, Charleston, SC | Charleston | South Carolina | 29401-5703 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40401398 | Derived | Seo NJ, Schranz C, Coupland K, Blaschke J, Scronce G, Finetto C, Baker A, Gallant J, Alston A, Howard K, Thompson D, Ramakrishnan V, Holmstedt CA, Kamper DG. Biofeedback Training for 3-Dimensional Finger Force Control to Improve Upper Limb Function Poststroke: An RCT. Stroke. 2025 Aug;56(8):2266-2276. doi: 10.1161/STROKEAHA.125.050965. Epub 2025 May 22. | |
| 35413931 |
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De-identified individual data will be shared as a supplement of a publication in peer reviewed journals if allowed by the journal, and also upon written request.
During the study period and 5 years post study completion
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Not meeting inclusion criteria (n=1) Declined to participate (n=3) Funding ended (n=2)
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| ID | Title | Description |
|---|---|---|
| FG000 | Visual Feedback of 3D Digit Force | The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen. 3D: Practice generating grip force to the target shown on the computer screen in 3 dimensions. |
| FG001 | Visual Feedback of 1D Digit Force | The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen. 1D: Practice generating grip force to the target shown on the computer screen in 1 dimension. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Visual Feedback of 3D Digit Force | The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen. 3D: Practice generating grip force to the target shown on the computer screen in 3 dimensions. |
| BG001 | Visual Feedback of 1D Digit Force |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Action Research Arm Test (ARAT) | change in a clinical assessment, ARAT, that is in a scale 0-57 with a higher score representing better upper extremity function | Posted | Mean | Standard Error | score on a scale | baseline to within 1 week post intervention |
|
During the study participation (approximately 10 weeks)
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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 | Visual Feedback of 3D Digit Force | The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen. 3D: Practice generating grip force to the target shown on the computer screen in 3 dimensions. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| drug abuse | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| other adverse events | General disorders | Systematic Assessment | high blood pressure, dog bite, sore throat, fatigue, pain, etc. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Ralph H. Johnson VA Health Care System | 8434671373 | NaJin.Seo@va.gov |
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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 | Jun 23, 2022 | Dec 3, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 7, 2022 | Jan 21, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 1D | Behavioral | Practice generating grip force to the target shown on the computer screen in 1 dimension. |
|
Perceived difficulty in using the affected hand for activities of daily living. Scale 0-100. A higher score represents better function (less difficulty).
| baseline to within 1 week post intervention |
| Action Research Arm Test | change in a clinical assessment of Action Research Arm Test that is in a scale 0-57 with a higher score representing better upper extremity function | baseline to 1 month post intervention |
| Box and Block Test | a clinical assessment for upper extremity function. | baseline to 1 month post intervention |
| Stroke Impact Scale Hand Subscale | Perceived difficulty in using the affected hand for activities of daily living. Scale 0-100. A higher score represents better function (less difficulty). | baseline to 1 month post intervention |
| Seo NJ, Kamper DG, Ramakrishnan V, Harvey JB, Finetto C, Schranz C, Scronce G, Coupland K, Howard K, Blaschke J, Baker A, Meinzer C, Velozo CA, Adams RJ. Effect of novel training to normalize altered finger force direction post-stroke: study protocol for a double-blind randomized controlled trial. Trials. 2022 Apr 12;23(1):301. doi: 10.1186/s13063-022-06224-w. |
The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen. 1D: Practice generating grip force to the target shown on the computer screen in 1 dimension. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Other Pre-specified | Box and Block Test | a clinical assessment measuring the number of blocks that a person can move in a minute, with a higher score representing better upper extremity function | Posted | Mean | Standard Error | blocks moved in 1 min | baseline to within 1 week post intervention |
|
|
|
| Other Pre-specified | Stroke Impact Scale Hand Subscale | Perceived difficulty in using the affected hand for activities of daily living. Scale 0-100. A higher score represents better function (less difficulty). | Posted | Mean | Standard Error | score on a scale | baseline to within 1 week post intervention |
|
|
|
| Other Pre-specified | Action Research Arm Test | change in a clinical assessment of Action Research Arm Test that is in a scale 0-57 with a higher score representing better upper extremity function | Posted | Mean | Standard Error | score on a scale | baseline to 1 month post intervention |
|
|
|
| Other Pre-specified | Box and Block Test | a clinical assessment for upper extremity function. | Posted | Mean | Standard Error | blocks moved in 1 min | baseline to 1 month post intervention |
|
|
|
| Other Pre-specified | Stroke Impact Scale Hand Subscale | Perceived difficulty in using the affected hand for activities of daily living. Scale 0-100. A higher score represents better function (less difficulty). | Posted | Mean | Standard Error | score on a scale | baseline to 1 month post intervention |
|
|
|
| 0 |
| 22 |
| 2 |
| 22 |
| 18 |
| 22 |
| EG001 | Visual Feedback of 1D Digit Force | The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen. 1D: Practice generating grip force to the target shown on the computer screen in 1 dimension. | 0 | 23 | 3 | 23 | 18 | 23 |
| tremor with new seizure medication | Nervous system disorders | Non-systematic Assessment |
|
| car accident | General disorders | Non-systematic Assessment |
|
| transient amnesia, blackout | General disorders | Non-systematic Assessment |
|
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |