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Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke
NA trial testing 3D in Stroke in 51 participants. Completed in 26 January 2024.
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 51 |
| Start date | 28 October 2020 |
| Primary completion | 26 January 2024 |
| Estimated completion | 26 January 2024 |
| Sites | 1 location across United States |
VA Office of Research and Development — full company profile →
18 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
change in a clinical assessment, ARAT, that is in a scale 0-57 with a higher score representing better upper extremity function
| Group | Value | 95% CI |
|---|---|---|
| Visual Feedback of 3D Digit Force | 3.5 | ± 0.65 |
| Visual Feedback of 1D Digit Force | 0.8 | ± 0.66 |
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
| Group | Value | 95% CI |
|---|---|---|
| Visual Feedback of 3D Digit Force | 3.03 | ± 0.97 |
| Visual Feedback of 1D Digit Force | 0.92 | ± 0.95 |
Perceived difficulty in using the affected hand for activities of daily living. Scale 0-100. A higher score represents better function (less difficulty).
| Group | Value | 95% CI |
|---|---|---|
| Visual Feedback of 3D Digit Force | 12 | ± 2 |
| Visual Feedback of 1D Digit Force | 6 | ± 2 |
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
| Group | Value | 95% CI |
|---|---|---|
| Visual Feedback of 3D Digit Force | 3.9 | ± 0.7 |
| Visual Feedback of 1D Digit Force | 0.7 | ± 0.7 |
a clinical assessment for upper extremity function.
| Group | Value | 95% CI |
|---|---|---|
| Visual Feedback of 3D Digit Force | 2.5 | ± 1 |
| Visual Feedback of 1D Digit Force | 0.5 | ± 1 |
Perceived difficulty in using the affected hand for activities of daily living. Scale 0-100. A higher score represents better function (less difficulty).
| Group | Value | 95% CI |
|---|---|---|
| Visual Feedback of 3D Digit Force | 15 | ± 2 |
| Visual Feedback of 1D Digit Force | 8 | ± 2 |
Time frame: During the study participation (approximately 10 weeks). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Visual Feedback of 3D Digi… | Visual Feedback of 1D Digi… |
|---|---|---|---|
| transient amnesia, blackout | General disorders | — | — |
| drug abuse | General disorders | — | — |
| tremor with new seizure medication | Nervous system disorders | — | — |
| car accident | General disorders | — | — |
| Reaction | System | Visual Feedback of 3D Digi… | Visual Feedback of 1D Digi… |
|---|---|---|---|
| other adverse events | General disorders | — | — |
Most-reported serious reactions: transient amnesia, blackout, drug abuse, tremor with new seizure medication, car accident.
Data from ClinicalTrials.gov NCT03995069 adverse events section.
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing