N/A
N=45
Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT03995069 ↗Enrolled (actual)
45
Serious AEs
11.1%
Results posted
Feb 2025
Primary outcome: Primary: Action Research Arm Test (ARAT) — 3.5; 0.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 3D (Behavioral); 1D (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Action Research Arm Test (ARAT) |
3.5; 0.8 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Survived a stroke at least 3 months ago
- Moderate to severe hand impairment (Chedoke-McMaster Hand Stage 2-4)
- Ability to generate palpable volitional grip force upon cue
- Sufficient cognitive ability to participate (NIH Stroke Scale, NIHSS, Questions and Commands score = 0-1)
- Ability to recognize all quadrants of the visual field (NIHSS Visual Field Test score = 0)
Exclusion Criteria
- Concurrent upper limb rehabilitation
- Inability to follow 2-step commands
- Severe muscle tone prohibiting passive movement of the fingers or proper placement of the fingers on the force sensors as needed to participate in the training (Modified Ashworth Scale=4-5 out of 5)
- Change in spasticity medication or botulinum toxin injection in the upper limb within 3 months prior to or during enrollment
- Total sensory loss on fingertips (NIHSS Sensory score=2)
- Comorbidity (e.g., orthopaedic conditions that limit ranges of motion, premorbid neurologic conditions)
- Language barrier or cognitive impairment that precludes providing consent
Data sourced from ClinicalTrials.gov (NCT03995069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.