Clinical trial NCT03995069: Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke
Official title: Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Hand Strength
Electromyography
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-06-21
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: baseline to within 1 week post intervention
Secondary outcomes:
Other outcomes:
measure: Box and Block Test
timeFrame: baseline to within 1 week post intervention
measure: Force Direction
timeFrame: baseline to within 1 week post intervention
measure: Action Research Arm Test
timeFrame: baseline to 1 month post intervention
measure: Box and Block Test
timeFrame: baseline to 1 month post intervention
measure: Force Direction
timeFrame: baseline to 1 month post intervention
Locations:
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
Study officials:
affiliation: Ralph H. Johnson VA Medical Center, Charleston, SC
name: Na Jin Seo, PhD MS BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.