Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke

NCT03995069 | Completed Results DMC

• 1 other identifier: A3066-R
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Hand Strength; Electromyography

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (5)

• Box and Block Test

  baseline to within 1 week post intervention

• Stroke Impact Scale Hand Subscale

  baseline to within 1 week post intervention

• Action Research Arm Test

  baseline to 1 month post intervention

Study Arms (2)

3D

EXPERIMENTAL

The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.

Behavioral: 3D

1D

ACTIVE COMPARATOR

The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen.

Behavioral: 1D

Interventions

3D BEHAVIORAL

Practice generating grip force to the target shown on the computer screen in 3 dimensions.

3D

1D BEHAVIORAL

Practice generating grip force to the target shown on the computer screen in 1 dimension.

1D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

Location

Related Publications (2)

• 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.

  PMID: 40401398 DERIVED

• 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.

  PMID: 35413931 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Principal Investigator
• Organization: Ralph H. Johnson VA Health Care System

NaJin.Seo@va.gov

8434671373

Study Officials

• Na Jin Seo, PhD MS BS

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 21, 2019
• Study Start: October 28, 2020
• Primary Completion: January 26, 2024
• Study Completion: January 26, 2024
• Last Updated: July 11, 2025
• Results First Posted: February 14, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: During the study period and 5 years post study completion

Locations

US (1)