Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke (NEAD)

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: 3D; Behavioral: 1D

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29401-5703
      • Ralph H. Johnson VA Medical Center, Charleston, SC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D; The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.	Behavioral: 3D; Practice generating grip force to the target shown on the computer screen in 3 dimensions.
Active Comparator: 1D; The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen.	Behavioral: 1D; Practice generating grip force to the target shown on the computer screen in 1 dimension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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
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 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
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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Na Jin Seo, PhD MS BS, Ralph H. Johnson VA Medical Center, Charleston, SC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2020
• Primary Completion (Actual): January 26, 2024
• Study Completion (Actual): January 26, 2024

Study Registration Dates

• First Submitted: June 19, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: June 20, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Electromyography; Hand Strength
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: A3066-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: During the study period and 5 years post study completion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No