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.

Abstract

Background: Functional task performance requires proper control of both movement and force generation in three-dimensional space, especially for the hand. Control of force in three dimensions, however, is not explicitly treated in current physical rehabilitation. To address this gap in treatment, we have developed a tool to provide visual feedback on three-dimensional finger force. Our objective is to examine the effectiveness of training with this tool to restore hand function in stroke survivors.

Methods: Double-blind randomized controlled trial. All participants undergo 18 1-h training sessions to practice generating volitional finger force of various target directions and magnitudes. The experimental group receives feedback on both force direction and magnitude, while the control group receives feedback on force magnitude only. The primary outcome is hand function as measured by the Action Research Arm Test. Other outcomes include the Box and Block Test, Stroke Impact Scale, ability to direct finger force, muscle activation pattern, and qualitative interviews.

Discussion: The protocol for this clinical trial is described in detail. The results of this study will reveal whether explicit training of finger force direction in stroke survivors leads to improved motor control of the hand. This study will also improve the understanding of neuromuscular mechanisms underlying the recovery of hand function.

Trial registration: ClinicalTrials.gov NCT03995069 . Registered on June 21, 2019.

Keywords: Biofeedback; Control; EMG; Grip force; Hand function; Paralysis; Physical rehabilitation; Randomized controlled trial; Stroke; Upper extremity.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Hand
  • Humans
  • Randomized Controlled Trials as Topic
  • Recovery of Function
  • Stroke Rehabilitation* / methods
  • Stroke* / diagnosis
  • Stroke* / therapy
  • Treatment Outcome
  • Upper Extremity

Associated data

  • ClinicalTrials.gov/NCT03995069