Ipsilesional arm training in severe stroke to improve functional independence (IPSI): phase II protocol

Abstract

Background: We previously characterized hemisphere-specific motor control deficits in the ipsilesional, less-impaired arm of unilaterally lesioned stroke survivors. Our preliminary data indicate these deficits are substantial and functionally limiting in patients with severe paresis.

Methods: We have designed an intervention ("IPSI") to remediate the hemisphere-specific deficits in the ipsilesional arm, using a virtual-reality platform, followed by manipulation training with a variety of real objects, designed to facilitate generalization and transfer to functional behaviors encountered in the natural environment. This is a 2-site (primary site - Penn State College of Medicine, secondary site - University of Southern California), two-group randomized intervention with an experimental group, which receives unilateral training of the ipsilesional arm throughout 3 one-hour sessions per week for 5 weeks, through our Virtual Reality and Manipulation Training (VRMT) protocol. Our control group receives a conventional intervention on the contralesional arm, 3 one-hour sessions per week for 5 weeks, guided by recently released practice guidelines for upper limb rehabilitation in adult stroke. The study aims to include a total of 120 stroke survivors (60 per group) whose stroke was in the territory of the middle cerebral artery (MCA) resulting in severe upper-extremity motor impairments. Outcome measures (Primary: Jebsen-Taylor Hand Function Test, Fugl-Meyer Assessment, Abilhand, Barthel Index) are assessed at five evaluation points: Baseline 1, Baseline 2, immediate post-intervention (primary endpoint), and 3-weeks (short-term retention) and 6-months post-intervention (long-term retention). We hypothesize that both groups will improve performance of the targeted arm, but that the ipsilesional arm remediation group will show greater improvements in functional independence.

Discussion: The results of this study are expected to inform upper limb evaluation and treatment to consider ipsilesional arm function, as part of a comprehensive physical rehabilitation strategy that includes evaluation and remediation of both arms.

Trial registration: This study is registered with ClinicalTrials.gov (Registration ID: NCT03634397 ; date of registration: 08/16/2018).

Keywords: Arm training; Ipsilateral deficits; Ipsilesional deficits; Less-impaired arm; Stroke motor deficits; Stroke rehabilitation; Stroke remediation; Virtual reality training.

Fig. 1

Study flow diagram from first referral to final follow-up evaluation

Fig. 2

Timeline of study events for each participant

Fig. 3

Kinematic-virtual reality set-up

Fig. 4

Ipsilesional arm therapy session activities for the experimental group

Fig. 5

Contralesional arm therapy sessions for participants randomized to the control group