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

For the IPSI Investigative Team

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

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).

Original languageEnglish (US)
Article number141
JournalBMC neurology
Volume22
Issue number1
DOIs
StatePublished - Dec 2022
Externally publishedYes

Bibliographical note

Funding Information:
This study is funded by NIH grant (2 R01 HD059783-06A1) received as part of a competitive renewal of an R01 awarded to Sainburg-PI. The funding body did not play any role in the design of the study and collection, analysis, and interpretation of data or in writing the manuscript.

Funding Information:
This work is supported by funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (2 R01 HD059783-06A1). The authors would like to acknowledge the contributions of the following members of the IPSI Investigative team: We thank current and former members of the study personnel for their contributions to the manuscript, study discussions, and study implementation (PSU: Nick Kitchen (post-doctoral scholar), Kristen Selby (research assistant), Alison Celigoi (former PSU CSC); USC: Brianna Chang (USC CSC), Jaya George (former USC CSC), Jessica Goytizolo (former USC Interventionist). We thank neurological consultants Dr. Lakshmi Shankar and Dr. David Good. We thank additional study personnel involved in data protocol delivery, including occupational therapists at PSU, Pamela Hudson, Jana Poole, Zahira Paul, Arlisa Hoover, and PSU CSC Jordan Sellers. We thank Jacqueline Lin (former USC Interventionist), Amelia Cain (USC Interventionist), Nicolo Betoni (former USC Research Assistant), Susmitha Varghese (former USC CSC), Camila Torriani-Pasin (former Blinded Assessor), and Beverly Weithman (former USC Interventionist) for their contributions to the IPSI trial. We thank the Data Safety and Monitoring Board: Dr. William Pomilla, (DSMB Chair), Dr. David Wagstaff (former DSMB liaison and biostatistician), John Graybeal, Dr. Nerses Sanossian and Dr. Ramzi Ben-Youssef and Dr. David Gator (former DSMB Chair). Our study biostatistician, David Wagstaff passed away prior to the publication of this manuscript, but his contributions were instrumental to the study.

Funding Information:
This work is supported by funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (2 R01 HD059783-06A1). The authors would like to acknowledge the contributions of the following members of the IPSI Investigative team: We thank current and former members of the study personnel for their contributions to the manuscript, study discussions, and study implementation (PSU: Nick Kitchen (post-doctoral scholar), Kristen Selby (research assistant), Alison Celigoi (former PSU CSC); USC: Brianna Chang (USC CSC), Jaya George (former USC CSC), Jessica Goytizolo (former USC Interventionist). We thank neurological consultants Dr. Lakshmi Shankar and Dr. David Good. We thank additional study personnel involved in data protocol delivery, including occupational therapists at PSU, Pamela Hudson, Jana Poole, Zahira Paul, Arlisa Hoover, and PSU CSC Jordan Sellers. We thank Jacqueline Lin (former USC Interventionist), Amelia Cain (USC Interventionist), Nicolo Betoni (former USC Research Assistant), Susmitha Varghese (former USC CSC), Camila Torriani-Pasin (former Blinded Assessor), and Beverly Weithman (former USC Interventionist) for their contributions to the IPSI trial. We thank the Data Safety and Monitoring Board: Dr. William Pomilla, (DSMB Chair), Dr. David Wagstaff (former DSMB liaison and biostatistician), John Graybeal, Dr. Nerses Sanossian and Dr. Ramzi Ben-Youssef and Dr. David Gator (former DSMB Chair). Our study biostatistician, David Wagstaff passed away prior to the publication of this manuscript, but his contributions were instrumental to the study.

Funding Information:
Please note, because the protocol described here was funded with grant monies (2 R01 HD059783-06A1) received as part of a competitive renewal of an R01 (Sainburg PI), the title of this protocol differs from the grant proposal title (Predicting Ipsilesional Motor Deficits in Stroke with Dynamic Dominance Model).

Publisher Copyright:
© 2022, The Author(s).

Keywords

  • Arm training
  • Ipsilateral deficits
  • Ipsilesional deficits
  • Less-impaired arm
  • Stroke motor deficits
  • Stroke rehabilitation
  • Stroke remediation
  • Virtual reality training

Fingerprint

Dive into the research topics of 'Ipsilesional arm training in severe stroke to improve functional independence (IPSI): phase II protocol'. Together they form a unique fingerprint.

Cite this