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The Early and Intensive Motor Training for Spinal Cord Injury Trial: key principles to consider when undertaking large international investigator-driven clinical trials.

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International Spinal Cord Injury Physical Therapy-Occupational Therapy Basic Data Set (Version 1.2).

Kim D Anderson1,2, Edelle C Field-Fote3,4,5, Fin Biering-Sørensen6

  • 1MetroHealth Rehabilitation Institute, MetroHealth System, Cleveland, OH, USA. kxa304@case.edu.

Spinal Cord Series and Cases
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Summary

A new International Spinal Cord Injury Physical Therapy-Occupational Therapy Basic Data Set standardizes documentation for clinical trials. This tool helps evaluate rehabilitation therapies

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Area of Science:

  • Rehabilitation medicine
  • Clinical trial methodology
  • Neuroscience

Background:

  • Standardized documentation of physical therapy (PT) and occupational therapy (OT) interventions is crucial for clinical trials evaluating motor function recovery in spinal cord injury (SCI).
  • Existing documentation methods may lack uniformity, hindering comparative analysis across studies.
  • A need exists for a practical and efficient data set to capture PT-OT interventions in SCI research.

Purpose of the Study:

  • To develop and refine a basic data set for standardized documentation of PT and OT interventions in SCI clinical trials.
  • To create a tool that facilitates the evaluation of rehabilitation therapies aimed at improving voluntary motor function.
  • To ensure the dataset is efficient and practical for use in clinical settings.

Main Methods:

  • An international working group of experts in SCI, PT, OT, and measurement was convened.
  • The International Spinal Cord Injury (ISCI) Physical Therapy-Occupational Therapy (PT-OT) Basic Data Set (BDS) was drafted.
  • The BDS was iteratively refined using literature reviews and feedback from international SCI conferences (2017, 2019).

Main Results:

  • The ISCI PT-OT BDS includes seven intervention categories: bed/seated mobility, standing activities, walking/stairs, gross and fine motor upper extremity, strength training, and endurance training.
  • Interventions are classified as activity-directed (first five categories) or impairment-directed (last two).
  • Time spent on interventions is recorded in 15-minute intervals.

Conclusions:

  • The ISCI PT-OT BDS provides a standardized method for documenting PT-OT interventions in SCI clinical trials.
  • This data set supports the evaluation of rehabilitation therapies' impact on motor function.
  • The BDS is a valuable documentation tool for research involving biologic, pharmacologic, or technological interventions for SCI.