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Chronic Stroke Outcome Measures for Motor Function Intervention Trials: Expert Panel Recommendations.

Cheryl Bushnell1, Janet Prvu Bettger1, Kevin M Cockroft1

  • 1From the Department of Neurology, Wake Forest Baptist Medical Center, Winston-Salem, NC (C.B.); Duke University School of Nursing, Durham, NC (J.P.B.); Department of Neurosurgery, Radiology and Public Health Sciences, Pennsylvania State University, Hershey (K.M.C.); Department of Neurology (S.C.C.) and Anatomy and Neurobiology (S.C.C.), University of California, Irvine; RAND Health Advisory Services, RAND Corporation, Boston, MA (M.O.E., S.M.); Department of Neurology (D.H.) and Department of Biostatistics, Bloomberg School of Public Health (G.Y.), Johns Hopkins University Medical Center, Baltimore, MD; Center for Outcomes Research and Evaluation, Cleveland Clinic, Cleveland, OH (I.K.); Department of Rehabilitation and Regenerative Medicine (Occupational Therapy), Columbia University Medical Center, New York, NY (D.M.N.); RAND Health Advisory Services, RAND Corporation, Santa Monica, CA (T.P.); Department of Occupational Therapy, University of Pittsburgh, Pittsburgh, PA (E.R.S.); and South West Advanced Neurological Rehabilitation, LLC, Phoenix, AZ (K.W.).

Circulation. Cardiovascular Quality and Outcomes
|October 31, 2015
PubMed
Summary

For chronic stroke survivors, the Fugl-Meyer scales are recommended as primary outcomes for motor function trials. Other validated measures serve as important secondary outcomes for assessing recovery and function.

Keywords:
chronic diseaselower extremitystrokesuvivorsupper extremity

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Area of Science:

  • Neurorehabilitation
  • Clinical Trial Methodology
  • Patient-Reported Outcomes

Background:

  • Stroke survivors frequently experience significant long-term motor disability.
  • Measuring patient-centric outcomes is crucial for effective chronic stroke rehabilitation interventions.

Purpose of the Study:

  • To review current scientific literature on outcome measures for motor improvement in chronic stroke.
  • To provide recommendations for selecting patient-centric outcome measures in clinical trials.

Main Methods:

  • An expert panel systematically reviewed 115 clinical trials involving upper and lower extremity function in chronic stroke.
  • Outcome measures were evaluated based on StrokEDGE recommendations, minimal clinically important differences, psychometric properties, and clinical relevance.
  • Seven measures with published minimal clinically important differences were identified and assessed.

Main Results:

  • The Fugl-Meyer Upper Extremity and Lower Extremity scales, Wolf Motor Function Test, Action Research Arm Test, Ten-Meter and Six-Minute Walk Tests, and Stroke Impact Scale were identified.
  • The Fugl-Meyer scales demonstrated the strongest evidence for validity in chronic stroke populations.
  • All identified measures showed evidence of psychometric performance, though validity evidence varied.

Conclusions:

  • The Fugl-Meyer Upper Extremity and Lower Extremity scales are recommended as primary outcome measures for motor function trials in chronic stroke.
  • The remaining six identified measures are recommended for use as secondary outcomes in these trials.