Estimating the minimal clinically important difference of upper extremity outcome measures in chronic stroke patients with moderate to severe impairment: a cross-sectional study

ABSTRACT Background Approximately 70% of chronic stroke patients experience upper extremity (UE) functional impairments, and UE outcome measures are often used as quality-of-life indicators. Objective The purpose of this study was to estimate minimal clinically important difference (MCID) values for UE outcome measures in chronic stroke patients with moderate to severe UE hemiplegia. Methods This study was a cross-sectional study, conducted as a secondary analysis of data from the ReoGo-J study, a multicenter, prospective, randomized, parallel-group trial of robot-assisted self-training for UE hemiplegia in chronic stroke. The patients were randomized to 1 of 3 treatment groups. Treatment was provided 3 times a week for 10 weeks, and UE outcome measures were evaluated before and after treatment. The anchor-based method was used to estimate MCID values for UE outcome measures, with Stroke Impact Scale (SIS) subscales as anchors. MCID values were estimated by identifying cutoff values in a receiver operating characteristic (ROC) curve. Results Between-group comparisons of UE outcome measures, based on the clinically important difference (CID) values of SIS subscales, revealed significant differences in both the Amount of Use (AOU) and Quality of Movement (QOM) components of the Motor Activity Log (MAL)-14. The estimated MCID values were 0.89 for the AOU component and 0.77 for the QOM component. Conclusions The estimated MCID values for the MAL-14 not only add information regarding the clinical characteristics of the MAL-14 but also facilitate interpretations of changing scores in chronic stroke patients with moderate to severe UE hemiplegia undergoing rehabilitation therapy. Study registration https://www.umin.ac.jp/ctr/index.htm (UMIN000022509; 1 July 2016).

[1]  K. Domen,et al.  Robot-Assisted Training as Self-Training for Upper-Limb Hemiplegia in Chronic Stroke: A Randomized Controlled Trial , 2022, Stroke.

[2]  Lynne V. Gauthier,et al.  Improved quality of life following constraint-induced movement therapy is associated with gains in arm use, but not motor improvement , 2018, Topics in stroke rehabilitation.

[3]  Kenji Hachisuka,et al.  Assessment of the Efficacy of ReoGo-J Robotic Training Against Other Rehabilitation Therapies for Upper-Limb Hemiplegia After Stroke: Protocol for a Randomized Controlled Trial , 2018, Front. Neurol..

[4]  K. Domen,et al.  Clinimetric properties of the Fugl-Meyer assessment with adapted guidelines for the assessment of arm function in hemiparetic patients after stroke , 2018, Topics in stroke rehabilitation.

[5]  K. Domen,et al.  Reliability of remote evaluation for the Fugl–Meyer assessment and the action research arm test in hemiparetic patients after stroke , 2018, Topics in stroke rehabilitation.

[6]  S. Page,et al.  Clinically Important Differences for the Upper-Extremity Fugl-Meyer Scale in People With Minimal to Moderate Impairment Due to Chronic Stroke , 2012, Physical Therapy.

[7]  C. Winstein,et al.  Minimal Detectable Change of the Actual Amount of Use Test and the Motor Activity Log , 2012, Neurorehabilitation and neural repair.

[8]  Rajesh Verma,et al.  Estimating the Minimal Clinically Important Difference of an Upper Extremity Recovery Measure in Subacute Stroke Patients , 2011, Topics in stroke rehabilitation.

[9]  Yen-ho Wang,et al.  Minimal Detectable Change and Clinically Important Difference of the Stroke Impact Scale in Stroke Patients , 2010, Neurorehabilitation and neural repair.

[10]  Hermano I Krebs,et al.  Multicenter Randomized Trial of Robot-Assisted Rehabilitation for Chronic Stroke: Methods and Entry Characteristics for VA ROBOTICS , 2009, Neurorehabilitation and neural repair.

[11]  S. Stanhope,et al.  Community-Based Adaptive Physical Activity Program for Chronic Stroke: Feasibility, Safety, and Efficacy of the Empoli Model , 2009, Neurorehabilitation and neural repair.

[12]  Ching-yi Wu,et al.  Constraint-Induced Therapy Versus Dose-Matched Control Intervention to Improve Motor Ability, Basic/Extended Daily Functions, and Quality of Life in Stroke , 2009, Neurorehabilitation and neural repair.

[13]  C. Lang,et al.  Estimating minimal clinically important differences of upper-extremity measures early after stroke. , 2008, Archives of physical medicine and rehabilitation.

[14]  J. Dewald,et al.  Augmenting Clinical Evaluation of Hemiparetic Arm Movement With a Laboratory-Based Quantitative Measurement of Kinematics as a Function of Limb Loading , 2008, Neurorehabilitation and neural repair.

[15]  S. Lydersen,et al.  Short- and long-term outcome of constraint-induced movement therapy after stroke: a randomized controlled feasibility trial , 2008, Clinical rehabilitation.

[16]  K. Cain,et al.  Living well with stroke: design and methods for a randomized controlled trial of a psychosocial behavioral intervention for poststroke depression. , 2008, Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association.

[17]  D. Leys,et al.  Sex Differences in Quality of Life in Stroke Survivors: Data From the Tinzaparin in Acute Ischaemic Stroke Trial (TAIST) , 2007, Stroke.

[18]  Ching-yi Wu,et al.  A randomized controlled trial of modified constraint-induced movement therapy for elderly stroke survivors: changes in motor impairment, daily functioning, and quality of life. , 2007, Archives of physical medicine and rehabilitation.

[19]  J. P. Miller,et al.  Effect of constraint-induced movement therapy on upper extremity function 3 to 9 months after stroke: the EXCITE randomized clinical trial. , 2006, JAMA.

[20]  Pamela W. Duncan,et al.  Issues in selecting outcome measures to assess functional recovery after stroke , 2006, NeuroRX.

[21]  S. Haley,et al.  Interpreting change scores of tests and measures used in physical therapy. , 2006, Physical therapy.

[22]  E. Taub,et al.  Reliability and Validity of the Upper-Extremity Motor Activity Log-14 for Measuring Real-World Arm Use , 2005, Stroke.

[23]  S. Studenski,et al.  Daily Functioning and Quality of Life in a Randomized Controlled Trial of Therapeutic Exercise for Subacute Stroke Survivors , 2005, Stroke.

[24]  C. Bombardier,et al.  Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement , 2004, Annals of the rheumatic diseases.

[25]  H. Vet,et al.  Clinimetric Properties of the Motor Activity Log for the Assessment of Arm Use in Hemiparetic Patients , 2004, Stroke.

[26]  Subashan Perera,et al.  Rasch analysis of a new stroke-specific outcome scale: the Stroke Impact Scale. , 2003, Archives of physical medicine and rehabilitation.

[27]  D. Cella,et al.  Meaningful change in cancer-specific quality of life scores: Differences between improvement and worsening , 2002, Quality of Life Research.

[28]  J. H. van der Lee,et al.  Forced use of the upper extremity in chronic stroke patients: results from a single-blind randomized clinical trial. , 1999, Stroke.

[29]  S. Embretson,et al.  The stroke impact scale version 2.0. Evaluation of reliability, validity, and sensitivity to change. , 1999, Stroke.

[30]  Peg Pashkow,et al.  Physical Rehabilitation Outcome Measures , 1996 .

[31]  Akio Kimura,et al.  Stroke Impairment Assessment Set (SIAS) , 1993 .

[32]  J A Swets,et al.  Measuring the accuracy of diagnostic systems. , 1988, Science.

[33]  Richard W. Bohannon,et al.  Interrater reliability of a modified Ashworth scale of muscle spasticity. , 1987, Physical therapy.

[34]  R. Lyle.  A performance test for assessment of upper limb function in physical rehabilitation treatment and research , 1981, International journal of rehabilitation research. Internationale Zeitschrift fur Rehabilitationsforschung. Revue internationale de recherches de readaptation.

[35]  A. Fugl-Meyer,et al.  The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. , 1975, Scandinavian journal of rehabilitation medicine.

[36]  D. Mozaffarian,et al.  Executive summary: heart disease and stroke statistics--2010 update: a report from the American Heart Association. , 2010, Circulation.

[37]  J. Ware.  SF-36 health survey: Manual and interpretation guide , 2003 .

[38]  Naoichi Chino,et al.  Functional Evaluation of Stroke Patients , 1996, Springer Japan.

[39]  Bernadette M. Marriott,et al.  Evaluation of Physical Performance , 1994 .

[40]  W. Youden,et al.  Index for rating diagnostic tests , 1950, Cancer.