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).

KEYWORDS:

• Stroke
• rehabilitation
• upper extremity
• minimal clinically important difference
• robotics

Disclosure statement

Dr. Uchiyama reports nonfinancial support from Teijin Pharma and Tsukuba Clinical Research and Development Organization, University of Tsukuba, during the conduct of the study. Dr. Takebayashi reports personal fees from Teijin Pharma and nonfinancial support from Tsukuba Clinical Research and Development Organization, University of Tsukuba, during the conduct of the study. K. Takahashi reports personal fees from Teijin Pharma and nonfinancial support from Tsukuba Clinical Research and Development Organization, University of Tsukuba, during the conduct of the study. Dr. Amano reports nonfinancial support from Tsukuba Clinical Research and Development Organization, University of Tsukuba, during the conduct of the study. M. Sakai reports nonfinancial support from Teijin Pharma during the conduct of the study. Dr. Hashimoto reports nonfinancial support from Teijin Pharma during the conduct of the study. Dr. Hachisuka reports nonfinancial support from Teijin Pharma and Tsukuba Clinical Research and Development Organization, University of Tsukuba, during the conduct of the study. The other authors report no conflicts.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/10749357.2023.2259649

Additional information

Funding

This work was funded by Teijin Pharma Limited.