Chronic Stroke Outcome Measures for Motor Function Intervention Trials

Abstract

Background About half of stroke survivors experience severe and significant long-term disability. The purpose of this paper is to review the state of the science and to make recommendations for measuring patient-centric outcomes in interventions for motor improvement in the chronic stroke phase. Methods and Results A nine-member expert panel reviewed evidence to identify measures of upper and lower extremity function used to-date as outcomes in trials with patients who experienced a stroke 6 or more months prior to assessment. Outcome measures were screened using StrokEDGE consensus panel recommendations, and evaluated for availability of a published minimal clinically important difference (MCID). Measures meeting these criteria were further evaluated with regard to their level of measurement, psychometric properties, and ability of MCID to capture gains associated with improved function and clinical relevance to patients, to arrive at recommendations. A systematic literature review yielded 115 clinical trials of upper and lower extremity function in chronic stroke that used a total of 34 outcome measures. Seven of these had published MCIDs and were recommended or highly recommended by StrokEDGE. Those are 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 the Stroke Impact Scale. All had evidence for the psychometric performance, although the strength of evidence for validity varied, especially in chronic stroke populations Fugl-Meyer Upper and Lower Extremity scales showing the strongest evidence for validity. Conclusions The panel recommends that the Fugl-Meyer Upper and Lower Extremity scales be used as primary outcomes in intervention trials targeting motor function in chronic stroke populations. The other six measures are recommended as secondary outcomes.

Messung von Mobilität und Funktion der unteren Extremität in einem ambulanten neurorehabilitativen Setting

“…Mithilfe der Messinstrumente lassen sich Veränderungen des Funktionsstatus abbilden und erlauben somit eine objektive Aus-sage über das Erreichen der Therapieziele. Allerdings besteht hier noch weiterer Forschungsbedarf, da aktuell noch kein Goldstandard für die Beurteilung der Funktion der unteren Extremität definiert wurde [30].…”

“…Die Stufen haben folgende Bedeutung: 1 = Person kann nicht alleine fahren, benötigt Hilfe von mindesten 2 Personen; 2 = Person benötigt Hilfe von einer Person, die direkt stützt; 3 = Person benötigt eine Begleitperson, die aber nicht direkt stützen muss; 4 = Person kann unabhängig öffentliche Verkehrsmittel benutzen.Bis auf das letzte Instrument zur Erfassung der Benutzung öffentlicher Verkehrsmittel handelt es sich bei allen oben genannten um validierte Testverfahren für Personen mit Schlaganfall. Dabei ist aktuell kein Goldstandard für die Beurteilung der Funktion der unteren Extremität definiert[30].Für die statistischen Analysen diente IBM SPSS Statistics Version 24. Deskriptive Statistiken wurden für die demografischen Baseline-Daten verwendet und dabei Häufigkeiten und Prozente für kategoriale Variablen und Mittelwerte und die dazugehörigen Standardabweichungen für kontinuierliche Variablen errechnet.…”

Translational Stroke Research

“…6 A better tool to measure sensorimotor recovery after stroke is the Fugl-Meyer scale. 7 Validation of more sensitive outcome measures for clinical trials should be a priority.…”

Clinical trial design for stem cell therapies in stroke: What have we learned?

“…Whether the current outcome measures are appropriate for recovery trials is less clear. There may be gains from adoption of more focused scales such as the Fugl-Meyer motor scale, 56 but this inevitably limits recruitment to patients with motor deficits. Restricting recruitment to specific deficits dictated by the outcome measurement chosen will inevitably restrict recruitment (eg only 6% of screened patients were eligible for an upper limb rehabilitation study 57 ).…”