Abstract
BackgroundWalking in everyday life requires the ability to adapt walking to the environment. This adaptability is often impaired after stroke, and this might contribute to the increased fall risk after stroke. To improve safe community ambulation, walking adaptability training might be beneficial after stroke. This study is designed to compare the effects of two interventions for improving walking speed and walking adaptability: treadmill-based C-Mill therapy (therapy with augmented reality) and the overground FALLS program (a conventional therapy program). We hypothesize that C-Mill therapy will result in better outcomes than the FALLS program, owing to its expected greater amount of walking practice.MethodsThis is a single-center parallel group randomized controlled trial with pre-intervention, post-intervention, retention, and follow-up tests. Forty persons after stroke (≥3 months) with deficits in walking or balance will be included. Participants will be randomly allocated to either C-Mill therapy or the overground FALLS program for 5 weeks. Both interventions will incorporate practice of walking adaptability and will be matched in terms of frequency, duration, and therapist attention. Walking speed, as determined by the 10 Meter Walking Test, will be the primary outcome measure. Secondary outcome measures will pertain to walking adaptability (10 Meter Walking Test with context or cognitive dual-task and Interactive Walkway assessments). Furthermore, commonly used clinical measures to determine walking ability (Timed Up-and-Go test), walking independence (Functional Ambulation Category), balance (Berg Balance Scale), and balance confidence (Activities-specific Balance Confidence scale) will be used, as well as a complementary set of walking-related assessments. The amount of walking practice (the number of steps taken per session) will be registered using the treadmill’s inbuilt step counter (C-Mill therapy) and video recordings (FALLS program). This process measure will be compared between the two interventions.DiscussionThis study will assess the effects of treadmill-based C-Mill therapy compared with the overground FALLS program and thereby the relative importance of the amount of walking practice as a key aspect of effective intervention programs directed at improving walking speed and walking adaptability after stroke.Trial registrationNetherlands Trial Register NTR4030. Registered on 11 June 2013, amendment filed on 17 June 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1527-6) contains supplementary material, which is available to authorized users.
Highlights
Walking in everyday life requires the ability to adapt walking to the environment
C-Mill therapy is a patient-tailored type of training in that the therapist can adjust the difficulty of the different exercises by manipulating content parameters as the obstacle size and available response time for obstacle negotiation, the variation in the sequence of stepping targets, and the degree of acceleration and deceleration of the moving walking area
Missing data will be imputed using the data from the last available measurement. This randomized controlled trial will evaluate the relative effects of treadmill-based C-Mill therapy and the overground FALLS program on walking speed and walking adaptability in people with stroke. Both CMill therapy and the FALLS program incorporate practice of walking adaptability and thereby aim at improving community ambulation, and first results are encouraging in this regard [9, 14, 15], it is hypothesized that C-Mill therapy will result in better outcomes than the FALLS program, as a result of the expected greater amount of walking practice owing to treadmill training [18, 20,21,22]
Summary
Participants In total, 40 persons who had a stroke will be recruited from the inpatient and outpatient population of rehabilitation center Reade (Amsterdam, The Netherlands) to participate in this study. Following design considerations for this study (as detailed ), the FALLS program will be performed in groups of four to six persons with two or three therapists per group, with sessions lasting 1.5 hours, including rest Both interventions are matched for therapy duration (90 min), frequency (twice weekly) and therapist. The number of steps taken per therapy session will be recorded, since we expect that the amount of walking practice per session (defined as the number of steps performed during therapy sessions) will be higher for treadmill-based C-Mill therapy than for the overground FALLS program This expectation will be tested by comparing this process measure between the two intervention groups. Missing data will be imputed using the data from the last available measurement
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