Walking adaptability therapy after stroke: study protocol for a randomized controlled trial

Abstract

Background: Walking 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.

Methods: This 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.

Discussion: This 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 registration: Netherlands Trial Register NTR4030 . Registered on 11 June 2013, amendment filed on 17 June 2016.

Keywords: Exercise; Rehabilitation; Stroke; Therapy; Walking adaptability; Walking speed.

Fig. 1

Snapshots of the two interventions aimed at improving walking speed and walking adaptability: (a) obstacle course of the overground FALLS program; (b) targeted-stepping exercise of treadmill-based C-Mill therapy

Fig. 2

Flow chart of the procedures that participants will undergo

Fig. 3

Exercises of treadmill-based C-Mill therapy: (a) obstacle avoidance; (b) visually guided stepping to a sequence of stepping targets; (c) acceleration and deceleration evoked by a moving walking area; (d) functional and interactive walking adaptability game (adopted from Van Ooijen et al. [20])

Fig. 4

Exercises of the obstacle course of the overground FALLS program: (a) obstacle avoidance; (b) walking over uneven terrain; (c) tandem walking; (d) slalom walking

Fig. 5

Walking adaptability assessment using the 10 Meter Walking Test with context: (a) obstacle avoidance; (b) targeted stepping and; (c) tandem walking

Fig. 6

Walking adaptability assessments using the Interactive Walkway: (a) avoidance of suddenly appearing obstacles and (b) walking to a sequence of stepping targets, both presented on the walking surface in a gait-dependent manner