The efficacy of C-Mill training for improving walking ability, walking speed and gait adaptability in people post stroke: a single-centre RCT

Almost one third of people with stroke remain unable to walk without
supervision in their communities. For most people with stroke, regaining the
ability to walk in their communities is of high importance. Community walking,
however, requires the ability to adjust gait relative to the environment in
order to avoid obstacles for example. Since the ability to adjust gait is often
impaired after stroke, improving gait adaptability after stroke might improve
safe community walking. The C-Mill, a treadmill that allows for projecting
visual obstacles and targets on the belts* surface, has recently shown positive
effects in that regard.

The main objective of the proposed study is to examine the relative efficacy of
C-Mill gait adaptability treadmill training compared to the Nijmegen Falls
Prevention Program (NFP program) for improving walking ability aspects,
particularly walking speed (10m timed walking test [10MWT]) and gait
adaptability using an Interactive Walkway (IWW), in persons with stroke.
Secondary objective is to assess the efficacy of the two forms of training on
other commonly used gait and balance related clinimetric measures (e.g.
Functional Ambulation Categories [FAC], Timed Up-and-Go [TUG] test, Berg
Balance Scale [BBS]) as well as on fear of falling (Activities-specific Balance
Confidence [ABC] scale).

This study is a single-centre randomized controlled trial with pre-tests,
post-tests, retention tests and a 12 month follow-up.

Participants will be allocated to either 5 weeks of C-Mill training, which is
treadmill training with a specific emphasis on training gait adaptability, or 5
weeks of the NFP program. Both interventions are provided twice per week and
are matched in terms of frequency, duration and therapist-attention.
Randomization will be optimized for age, time post stroke and FAC score.

In order to improve safe community ambulation after stroke, it is important to
gather evidence on the efficacy and underlying design features of intervention
programs aimed at improving walking ability, walking speed and gait
adaptability. The proposed study therefore aims to examine the relative
efficacy of C-Mill gait adaptability training (high intensity, gait
adaptability training) compared to the NFP program (lower intensity, gait
adaptability training) on walking in persons with stroke. The present study
will thus unveil the relative importance of practice intensity as a key design
feature for effective intervention programs directed at improving gait
adaptability and gait speed as important aspects of community walking after
stroke. The risks of participating in the current study are negligible. The
intensity of the training is only increased as tolerated by the participant.
Persons that participate in this study are reasonably good community walkers.
In addition, C-Mill training and the NFP program are frequently used methods in
rehabilitation, and both are provided as regular therapy in Reade. The only
burden of participating in the current study is the time investment associated
with the training program, the pre-test, post-test, retention test. and
follow-up test. The test will each take approximately 90-120 minutes and
training will be provided twice per week for 90 minutes.