Functional gait rehabilitation in elderly people following a fall-related hip fracture using a treadmill with visual context: design of a randomized controlled trial

Abstract

BackgroundWalking requires gait adjustments in order to walk safely in continually changing environments. Gait adaptability is reduced in older adults, and (near) falls, fall-related hip fractures and fear of falling are common in this population. Most falls occur due to inaccurate foot placement relative to environmental hazards, such as obstacles. The C-Mill is an innovative, instrumented treadmill on which visual context (e.g., obstacles) is projected. The C-Mill is well suited to train foot positioning relative to environmental properties while concurrently utilizing the high-intensity practice benefits associated with conventional treadmill training. The present protocol was designed to examine the efficacy of C-Mill gait adaptability treadmill training for improving walking ability and reducing fall incidence and fear of falling relative to conventional treadmill training and usual care. We hypothesize that C-Mill gait adaptability treadmill training and conventional treadmill training result in better walking ability than usual care due to the enhanced training intensity, with superior effects for C-Mill gait adaptability treadmill training on gait adaptability aspects of walking given the concurrent focus on practicing step adjustments.Methods/designThe protocol describes a parallel group, single-blind, superiority randomized controlled trial with pre-tests, post-tests, retention-tests and follow-up. Hundred-twenty-six older adults with a recent fall-related hip fracture will be recruited from inpatient rehabilitation care and allocated to six weeks of C-Mill gait adaptability treadmill training (high-intensity, adaptive stepping), conventional treadmill training (high-intensity, repetitive stepping) or usual care physical therapy using block randomization, with allocation concealment by opaque sequentially numbered envelopes. Only data collectors are blind to group allocation. Study parameters related to walking ability will be assessed as primary outcome pre-training, post-training, after 4 weeks retention and 12 months follow-up. Secondary study parameters are measures related to fall incidence, fear of falling and general health.DiscussionThe study will shed light on the relative importance of adaptive versus repetitive stepping and practice intensity for effective intervention programs directed at improving walking ability and reducing fall risk and fear of falling in older adults with a recent fall-related hip fracture, which may help reduce future fall-related health-care costs.Trial registrationThe Netherlands Trial Register (http://NTR3222).

The efficacy of treadmill training with and without projected visual context for improving walking ability and reducing fall incidence and fear of falling in older adults with fall-related hip fracture: a randomized controlled trial

“…However, post-intervention assessments (T1) and follow-up assessments at four weeks (T2) and 12 months (T3) after the intervention period were conducted by an independent assessor, who was blinded to group allocation. Falls were monitored monthly between T1 and T3 [19]. …”

“…Using a between-group mean difference of 3.5 POMA points, a standard deviation of 4.8 POMA points and a correlation coefficient of 0.7, sample size calculations revealed that 126 participants were required to achieve a statistical power of 80% with a two-tailed conservative alpha of 0.017 corrected for multiple comparisons and an expected drop-out rate of 24% [19]. …”

“…The present study compared the efficacy of adaptability treadmill training, conventional treadmill training and usual physical therapy on walking ability, fear of falling and fall incidence in older adults after a fall-related hip fracture, with the aim to establish the usefulness of treadmill walking with and without walking adaptability exercises in fall prevention programs [19]. We expected better outcomes related to general walking ability after adaptability and conventional treadmill training than after usual physical therapy due to the greater amounts of walking practice.…”

Tracking gaze while walking on a treadmill: Spatial accuracy and limits of use of a stationary remote eye-tracker

“…Recently, gait rehabilitation programs, based on the combined use of virtual reality and treadmill, aimed at enhancing gait [14]- [17] and at reducing fall risk [16], [18]- [20] in pathological populations. These studies required the participants to negotiate virtual obstacles [14], [15], [17], [18], [20] and the evaluation focused more on the motor performance than the visual strategy. Since an accurate foot placement requires both intact visual and motor abilities [21], virtual environments, including obstacles, may be used to investigate the relationship between the point of gaze and stepping accuracy.…”

“…Specifically, unsatisfactory visual sampling strategies have been observed in elderly fallers when asked to step into a target [5], [13]. Recently, gait rehabilitation programs, based on the combined use of virtual reality and treadmill, aimed at enhancing gait [14]- [17] and at reducing fall risk [16], [18]- [20] in pathological populations. These studies required the participants to negotiate virtual obstacles [14], [15], [17], [18], [20] and the evaluation focused more on the motor performance than the visual strategy.…”