Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06237972 |
| Other study ID # |
11230645 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2023 |
| Est. completion date |
April 2026 |
Study information
| Verified date |
February 2024 |
| Source |
Pontificia Universidad Catolica de Chile |
| Contact |
Gonzalo Varas, PhD |
| Phone |
998957436 |
| Email |
gonzalo.varas[@]uc.cl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial is to evaluate the effect of a 4-week perturbation-based
balance training with and without targeted Neuromuscular electrical stimulation on
neuromechanic gait fall risk predictor and reactive balance.
The aim of this study is to investigate whether a 4-weeks perturbation-based balance training
can improve kinematic and spatiotemporal parameters of reactive balance control, and
kinematic and neuromuscular gait parameters, described as early fall risk predictors, in
persons with stroke. Additionally, a second aim is to determine whether an
impairment-oriented intervention aimed to correct the gait patterns during the proposed
walking perturbation training, using a targeted neuromuscular electrical stimulation (NMES)
applied to the rectus femoris and tibialis anterior muscles, could enhance the potential
benefits of the proposed training protocol among stroke population.
Description:
Background. Although falls are multi-factorial, muscle weakness, gait deficits and impaired
compensatory stepping responses are key contributing factors for falls in persons with
stroke. From a control mechanism perspective, it is postulated that stepping strategies may
be represented by the muscle activity pattern triggered via long-loop brain stem responses
with cortical modulation. However, due to the sensorimotor impairments, commonly observed in
stroke population, components of muscle responses (early and late) are delayed and smaller in
amplitude, which affect the motor responses to unexpected balance disturbances.
Perturbation-based balance training is a novel therapeutic strategy that incorporates
exposure to repeated support surface disturbances simulating environmental perturbations like
slips and trips to evoke rapid reactive balance reactions. Additionally, it has been
described that reactive balance control and sensorimotor adaptation are dependent on severity
of motor impairment. Thus, development of therapeutic interventions aiming to reduce training
times and/or facilitate the inclusion of persons with moderate to severe sensorimotor
impairments are crucial for the implementation of reactive balance training protocols into
clinical practice.
In the present proposal, the investigators aim to investigate whether a 4-weeks
perturbation-based balance training can improve kinematic and spatiotemporal parameters of
reactive balance control, and kinematic and neuromuscular gait parameters, described as early
fall risk predictors, in persons with stroke. Additionally, the investigators aim to
determine whether an impairment-oriented intervention aimed to correct the gait patterns
during the proposed walking perturbation training, using a targeted neuromuscular electrical
stimulation (NMES) applied to the rectus femoris and tibialis anterior muscles, could enhance
the potential benefits of the proposed training protocol among stroke population.
Methods. The study employs a primary two-arm randomized, controlled design to examine effects
of a 4-weeks perturbation-based balance training with and without targeted NMES on reactive
balance control and early gait fall risk predictors in stroke population. Forty participants
will be randomly assigned (1:1) to the NMES (n=20) or No-NMES group (N=20). Participants will
be asked to walk over a six by two meters computer-controlled movable platform at a
self-selected speed. Slip-like perturbations will be induced by the device software that
moves the platform 12 inches forward at 0.46 m/s with an acceleration of 9.4 m/s2. For each
training session, participants will be asked to walk over the computer-controlled movable
platform for six blocks of ten walking trials, among which there will be four perturbation
trials per block. In total, all the participants will experience 24 perturbation trials per
training session. Participants will be asked to come to the Laboratory two times per week, so
each participant will complete 8 perturbation-based balance training sessions.
The following outcome measures will be assessed in the present research proposal:
Perturbation outcomes (fall or recovery), Center of mass (CoM) stability, and limb support of
the slipping (paretic) leg. All these outcomes measures will be assessed after an
externally-induced balance perturbation before and after the 4-weeks perturbation-based
balance training. On the other hand, step-to-step transition and altered neuromusuclar
patterns, both described as early fall risk predictor and assessed through force platform and
electromyography (EMG) respectively, will be assessed during a 5 minutes treadmill walking
test at a self-selected speed before and after the training.
Expected result. The investigators expect that once the proposed training protocol is
finished, participants will show less laboratory falls, and higher CoM stability and limb
support values after experience a gait "slip-like" disturbance compared to a baseline
assessment. Similarly, participants will show improved values in step-to-step transition
(active mode transition) and less deviations from normal values of lower limb EMG patterns,
compared to a baseline evaluation. Regarding the second aim, the investigators expect that
once the proposed training protocol is finished, the group of persons with stroke that will
perform the perturbation-based balance training with the gait pattern corrected (NMES group)
will show less laboratory falls, and higher CoM stability and limb support values after
experience a gait "slip-like" disturbance, and improved values in step-to-step transition
(active mode transition) with less deviations from healthy participants´ lower limb EMG
patterns, during an instrumented gait assessment, compared to the No NMES group.
The investigators believe that the description of changes on kinematic, spatiotemporal and
neuromuscular parameters after a reactive balance training protocol could contribute to a
better understanding of the mechanisms behind compensatory strategies aimed to regain
postural control in persons with stroke. Furthermore, the investigators believe that the
results of this project may be useful in developing new and effective therapeutic strategies
to reduce falls among stroke population and may contribute to facilitate the translation of
perturbation-based balance training into clinical practice.
