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RecruitingNCT06237972Updated Feb 5, 2024

Effect of a PBT Combined With FES on Reactive Balance Persons With in Stroke

An interventional study of 4-week Perturbation-based balance training and Neuromuscular electrical stimulation in Stroke, sponsored by Pontificia Universidad Catolica de Chile. Recruiting at 1 site in Chile. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-05.

Sponsored by Pontificia Universidad Catolica de Chile · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Registered 4 months after the study started (first participant enrolled Sep 2023, registered Jan 2024).
  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Stroke

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Keywords

  • Reactive Balance
  • Stroke
  • fall risk predictors
  • Perturbation-based balance training
  • Neuromuscular electrical stimulation
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 44 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Pontificia Universidad Catolica de Chile is the lead sponsor of 215 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Healthy participants will be included if they passed a cognitive test (> 26/30 on Montreal Cognitive Assessment Scale) and finish a six-minute walk test independently (to ensure that these individuals can walk without balance or gait impairments)

Exclusion criteria

Exclusion Criteria:

Healthy individuals will be excluded if they self-reported any neurological, musculoskeletal, or other systemic disorders that would affect the participant's locomotion.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    FES group

    This group will conduct the experimental protocol using neuromuscular electrical stimulation during the training.

    Procedure: 4-week Perturbation-based balance training · Device: Neuromuscular electrical stimulation

  • Active comparator
    No-FES group

    This group will conduct the experimental protocol without using neuromuscular electrical stimulation during the training.

    Procedure: 4-week Perturbation-based balance training

Interventions

  • Procedure4-week Perturbation-based balance training

    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. Participants will be secured in a safety harness which will be attached to the overhead arch of the platform. Participants will be asked to go to the experimental study cite 11 times. A baseline screening, 8 training sessions, a post-training screening, and a 2 months folow up screening

    Also known as: PBT

  • DeviceNeuromuscular electrical stimulation

    NMES will be applied on tibialis anterior and quadriceps muscles during perturbation-based balance training.

    Also known as: NMES

06

What researchers measure

Primary outcomes

  1. Step to step transition

    The step-to-step transition phase will be delimited by the time where the CoM reaches its minimal vertical velocity before the contact of the front foot and its maximal vertical velocity after toe off. The time of occurrence of the minimal vertical velocity of the CoM (Vvmin) relative to contact of the frontal foot, expressed in milliseconds, will be calculated.

    Time frame: 12 weeks

  2. Muscular activity patterns

    Muscular activity patterns: We will use four EMG sensors (Trigno Lite System-Delsys) positioned in both rectus femoris (RF) and medial gastrocnemius (MG) according to SENIAM´s indications. The EMG signal will be filtered with a bandpass filter between 20-500 Hz. Then the rectified EMG signal will be used to calculate the on-set detection using the k-means cluster analysis. Three clusters will be assigned to k-means cluster analysis, where the lowest cluster reflects inactivity. Then, EMG bursts will be identified, using the following criteria: every burst shorter than 5 ms will be discarded; bursts separated by \<125 ms will be considered the same burst. In addition, the EMG amplitude will be calculated based on smoothed with a low-pass filter at 10 Hz, and will be normalized based on the maximal amplitude registered in the first "slip-like" perturbation (after familiarization trial).

    Time frame: 12 weeks

Secondary outcomes

  1. Reactive balance

    Perturbation outcomes will be identified as a fall or as a recovery. A fall occurrence will be detected when the force exerted through the safety-harness load cell exceeds 30% of body weight or if the participant requires maximum assistance by the research assistant to maintain the standing position after the perturbation. These outcomes will be verified by video analysis.

    Time frame: 12 weeks

  2. Stability

    It is measured as the shortest distance from the CoM state (position and velocity) to the backward balance loss threshold. The instantaneous CoM state is determined by its position and velocity relative to the base of support (BOS), normalized respectively to the foot length and to the square root of the product of gravitational acceleration (g) and the body height (bh). Reactive stability will be obtained after slip onset during the perturbed trials.

    Time frame: 12 weeks

  3. Transition mode

    The transition mode is defined by the time of occurrence of the Vvmin relative to the beginning of the double contact phase. When Vvmin occurs before contact of the frontal foot, the transition is 'active' while when Vvmin occurs at or after contact of the frontal foot, the transition is 'passive'.

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
  • Pontificia Universidad Catolica de Chile
    Santiago, 7550000, Chile
    Recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06237972
Lead sponsor
Pontificia Universidad Catolica de Chile
Collaborators
Agencia Nacional de Investigación y Desarrollo
Responsible party
Gonzalo Varas (PhD Rehabilitation Sciences. Assistant Professor, Pontificia Universidad Catolica de Chile) — Principal investigator
First posted
Feb 2, 2024
Start date
Sep 1, 2023
Primary completion
Dec 2025 (estimated)
Completion
Apr 2026 (estimated)
Last update
Feb 5, 2024

Study contacts

Gonzalo Varas, PhD
Contact
gonzalo.varas@uc.cl
998957436
Gonzalo Varas, PhD
principal investigator · Pontificia Universidad Catolica de Chile

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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