AzTrials
AzTrials

StrokeNCT06237972

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

A study testing 4-week Perturbation-based balance training and Neuromuscular electrical stimulation in people with Stroke, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Stroke
What is being tested?
4-week Perturbation-based balance training and Neuromuscular electrical stimulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteChile
Study dates
1 Sep 2023to Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Gonzalo Varas, PhD contact

998957436

gonzalo.varas@uc.cl

Chile1 site, 1 recruiting
  • Pontificia Universidad Catolica de Chile

    Santiago, 7550000

    Mesa central, (56)95504 4000, eticadeinvestigacion@uc.cl

    Recruiting

Other trials in Chile

About this study

Official title: Effect of a Perturbation-based Balance Training Combined With Targeted Neuromuscular Electrical Stimulation on Reactive Balance Control and Early Fall Risk Predictors in Persons With Stroke.

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.

Conditions
Stroke
Being tested
4-week Perturbation-based balance training, Neuromuscular electrical stimulation
Keywords
Reactive Balance, Stroke, fall risk predictors, Perturbation-based balance training, Neuromuscular electrical stimulation
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 4-week Perturbation-based balance trainingProcedure or surgery

    Also called PBT

    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

  • Neuromuscular electrical stimulationDevice

    Also called NMES

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

Study groups in NCT06237972
Study groupRoleWhat they receive
FES groupExperimentalThis group will conduct the experimental protocol using neuromuscular electrical stimulation during the training.
Receives: Procedure: 4-week Perturbation-based balance training; Device: Neuromuscular electrical stimulation
No-FES groupActive comparatorThis group will conduct the experimental protocol without using neuromuscular electrical stimulation during the training.
Receives: Procedure: 4-week Perturbation-based balance training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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).

    Measured: 12 weeks

Secondary outcomes (3)
  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.

    Measured: 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.

    Measured: 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'.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2024
  2. Study start1 Sep 2023
  3. Primary completionDec 2025 (estimated)
  4. Study completionApr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
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 assigned using blocked randomization to one of the two groups. The random allocation sequence will be computer generated. Additionally, a third group of age-matched healthy participants (n=20) will conduct the baseline 5-minutes walking test to collect baseline lower limb EMG patterns that will be used for the Altered muscle activation patterns (AMAP) analysis.
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06237972
Sponsor's protocol ID
11230645
Status last verified
Feb 2024
First submitted
15 Jan 2024
Last updated
5 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Covarrubias-Escudero F, Moenne-Loccoz C, Bhatt T, Nunez-Saavedra G, Orellana-Abarca G, Varas Diaz G. Effects of perturbation-based gait training with and without functional electrical stimulation on reactive balance and neuromuscular coordination after stroke: a randomized controlled trial. Top Stroke Rehabil. 2026 Apr 23:1-16. doi: 10.1080/10749357.2026.2664217. Online ahead of print.

    PubMed 42023814
  • Covarrubias-Escudero F, Appelgren-Gonzalez JP, Nunez-Saavedra G, Urrea-Baeza D, Varas-Diaz G. Enhancing Gait Biomechanics in Persons With Stroke: The Role of Functional Electrical Stimulation on Step-To-Step Transition. Physiother Res Int. 2025 Jul;30(3):e70080. doi: 10.1002/pri.70080.

    PubMed 40501024

Questions about this trial

What is this clinical trial studying?

A study testing 4-week Perturbation-based balance training and Neuromuscular electrical stimulation in people with Stroke, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gonzalo Varas, PhD (998957436, gonzalo.varas@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Step to step transition (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06237972, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in