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

NCT06237972 | Recruiting

• 1 other identifier: 11230645
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  12 weeks

• 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).

  12 weeks

Secondary Outcomes (3)

• Reactive balance

  12 weeks

• Stability

  12 weeks

• Transition mode

  12 weeks

Study Arms (2)

FES group

EXPERIMENTAL

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

No-FES group

ACTIVE COMPARATOR

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

Procedure: 4-week Perturbation-based balance training

Interventions

4-week Perturbation-based balance training PROCEDURE

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

FES group; No-FES group

Neuromuscular electrical stimulation DEVICE

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

Also known as: NMES

FES group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• Agencia Nacional de Investigación y Desarrollo: collaborator

Study Sites (1)

Pontificia Universidad Catolica de Chile

Santiago, 7550000, Chile

RECRUITING

Related Publications (1)

• 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.

  PMID: 40501024 DERIVED

Related Links

• Functional electrical stimulation to enhance reactive balance among people with hemiparetic stroke
• Application of neuromuscular electrical stimulation on the support limb during reactive balance control in persons with stroke: a pilot study

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gonzalo Varas, PhD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gonzalo Varas, PhD

CONTACT

998957436; gonzalo.varas@uc.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Rehabilitation Sciences. Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 2, 2024
• Study Start: September 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)