Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06237972
Status:
RECRUITING
Last Update Posted:
2024-02-05
First Post:
2024-01-15
Brief Title:
Effect of a PBT Combined With FES on Reactive Balance Persons With in Stroke
Sponsor:
Pontificia Universidad Catolica de Chile
Organization:
Pontificia Universidad Catolica de Chile
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 andor 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 11 to the NMES n20 or No-NMES group N20 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 046 ms with an acceleration of 94 ms2 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
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 11 to the NMES n20 or No-NMES group N20 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 046 ms with an acceleration of 94 ms2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None