Clinical trial NCT04957355: Effect of NMES on Balance and Fall Risk in Chronic Stroke
Official title: Effect of Neuromuscular Electrical Stimulation (NMES) on Reactive Balance, Gait and Fall-risk in Individuals with Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Stroke
Keywords: functional electrical stimulation
neuromuscular electrical stimulation
walk-training
treadmill training
reactive balance
perturbation
falls
fall prevention
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group design to compare the effects of neuromuscular electrical stimulation on reactive balance control, gait, and fall risk in individuals with chronic stroke
Primary purpose: TREATMENT

Brief summary: The aim of this study is to describe the effect of neuromuscular electrical stimulation (NMES) in the form of functional electrical stimulation (FES) applied to different lower limb muscles on reactive balance and gait performance in stroke participants.

Methods: Twenty individuals with chronic stroke will be asked to perform an experimental protocol that includes a postural disturbance in the form of a slip- or trip-like perturbation and a standardized walking test in both laboratory and outdoor environments with and without FES applied to different lower limb muscles of the paretic leg. FES will be applied using an advanced software that is able to synchronize muscle activation with the time of perturbation onset and according to the phases of gait.

This project design aims to examine whether a specific pattern of lower limb muscle stimulation could improve the kinematic and behavioral responses during reactive balance following slip- and trip-like perturbations. Additionally, the project aims to see if the kinematic and spatio-temporal gait parameters can be modified during a standardized walking test under different sensory and environmental conditions.

Detailed description: Functional impairment after a stroke often includes slowed gait velocity and increased fall risk attributed to foot drop (the inability to dorsiflex the ankle during the swing phase of gait) and lower limb muscle weakness. Damage in the motor cortex or corticospinal tract often results in significant, persistent distal muscle weakness, including the sensorimotor control of the ankle joint, typically because of a combination of weakness of the agonist ankle dorsiflexor muscles and spasticity of the antagonist plantar flexor muscle. This results in slower and abnormal gait which leads to gait compensation strategies such as hip hitching, excess circumduction during gait, reduced foot clearance, and high energy expenditure, all of which are factors which could increase the risk of falls in individuals with stroke.

Functional electrical stimulation (FES) corresponds to the application of an electric field across the motor neurons of a muscle to induce an artificial, involuntary contraction to perform a functional movement. Numerous benefits of FES have been reported throughout literature such as increased muscle mass, increased bone mineral density, and improved cardiovascular parameters, among others. Previous studies in which authors assessed the effect of FES on individuals with stroke have demonstrated that the common peroneal nerve stimulates the tibialis anterior muscle to produce foot dorsiflexion during the swing phase of the gait cycle and reduces foot drop by facilitating increased voluntary muscle activity, which together improves the quality and symmetry of gait. Additionally, others studies showed that FES improves walking speed and energy expenditure in individuals with stroke.

In the last years, FES systems have been used as neuroprosthetic devices in rehabilitative interventions such as gait training. Stimulator triggers, implemented to control stimulation delivery, range from open- to closed-loop controllers.12 Finite-state controllers trigger stimulators when specific conditions are met and utilize preset sequences of stimulation. Thus, wearable sensors provide the necessary input to differentiate gait phases during walking and trigger stimulation to specific muscles.13 This technology has been largely used to improve gait parameters in stroke participants, however, it has not been well described how this technology could help stroke participants during the loss of balance or during reactive balance.

On the other hand, the literature suggests that a direct transcortical loop does not trigger the initial phase of postural responses to external perturbations, but it seems likely that the cerebral cortex becomes involved in the later phases of the reactive response.14 Thus, given that postural response lasts for many hundreds of milliseconds, it may be that the brainstem or spinal cord circuits initiate a response, and then the response subsequently becomes modified by cortical circuits during its later phases.15 In this context, the effect of peripheral stimulation to the muscles involved in the reactive response to an unexpected external perturbation on recovery performance has not yet been described.

This project aims to describe whether a specific pattern of lower limb muscle stimulation could modify the recovery response after an unexpected perturbation in the form of a slip and/or trip in individuals with stroke. Also, this project aims to examine if a specific pattern of lower limb muscle stimulation provided by FES can modify kinematic and spatio-temporal gait parameters during a standardized walking test under different sensory conditions.

Eligibility criteria: Inclusion Criteria:

Age group: 18-90 years.

1. Presence of hemiparesis.
2. Onset of stroke (\> 6 months).
3. Ability to walk independently with or without an assistive device for at least 300 ft.
4. Can understand and communicate in English.
5. Cognitively and behaviorally capable of complying with the regimen (Montreal Cognitive Assessment \> 25/30).

Exclusion Criteria:

Subjects will not proceed with the test if any of the following occurs at baseline measurement: 1) HR \> 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age), 2) systolic blood pressure (SBP) \> 165 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during rest, or 3) oxygen saturation (measured by pulse oximeter) \< 95% during rest.

1. Body weight more than 250 lbs.
2. Any neurological condition other than stroke.
3. Any cardiopulmonary, musculoskeletal, or systemic diagnosis.
4. Recent major surgery (\< 6 months) or hospitalization (\< 3 months).
5. Deep venous thrombosis.
6. Antecedent of cancer.
7. Peripheral nerve injury or neuropathy in the affected limb with motor disability.
8. Spasticity (Ashworth scale \> 2).
9. Uncontrolled high blood pressure/angina.
10. Skin condition not tolerant with FES therapy.
11. Uncontrolled seizure disorder.
12. Botox treatment within the last 5 months.
13. History of epilepsy.
14. Pacemaker users.

Excluded or Vulnerable Populations Non-English speaking populations will be excluded as the consent procedures and instructions will be in English.

Primary outcomes:
measure: Laboratory Falls
timeFrame: Baseline (1st Novel slip/trip, Session 2, Week 1)
Secondary outcomes:
measure: Reactive (post-slip) Stability
timeFrame: Baseline (1st Novel slip/trip, Session 2, Week 1)
measure: Pre-slip Stability
timeFrame: Baseline (1st Novel slip/trip, Session 2, Week 1)
measure: Vertical limb support
timeFrame: Baseline (1st Novel slip/trip, Session 2, Week 1)
measure: Compensatory step length
timeFrame: Baseline (Session 2, Week 1)
measure: Compensatory step initiation time
timeFrame: Baseline (Session 2, Week 1)
measure: Compensatory step execution time
timeFrame: Baseline (Session 2, Week 1)
measure: Number of compensatory steps
timeFrame: Baseline (Session 2, Week 1)
measure: Medio-Lateral excursion of center of mass
timeFrame: Baseline (1st Novel slip/trip, Session 2, Week 1)
measure: Center of mass excursion angle
timeFrame: Baseline (1st Novel slip/trip, Session 2, Week 1)
measure: Gait speed
timeFrame: Baseline (Session 2, Week 1)
measure: Walking cadence
timeFrame: Baseline (Session 2, Week 1)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Tanvi Bhatt, PhD
role: PRINCIPAL_INVESTIGATOR
References: