Effect of NMES on Balance and Fall Risk in Chronic Stroke

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT04957355
Status
Recruiting
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Conditions

  • Chronic Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Neuromuscular electrical stimulation (NMES) or Functional electrical stimulation (FES) — DEVICE
    Stance and Walk-Perturbation Training Protocol ActiveStep and Surefooted Protocol: Perturbation training protocol with and without FES Participants will be asked to perform a postural disturbance protocol in the stance position and walk in the form of 7 slips and 7 trips with two retention trials after the training using the ActiveStep treadmill system while fitted in a safety harness. All perturbations will be delivered at each participant's comfortable walking speed. Similar slip and trip training in walking will be conducted on the surefooted platform with and without FES. Gait Training Protocol and Surefooted protocol Participants will be asked to perform a 10m walking test (walking for a distance of 45 feet) in a laboratory environment six times (three times with and without FES) and in an outdoor environment located in the parking lot of the Applied Health Science building (1919 W. Taylor St., Chicago, IL)

Study Details

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.

Key Dates

Start date
May 15, 2021
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Effect of functional electrical stimulation on reactive balance and laboratory falls
    All individuals will be assigned to the experimental group and will undergo the testing and training procedure across two separate sessions. During the first session, the participants will go through the complete initial screening process. If eligible for the study, the participants will perform the experimental training protocols during the second session. Experimental Protocol The quadriceps, hamstrings, tibialis anterior, gastrocnemius, and the trunk muscle group on the stroke-affected side (weaker side) will be stimulated according to the participant's comfort and tolerance. The range of the intensity allowed by the device is 0-50milliamperes (mA). The frequency of the electrical stimulation device ranges from 1-60Hz.

Primary Outcome Measure

Laboratory Falls [ Time Frame: Baseline (1st Novel slip/trip, Session 2, Week 1) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois at ChicagoChicagoIllinois60612
Tanvi Bhatt, PhD
[email protected]
3123554443
Rudri Purohit, MS
[email protected]
3128773640

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By research site
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