Effect of NMES on Balance and Fall Risk in Chronic Stroke
ConditionChronic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Illinois at Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Presence of hemiparesis.
Onset of stroke (> 6 months).
Ability to walk independently with or without an assistive device for at least 300 ft.
Can understand and communicate in English.
Disqualifiers
Body weight more than 250 lbs.
Any neurological condition other than stroke.
Any cardiopulmonary, musculoskeletal, or systemic diagnosis.
Recent major surgery (< 6 months) or hospitalization (< 3 months).
Trial design
Design model
Single group
Treatments tested in this trial
Neuromuscular electrical stimulation (NMES) or Functional electrical stimulation (FES)
DeviceStance 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)
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Effect of functional electrical stimulation on reactive balance and laboratory fallsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Laboratory Falls
The outcome of a perturbation trial is dichotomous with #1 being a fall, which is assigned if the force detected by the load-cell exceeded 30% of the participant's body weight after perturbation or if the researcher assists the participant to attain a standing position following perturbation. Otherwise, the outcome is regarded as a non-fall (#0). Laboratory falls are reported in percentage (%), defined as the number of falls experienced during perturbation trials related to the total number of perturbation trials.
Time frame
Baseline (1st Novel slip/trip, Session 2, Week 1)Secondary outcomes
1
Reactive (post-slip) Stability
Post-slip (reactive) stability is calculated from the COM state (position and velocity) and computed at the instance of the first compensatory limb touchdown post-slipping. Values \< 0 indicated a greater possibility of experiencing backward loss of balance and vice versa for values \> 0.
Time frame
Baseline (1st Novel slip/trip, Session 2, Week 1)2
Pre-slip Stability
Pre-slip stability is calculated from the COM state (its position and velocity) and computed at the instance of slipping limb touchdown (before the perturbation onset).
Time frame
Baseline (1st Novel slip/trip, Session 2, Week 1)3
Vertical limb support
Vertical limb support will be quantified by the hip height i.e., the vertical distance between the midpoint of bilateral hips to the floor (Zhip), which is determined from the anterior-superior iliac spine markers and normalized by each participant's body height. The hip height will be assessed at the instance of post-slip compensatory limb touchdown, which indicates the instance of maximal hip descent following perturbation. Higher hip height values indicate greater vertical limb support.
Time frame
Baseline (1st Novel slip/trip, Session 2, Week 1)4
Compensatory step length
The step length will be assessed as the distance from slipping heel to non-slipping heel at the instance of recovery touchdown. A more negative step length indicated a longer backward compensatory step and vice versa.
Time frame
Baseline (Session 2, Week 1)Sponsors and contacts
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Source ClinicalTrials.gov