Soleus Loading Response During Walking

NCT05436366 | Completed

• 2 other identifiers: SU-22-026P2CHD086844
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke survivors experience motor deficits, weak voluntary muscle activations, and low weight-bearing capacity that impair ambulation. Restoring motor function is a priority for people post-stroke, whose gait patterns are slow, and metabolically inefficient. The role of the ankle is crucial for locomotion because it stores mechanical energy throughout the stance phase, leading to a large activation of plantarflexor muscles during push-off for propulsion. After a stroke, paretic plantarflexors undergo changes in their mechanics and activation patterns that yield diminished ankle power, propulsion, and gait speed. Recovery of lost plantarflexor function can increase propulsion and mitigate unnatural gait compensations that occur during hemiparetic walking. In the stance phase, dorsiflexion is imposed at the ankle and the plantarflexors are loaded, which results in excitation of group Ia and II afferents, and group Ib afferents. Load sensing Ib afferents are active in mid-late stance, and through spinal excitatory pathways, reinforces the activation of plantarflexors and propulsive force generation at the ankle. Targeting the excitability of the load sensitive Ib excitatory pathway, propulsive soleus activity and resulting force generation (and thereby gait speed) can be improved after stroke. The long-term research goal is to develop a novel hybrid gait paradigm integrating operant conditioning and powered wearable devices to advance neuro-behavioral training and enhance locomotor ability after stroke. The overall objectives are to 1) modulate the soleus muscle loading response within the stance phase, and 2) develop a dynamic protocol to operantly condition the soleus response in stroke survivors. The central hypothesis is that enhancing the soleus loading response in mid-late stance phase through operant up-conditioning can increase plantarflexor power and forward propulsion after stroke. In working towards attaining the research objective and testing the central hypothesis, the objective of this pilot study is to modulate the soleus loading response in the stance phase during treadmill walking. The specific aims in this study are to 1) apply ankle perturbations in mid-late stance phase combining a control algorithm and a powered device to characterize the changes in soleus EMG between perturbed and unperturbed (i.e., when no perturbations are applied) step cycles in 15 able-bodied individuals; and 2) determine the feasibility of the wearable ankle device and its algorithm in 5 participants with hemiparesis and gait deficits due to a stroke. The testing of the device and its algorithm will provide foundational evidence to adjust the soleus stimuli continuously and reliably, and develop the new walking operant conditioning protocol for stroke survivors. An expected outcome in this pilot is to lay the groundwork to develop the soleus up-conditioning protocol as a potential strategy to improve paretic leg function. If successfully developed, this new protocol proposed in a subsequent study will be the first neurobehavioral training method that targets spinal load-sensitive pathways to improve ankle plantarflexor power and forward propulsion after stroke.

Conditions

Healthy; Spastic Hemiparesis; Stroke

Keywords

Gait; Exoskeleton; EMG

Outcome Measures

Primary Outcomes (1)

• Change in soleus EMG response

  Changes in the soleus EMG response is the primary measure, which is the difference between the non-perturbed and perturbed EMG (i.e., the difference between the EMG obtained during step cycles with and without the applied ankle joint perturbation).

  From enrollment to end of intervention at approximately 1 week

Study Arms (1)

Soleus Loading Response Experimental

EXPERIMENTAL

Participants in this one arm will be administered the soleus loading response protocol by applying an ankle joint rotation during treadmill walking

Device: Soleus loading response in able-bodied participants; Device: Soleus loading response in participants with hemiparesis

Interventions

Soleus loading response in able-bodied participants DEVICE

Able-bodied participants are enrolled. The robotic ankle device applies ankle joint rotations using a computer-controlled closed-loop algorithm to evoke the soleus loading response during the mid-late stance phase during treadmill walking at a self-selected comfortable fast speed. The algorithm applies ankle perturbations, which are shifts from the natural ankle kinematics to target the soleus loading response in mid-late stance phase every other 4-6 gait cycles. The perturbation magnitude, speed, and timing are controlled by the device to adjust the participant's soleus response. Four-to-five walking bouts are conducted interleaving perturbed and unperturbed walking steps (until collecting data of about 30 perturbed and unperturbed steps per walking bout) leaving at least one unperturbed step before a perturbed step. Changes in the soleus EMG will be compared between perturbed and unperturbed walking steps.

Soleus Loading Response Experimental

Soleus loading response in participants with hemiparesis DEVICE

Participants with spastic hemiparesis due to a stroke are enrolled. The robotic ankle device applies ankle joint rotations using a computer-controlled closed-loop algorithm to evoke the soleus loading response during the mid-late stance phase during treadmill walking at a self-selected comfortable fast speed. The algorithm applies ankle perturbations, which are shifts from the natural ankle kinematics to target the soleus loading response in mid-late stance phase every other 4-6 gait cycles. The perturbation magnitude, speed, and timing are controlled by the device to adjust the participant's soleus response. Four-to-five walking bouts are conducted interleaving perturbed and unperturbed walking steps (until collecting data of about 30 perturbed and unperturbed steps per walking bout) leaving at least one unperturbed step before a perturbed step. Changes in the soleus EMG will be compared between perturbed and unperturbed walking steps.

Soleus Loading Response Experimental

Eligibility Criteria

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

Sponsors & Collaborators

• Victor H. Duenas: lead
• Medical University of South Carolina: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Syracuse University

Syracuse, New York, 13244, United States

Location

MeSH Terms

Conditions

Hemiplegia; Stroke

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Victor H Duenas, PhD

  Syracuse University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single arm

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 29, 2022
• Study Start: September 30, 2022
• Primary Completion: July 31, 2024
• Study Completion: August 31, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

US (1)