Soleus loading response in participants with hemiparesis for Stroke

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Syracuse University, Syracuse, NY
Stroke+3 More
Soleus loading response in participants with hemiparesis - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Spastic Hemiplegia
  • Healthy Subjects (HS)
  • Stroke

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Stroke

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: From enrollment to end of intervention at approximately 1 week

Week 1
Change in soleus EMG response

Trial Safety

Safety Progress

1 of 3

Other trials for Stroke

Trial Design

1 Treatment Group

Soleus Loading Response Experimental
1 of 1
Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Soleus loading response in participants with hemiparesis · No Placebo Group · N/A

Soleus Loading Response ExperimentalExperimental Group · 2 Interventions: Soleus loading response in able-bodied participants, Soleus loading response in participants with hemiparesis · Intervention Types: Device, Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from enrollment to end of intervention at approximately 1 week
Closest Location: Syracuse University · Syracuse, NY
2007First Recorded Clinical Trial
2 TrialsResearching Stroke
10 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
For adults, the inclusion criterion is adults with no known neurological conditions or history of orthopedic injuries.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.