Operant Conditioning of Reflex Pathways to Improve Walking in Individuals Post-stroke
1 other identifier
interventional
5
1 country
1
Brief Summary
The purpose of this study is to examine the changes in reflex pathways in the paretic ankle plantarflexors in individuals with post-stroke hemiparesis using operant conditioning. We are recruiting 5 individuals with chronic post-stroke hemiparesis with foot drop in the affected leg to participate in the reflex training procedure. The study involves 40 visits with a total study duration of about 4 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Aug 2022
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2022
CompletedFirst Submitted
Initial submission to the registry
March 24, 2023
CompletedFirst Posted
Study publicly available on registry
April 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedApril 6, 2023
March 1, 2023
3.4 years
March 24, 2023
March 24, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in magnitude of reciprocal inhibition
Before training Baseline, after completion of 30 training sessions, and 1 month after the completion of intervention
Study Arms (1)
Reciprocal inhibition up conditioning
EXPERIMENTALEach participant completes 6 baseline sessions and 30 up conditioning sessions. In the 30 conditioning sessions, the magnitude of reciprocal inhibition in the paretic leg of participants post-stroke will be up conditioned.
Interventions
In this training, individuals with post-stroke hemiparesis are trained to increase the amount of reciprocal inhibition in their paretic leg. By increasing the amount of reciprocal inhibition, the paretic ankle in people post-stroke may exhibit less foot drop.
Eligibility Criteria
You may qualify if:
- At least 6 months following a single, unilateral stroke, resulting in hemiparesis.
- Ambulatory with or without assistive device, but must demonstrate a gait deficit which is indicative of foot drop from reduced activation of the tibialis anterior muscle.
- Able to follow verbal directions.
- Able to see icons on computer monitor (with or without corrective lenses) from at least 4 feet away.
- All subjects will be adults at least 18 years old.
- Know history and current medication management for lower limb spasticity, if any.
You may not qualify if:
- No history of ear disease or balance problems outside of those caused by the stroke.
- Cerebellar stroke
- No other neurological disease or injuries other than the stroke affecting the use of the legs and/or walking.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Nevada, Las Vegas
Las Vegas, Nevada, 89154, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2023
First Posted
April 6, 2023
Study Start
August 1, 2022
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
April 6, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share