RecruitingACTRN12612000636853

Acute Neural and Biomechanical Effects of the Tibion Bionic Leg

Acute Neural and Biomechanical Effects of the Tibion Bionic Leg in Persons Post-stroke

Sponsor

Tibion Corporation

Enrollment

45 participants

Start Date

Mar 15, 2012

Study Type

Interventional

Conditions

post-stroke hemiparesis

Summary

The goal of this project is to understand the immediate neural and mechanical effects of the Tibion PK-100 brace on walking function and sit-to-stand of persons post-stroke. Given our current working knowledge of the PK-100 Bionic Leg, we hypothesize that the actuation afforded by the PK-100 will enable improved biomechanical alignment and inter-segmental coordination to reveal: a) increased knee extension in stance phase and b) increased hip extension in mid-late stance that will be maintained into pre-swing. Together, these critical biomechanical components will enable c) unlocking of the knee at the stance-to-swing transition producing: i) increased knee flexion in pre-swing and early swing, ii) improved ankle plantar flexion at terminal stance and iii) improved limb momentum during the stance—to-swing transition. The enhanced stability and improved inter-segmental biomechanical alignment afforded by the PK-100 will facilitate enhanced neuromuscular activation of the paretic limb as evidenced by: a) increased magnitude of muscle activations, b) altered timing of muscle activation patterns towards normal and c) shift in joint powers towards normal. Study1 will address biomechanical parameters including motion patterns, kinetics and muscle activation patterns. Study2 will address parameters of neural control including: cortical excitability and intra-cortical inhibition of the ipsilesional hemisphere during walking with and without the Tibion Bionic Leg.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 95 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a special leg brace called the Tibion Bionic Leg to see how it helps people walk and stand up after a stroke. The brace gives support to the knee and helps the leg move more naturally. Researchers want to measure how the brace changes muscle activity and movement patterns in stroke survivors. You may be eligible if: - You are 18 to 95 years old - You have had one stroke (either a blood clot or a bleed in the brain) - The stroke affected the brain, not the brainstem or cerebellum - At least 6 months have passed since your stroke - You can walk 25 feet with a cane, walker, or brace - You can follow a 3-step instruction You may NOT be eligible if: - You had a stroke in the brainstem or cerebellum - You have had more than one stroke - You have received Botox injections in the last 90 days - You have a history of seizures or metal implants in your head (for the brain scan part of the study) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The goal of this study is to quantify the acute effects of the Tibion Bionic leg, a wearable exoskeleton robot that provides actuated limb assistance. We will study: a) neuromechanical parameters of walking and transfers and b) acute/immediate neural adaptations to during dynamic walking. In Study1, participants will be observed walking and transferring (i.e., sit-to-stand) in their usual manner and walking and transferring while wearing the Tibion Bionic leg. Persons with hemiparesis post-stroke will wear the Bionic Leg on their more affected side. Healthy, age-matched control participants will wear the Bionic leg on a randomly chosen side. Three-dimensional motion analysis, including kinetics and EMG, will obtained to quantify the neuromechanical effects of actuated limb assistance. Activities in Study1 will involve approximately 8 hours of participation distributed over two sessions (days). In Study2, both participants post-stroke and healthy controls will be studied during walking on an instrumented treadmill with and without the Tibion Bionic leg. Transcranial magnetic stimulation (TMS) will be delivered during walking to probe cortical excitability and modulation of intra-cortical inhibition during walking. TMS will be used as a probe (rather than an intervention) to assess adaptations in neuromotor control while walking with the Tibion Bionic Leg. Activities in Study2 will involve approximately 4hours of participation in one session. Single-pulse TMS will be delivered to the motor cortex at sub-threshold intensity during walking. Stimulations will be delivered at a specific point in the gait cycle (i.e., initial contact) once per step for 30-50 steps. Paired-pulse TMS (sub-threshold stimulation followed by supra threshold stimulation at inter-stimulus intervals of 1-6ms) will be delivered to the same region of motor cortex during walking. Participants in Study1 who meet inclusion criteria will be invited to participate in Study2. Enrollment in Study2 will be approximately 90days following Study1.

Locations(1)

FL, United States of America

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