Acute Neural and Biomechanical Effects of the Tibion Bionic Leg

Not Applicable

Recruiting

• Conditions: post-stroke hemiparesis; Neurological - Other neurological disorders; Stroke - Haemorrhagic

• Registration Number: ACTRN12612000636853
• Lead Sponsor: Tibion Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

stroke (either ischemic or hemorrhagic)-at least one, no more than three,
cortical or sub-cortical distribution,
minimum of 6months post-event,
ability to walk 25' on level using assistive devices and/or orthotics
ability to follow three-step commands
Health individuals, age and gender-matched to stroke participants.

Exclusion Criteria

brainstem or cerebellar stroke
multiple strokes
BoTox injections within 90 days of enrollment
for Study2 - history of and/or risk of seizure, metal implants in head.
Healthy Controls both studies, any history of orthopaedic, neurologic or cardiovascular pathology.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study1a - knee joint power (kinetics) of side wearing the Tibion Bionic Leg - during walking<br><br>Kinetics are measuring using instrumented motion analysis including force plates.[Study1a - Comparison between with and without Tibion Leg];Study1b - Proportion of total Vertical Ground Reaction Force (vGRF) contributed by paretic side during sit-to-stand<br><br>vGRF is measured using force plates in a motion analysis lab.[Study1b - Comparison between with and without Tibion leg];Study2 - Intracortical inhibition (ICI) of the ipsilesional hemisphere<br><br>ICI is measured using transcranial magnetic stimulation (TMS).[Study2 - Comparison during walking with and without Tibion leg]

Secondary Outcome Measures

Name	Time	Method
Study1a - Paretic Limb Single-limb (PSLS) support time<br><br>PSLS is measured using motion analysis.[Study1a - Comparison between with and without Tibion Leg];Study1b - Knee joint power during sit-to-stand<br><br>Joint powers are measured using motion analysis including force plates.[Study1b - Comparison between with and without Tibion leg];Study2 - Paretic Limb Single-limb support time<br><br>PSLS is measured using motion analysis.[Study2 - Comparison during walking with and without Tibion leg]