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Trial registered on ANZCTR


Registration number
ACTRN12612000636853
Ethics application status
Approved
Date submitted
1/06/2012
Date registered
14/06/2012
Date last updated
15/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acute Neural and Biomechanical Effects of the Tibion Bionic Leg
Scientific title
Acute Neural and Biomechanical Effects of the Tibion Bionic Leg in Persons Post-stroke
Secondary ID [1] 280248 0
Nil
Universal Trial Number (UTN)
Trial acronym
n/a
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-stroke hemiparesis 286202 0
Condition category
Condition code
Neurological 286412 286412 0 0
Other neurological disorders
Stroke 286876 286876 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 284592 0
Treatment: Devices
Intervention code [2] 284593 0
Rehabilitation
Comparator / control treatment
In Study1 neuromechanical function in persons post-stroke will be compared between performance with and without the Tibion Bionic Leg. Comparisons will also be made to age and gender matched control participants walking and performing sit-to-stand with and without the Tibion Bionic Leg.

In Study2, within subject comparisons will be made between with and without Tibion Bionic Leg conditions.
Control group
Active

Outcomes
Primary outcome [1] 286858 0
Study1a - knee joint power (kinetics) of side wearing the Tibion Bionic Leg - during walking

Kinetics are measuring using instrumented motion analysis including force plates.
Timepoint [1] 286858 0
Study1a - Comparison between with and without Tibion Leg
Primary outcome [2] 287246 0
Study1b - Proportion of total Vertical Ground Reaction Force (vGRF) contributed by paretic side during sit-to-stand

vGRF is measured using force plates in a motion analysis lab.
Timepoint [2] 287246 0
Study1b - Comparison between with and without Tibion leg
Primary outcome [3] 287247 0
Study2 - Intracortical inhibition (ICI) of the ipsilesional hemisphere

ICI is measured using transcranial magnetic stimulation (TMS).
Timepoint [3] 287247 0
Study2 - Comparison during walking with and without Tibion leg
Secondary outcome [1] 296813 0
Study1a - Paretic Limb Single-limb (PSLS) support time

PSLS is measured using motion analysis.
Timepoint [1] 296813 0
Study1a - Comparison between with and without Tibion Leg
Secondary outcome [2] 297734 0
Study1b - Knee joint power during sit-to-stand

Joint powers are measured using motion analysis including force plates.
Timepoint [2] 297734 0
Study1b - Comparison between with and without Tibion leg
Secondary outcome [3] 297735 0
Study2 - Paretic Limb Single-limb support time

PSLS is measured using motion analysis.
Timepoint [3] 297735 0
Study2 - Comparison during walking with and without Tibion leg

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 4232 0
United States of America
State/province [1] 4232 0
FL

Funding & Sponsors
Funding source category [1] 285355 0
Commercial sector/Industry
Name [1] 285355 0
Tibion Corporation
Country [1] 285355 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Tibion Corporation
Address
247 Santa Ana Court
Sunnyvale, CA 94085
Country
United States of America
Secondary sponsor category [1] 284204 0
University
Name [1] 284204 0
University of Florida
Address [1] 284204 0
College of Public Health & Health Professions
Department of Physical Therapy
Box 100154, UFHSC
Gainesville, FL 32610-0154
Country [1] 284204 0
United States of America
Secondary sponsor category [2] 284205 0
Government body
Name [2] 284205 0
Department of Veterans Affairs
Address [2] 284205 0
VA Brain Rehabilitation Research Center
Malcom Randall VAMC
1601 SW Archer Rd. (151A)
Gainesville, Florida 32608
Country [2] 284205 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287369 0
University of Florida IRB-01
Ethics committee address [1] 287369 0
IRB-01
Box 100173
Gainesville FL 32610-0173
Ethics committee country [1] 287369 0
United States of America
Date submitted for ethics approval [1] 287369 0
Approval date [1] 287369 0
24/08/2010
Ethics approval number [1] 287369 0

Summary
Brief 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.
Trial website
n/a
Trial related presentations / publications
none to date
Public notes

Contacts
Principal investigator
Name 34003 0
Address 34003 0
Country 34003 0
Phone 34003 0
Fax 34003 0
Email 34003 0
Contact person for public queries
Name 17250 0
Albina Guri
Address 17250 0
Brain Rehabilitation Research Center
1601 SW Archer Rd (151A)
Gainesville, FL 32608
USA
Country 17250 0
United States of America
Phone 17250 0
+1 352 376 1611 x5441
Fax 17250 0
+1 352 379 2332
Email 17250 0
[email protected]
Contact person for scientific queries
Name 8178 0
Carolynn Patten, Ph.D., PT
Address 8178 0
Brain Rehabilitation Research Center
1601 SW Archer Rd (151A)
Gainesville, FL 32608
USA
Country 8178 0
United States of America
Phone 8178 0
+1 352 376 1611 x4160
Fax 8178 0
+1 352 379 2332
Email 8178 0
[email protected]

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No Supporting Document Provided



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