A Prospective Study to Evaluate Use of the Tibion Bionic Leg in Sub-Acute Post-stroke Patients

Stroke Clinical Trial

— Acute Effects  

Official title:

A Prospective, Experimental ABA Study to Evaluate Use of the Tibion Bionic Leg in Subacute Post-stroke Patients Undergoing Physical Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01558232
• Other study ID #: CP001
• Status: Terminated
• Phase: N/A
• First received: March 6, 2012
• Last updated: July 5, 2012
• Start date: March 2012
• Est. completion date: August 2012

Study information

• Verified date: July 2012
• Source: Tibion Bionics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The objective of this clinical study is to examine acute changes in stability, force allocation, work, and mobility from using a wearable, portable, battery-operated robotic orthosis (the Tibion Bionic Leg) in subacute post-stroke persons undergoing lower extremity physical therapy.

Description:

Samples text.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

• Single stroke with residual unilateral lower-extremity weakness

• Subacute post-stroke period (>3 and <12 months)

• Eligible to participate to lower extremity physical therapy

• Age 40 years or greater

• Able to ambulate at least 10 meters

• Able to ambulate without a leg brace

• Ambulation speed less than 0.8 meters/second

• Minimum to moderate assist for transfer or ambulation by physical therapist evaluation

• Subject must understand the nature of the study and provide written informed consent prior to enrollment.

• Subject must be willing and able to attend all study sessions

Exclusion Criteria:

• Medically unstable

• Age younger than 40 years

• Acute post-stroke (< 3 months)

• Chronic post-stroke (> 12 months)

• Status-post multiple strokes

• Status-post traumatic brain injury

• Ambulation speed greater than 0.8 meters/second

• Currently using a Knee-Ankle-Foot Orthosis (KAFO)

• Not eligible for lower extremity physical therapy

• Concomitant degenerative neurological conditions

• Not able to ambulate at least 10 meters without assistance

• Greater than moderate assist during transfer or ambulation by physical therapist evaluation

• Unable to ambulate without a leg brace

• Unable to follow instructions, complete follow-up, or provide informed consent.

• Currently enrolled in another investigational device or drug trial

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Tibion Bionic Leg
The Tibion Bionic Leg is used as an adjunct in post-stroke and post-operative rehabilitative physical therapy. The leg is a lightweight, wearable, portable, battery-powered, motorized leg orthosis that provides active assistance and resistance to lower limb movement during walking, stair ascent and descent, and transfers from sitting to standing (and standing to sitting).

Locations

Country	Name	City	State
United States	Magee Rehabilitation Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Tibion Bionics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Horst RW, Marcus RR. FlexCVA: a continuously variable actuator for active orthotics. Conf Proc IEEE Eng Med Biol Soc. 2006;1:2425-8. — View Citation

Horst RW. A bio-robotic leg orthosis for rehabilitation and mobility enhancement. Conf Proc IEEE Eng Med Biol Soc. 2009;2009:5030-3. doi: 10.1109/IEMBS.2009.5333581. — View Citation

Wong CK, Bishop L, Stein J. A wearable robotic knee orthosis for gait training: a case-series of hemiparetic stroke survivors. Prosthet Orthot Int. 2012 Mar;36(1):113-20. doi: 10.1177/0309364611428235. Epub 2011 Nov 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulation Speed	Walking speed (comfortable and fastest possible), in meters per second, as measured by the 10 Meter Walk Test (10 MWT).	Baseline (prior to training); at conclusion of training regimen, an average of 2 weeks.	Yes
Secondary	Measurements of Gait	The secondary endpoints are obtained from the GAITRite analysis system: Measurements of gait, such as the length and time of step, cycle, and stride, Heel to Heel base support, single/double limb support time, and stance and swing phase timing.	Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.	Yes
Secondary	Measurements of Stride	Other secondary endpoints are obtained from the GAITRite analysis system: Measurements of Stride such as distance, ambulation time, velocity, normalized velocity, cadence, step time, step length, cycle time.	Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.	Yes
Secondary	Measurements of Force, Stance, and Stability	Other secondary endpoints are obtained from Balance Master system: Limb parameters, including force in transfers from sitting to standing, standing to sitting, weight-bearing squats, and limits of stability.	Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.	Yes

External Links

•   Tibion Bionic Leg