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

Sponsor

Tibion Bionics, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT01558232

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Tibion Bionic Leg	N/A

Detailed Description

Samples text.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2012

Anticipated Primary Completion Date :

Aug 1, 2012

Anticipated Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tibion Arm Arm of the study in which enrolled subacute post-stroke subjects undergo lower extremity physical therapy using the Tibion Bionic Leg.	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).

Arm

Intervention/Treatment

Experimental: Tibion Arm

Arm of the study in which enrolled subacute post-stroke subjects undergo lower extremity physical therapy using the Tibion Bionic Leg.

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).

Outcome Measures

Primary Outcome Measures

Ambulation Speed [Baseline (prior to training); at conclusion of training regimen, an average of 2 weeks.]
Walking speed (comfortable and fastest possible), in meters per second, as measured by the 10 Meter Walk Test (10 MWT).

Secondary Outcome Measures

Measurements of Gait [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.]
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.
Measurements of Stride [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.]
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.
Measurements of Force, Stance, and 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.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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