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

NCT01558232 | Terminated

• 1 other identifier: CP001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Tibion; Bionics; Rehab; Therapy; Robotics; Intention

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (1)

Tibion Arm

EXPERIMENTAL

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

Interventions

Tibion Bionic Leg DEVICE

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).

Tibion Arm

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tibion Bionics, Inc.: lead

Study Sites (1)

Magee Rehabilitation Hospital

Philadelphia, Pennsylvania, 19102, United States

Location

Related Publications (3)

• 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.

  PMID: 22082495 BACKGROUND

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

  PMID: 19964374 BACKGROUND

• Horst RW, Marcus RR. FlexCVA: a continuously variable actuator for active orthotics. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:2425-8. doi: 10.1109/IEMBS.2006.259950.

  PMID: 17946511 BACKGROUND

Related Links

• Tibion Bionic Leg

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Barbara Browne, MD

  Magee Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 20, 2012
• Study Start: March 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 9, 2012

Record last verified: 2012-07

Locations

US (1)