NCT01626417

Brief Summary

The objective of this clinical study is to examine the acute kinematics and kinetics of utilizing the Tibion Bionic Leg in a sample of chronic post-stroke patients performing sit-to-stand and stand-to-sit transfers across a range of assistance and resistance settings (internal to the device); to compare these metrics to baseline performance without the Bionic Leg; and to determine the Bionic Leg settings that optimize a restorative (equal force distribution) movement state in these patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started May 2012

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 22, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 14, 2012

Status Verified

November 1, 2012

Enrollment Period

6 months

First QC Date

June 18, 2012

Last Update Submit

November 13, 2012

Conditions

Stroke

Keywords

StrokeTibionBionicsRehabTherapyRoboticsIntention

Outcome Measures

Primary Outcomes (1)

  • Force

    Force, in Newtons (N), by limb, as measured by kinematic and kinetic analysis during sit-to-stand and stand-to-sit transfers with and without the Tibion Bionic Leg.

    Subject participation in the study is up to one (1) week.

Secondary Outcomes (3)

  • Work

    Subject participation in study is up to one (1) week.

  • Torque

    Subject participation is up to one (1) week

  • Moment

    Subject participation is up to one (1) week

Study Arms (1)

Patient Population

NO INTERVENTION

Chronic post-stroke subjects with varied impairment level, who have completed routine rehabilitative physical therapy.

Device: Tibion Bionic Leg

Interventions

Tibion Bionic LegDEVICE

The device is a lightweight, wearable, portable, battery-powered, robotic leg orthosis that provides active assistance and resistance to lower limb movement according to the patient's intent to move.

Patient Population

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Single ischemic stroke with residual unilateral lower-extremity weakness
  • Chronic post-stroke (\>12 months since event)
  • Eligible to participate to lower extremity physical therapy
  • Age 30 years or greater
  • Able to ambulate at least 10 meters without therapist assistance
  • Able to ambulate without a leg brace
  • Able to transfer from sitting to standing without physical assistance from a therapist
  • Able to transfer from standing to sitting without physical assistance from a therapist
  • 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 30 years
  • Subacute post-stroke (\< 12 months since event)
  • Status-post multiple strokes
  • Status-post traumatic brain injury
  • Not eligible to participate in lower extremity physical therapy
  • Concomitant degenerative neurological conditions
  • Not able to ambulate at least 10 meters without therapist assistance
  • Unable to ambulate without a leg brace
  • Unable to transfer from sitting to standing without physical assistance from a therapist
  • Unable to transfer from standing to sitting without physical assistance from a therapist
  • Unable to follow instructions, complete follow-up, or provide informed consent.
  • Currently enrolled in another investigational device or drug trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCSF Human Performance Center

San Francisco, California, 94158, United States

Location

Tibion Corporation

Sunnyvale, California, 94085, 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: 22082495BACKGROUND

  • 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: 19964374BACKGROUND

  • 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: 17946511BACKGROUND

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Joshua G Vose, MD

    Tibion Corporation

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 18, 2012

First Posted

June 22, 2012

Study Start

May 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 14, 2012

Record last verified: 2012-11

Locations

US(2)