Mobility Training Using a Bionic Knee Orthosis in Patients Chronic Post-Stroke: A Case Series

NCT01499862 | Completed Phase 4 Results

• 1 other identifier: CP 0003
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study examined the effect of task-oriented mobility training in three persons chronic post-stroke using a novel, wearable, mobile intention-based robotic orthosis (Tibion Bionic Leg).

Conditions

Stroke

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Ambulation Speed

  Ambulation speed, in meters per second, as obtained by the Ten (10) Meter Walk Test (10 MWT). The 10 MWT measures the time required to walk 10 meters at the subject's comfortable walking pace.

  Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.

Secondary Outcomes (4)

• 6 Minute Walk Test (6 MWT)

  Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.

• Timed Up and Go (TUG) Test

  Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.

• Five Times Sit to Stand Test (5 x STS)

  Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.

• Step Length

  Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.

Study Arms (1)

Tibion Arm

EXPERIMENTAL

Arm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with the Tibion Bionic Leg.

Device: Tibion Bionic Leg

Interventions

Tibion Bionic Leg DEVICE

A programmable, carbon-fiber robotic leg orthosis (Tibion Bionic Leg, Tibion Corporation, Sunnyvale, CA) was used during therapy to actively supplement concentric and eccentric quadriceps function on the participant's impaired side. The device uses internal sensors at the foot and knee joint to detect intention of movement and, once a variable force threshold is passed, the devices provides appropriate assistive and resistive adjustments.

Tibion Arm

Eligibility Criteria

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

You may qualify if:

• Male or female
• Aged 40 to 60 years
• One year status post-stroke
• Able to walk at least 10 meters
• Independence in self-care

You may not qualify if:

• Medically unstable
• Major cardiopulmonary deficiency
• Major depression
• Significant cognitive deficit
• Currently receiving gait training
• Younger than 40 years of age
• Older than 60 years of age
• Unable to walk at least 10 meters

Sponsors & Collaborators

• Tibion Bionics, Inc.: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Bakar Community Center at the University of California San Francisco

San Francisco, California, 94158-2332, United States

Location

Related Publications (1)

• 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

Related Links

• Tibion Bionic Technologies

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

These results are from a small group (n of 3) of patients and should not be assumed to be consistent across all populations. Furthermore, the inherent subjective variability of patient response in physical therapy interventions should be considered.

Results Point of Contact

• Title: Dr. Nancy N. Byl
• Organization: Department of Physical Therapy and Rehabilitation, University of California San Francisco

byln@ptrehab.ucsf.edu

415-514-4816

Study Officials

• Nancy N Byl, PhD, PT

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 26, 2011
• Study Start: June 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 2, 2013
• Results First Posted: August 2, 2013

Record last verified: 2013-06

Locations

US (1)