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Internally Versus Externally Guided Body Weight-Supported Treadmill Training (BWSTT) for Locomotor Recovery Post-stroke

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00125619
First Posted: August 1, 2005
Last Update Posted: February 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
July 28, 2005
August 1, 2005
April 17, 2015
February 17, 2017
February 17, 2017
September 2005
December 2009   (Final data collection date for primary outcome measure)
Self-selected Overground Walking Speed [ Time Frame: 4 weeks (s/p 12 sessions of locomotor training) ]
Overground walking speed determined as rate of walking over a 10 meter distance.
Overground gait speed and gait dependency following each treatment and at six months post-intervention, Health-related quality of life (Reintegration to Normal Living Scale).
Complete list of historical versions of study NCT00125619 on ClinicalTrials.gov Archive Site
  • Fast Walking Speed [ Time Frame: 4 weeks (s/p 12 training sessions) ]
    Fastest comfortable walking speed measured while walking overground
  • Six Minute Walk [ Time Frame: 4 weeks ]
    distance, in meters, walked overground over a six minute interval.
  • Step Length Ratio (Abs) [ Time Frame: 4 weeks ]
    measure of step length symmetry, calculated as = ABS [1 - (Pstep length / NPstep length)]
  • Lower Extremity Fugl-Meyer Motor Assessment [ Time Frame: 4 weeks ]
    Standardized clinical measure of motor impairment. The lower extremity (leg) sub-scale ranges from 0 - 35 points, where less impairment corresponds with scores approaching 35 and worse impairment corresponds with scores approaching 0.
  • Short Physical Performance Battery [ Time Frame: 4 weeks ]
    Standardized clinical measure of physical function involving tests of: walking speed, strength (repeated chair rise), and balance. The scale ranges from 0 - 12 points with better physical function as the score approaches 12 points and worse physical function as the score approaches 0 points.
  • Berg Balance Scale [ Time Frame: 4 weeks ]
    Clinical measure of balance
Gait kinematics and kinetics, 6:00 timed walk, Stroke Impact Scale, Beck Depression Scale
Not Provided
Not Provided
 
Internally Versus Externally Guided Body Weight-Supported Treadmill Training (BWSTT) for Locomotor Recovery Post-stroke
Internally v. Externally Guided BWSTT for Locomotor Recovery Post-stroke
The overriding goal of this proposal is to identify the critical physiological and biomechanical effects of BWSTT for promoting improved locomotor function in persons with post-stroke hemiparesis.

In this pilot study, we tested two forms of locomotor training for gait rehabilitation in persons post-stroke: traditional locomotor training (partial body-weight support and manual assistance of therapists) vs. robotic-assisted locomotor training (partial body-weight support and robotic guidance with the Lokomat). We enrolled 16 persons with chronic (>6 months) hemiparesis post-stroke who were randomized to traditional/manual or robotic locomotor training. All individuals received 12 sessions (thrice weekly for four weeks) of training. Each session involved 30 minutes of stepping.

The complete study results are published.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Stroke
Behavioral: Locomotor training
This study compares two forms of Iocomotor training: 1) standard or manual - in which an individual is provided partial body weight support while walking on a treadmill with assistance of 1-3 therapists to move the legs and stabilize the trunk/pelvis and 2) robotic-guided - in which an exoskeleton robot (Lokomat) guides movement of the walking pattern. Partial body-weight support, treadmill walking and treadmill speed are consistent between the study arms.
Other Name: partial body-weight supported treadmill training, body-weight supported treadmill training
  • Active Comparator: Arm 1: Therapist assisted
    Therapist assisted locomotor training (partial body-weight supported)
    Intervention: Behavioral: Locomotor training
  • Experimental: Arm 2: Robot-assisted
    Robot-assisted locomotor training (partial body-weight supported)
    Intervention: Behavioral: Locomotor training

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
December 2009
December 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of cerebrovascular accident
  • Single event
  • Unilateral hemiplegia
  • Locomotor disability
  • Ability to walk independently 25' on level ground (may use an assistive device [cane or walker]; may NOT use a brace)
  • Cognitive ability to follow 3-step commands

Exclusion Criteria:

  • Unstable or uncontrolled blood pressure
  • Uncontrolled seizures
  • Severe cognitive impairment
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00125619
B4032-I
No
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Carolynn Patten, PhD North Florida/South Georgia Veterans Health System
VA Office of Research and Development
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP