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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:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00125619
First received: July 28, 2005
Last updated: December 23, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention
Stroke Behavioral: Locomotor training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internally v. Externally Guided BWSTT for Locomotor Recovery Post-stroke

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 16
Study Start Date: September 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1: Therapist assisted
Therapist assisted locomotor training (partial body-weight supported)
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
Experimental: Arm 2: Robot-assisted
Robot-assisted locomotor training (partial body-weight supported)
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125619

Locations
United States, Florida
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Carolynn Patten, PhD North Florida/South Georgia Veterans Health System
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00125619     History of Changes
Other Study ID Numbers: B4032-I
Study First Received: July 28, 2005
Results First Received: April 17, 2015
Last Updated: December 23, 2016

Keywords provided by VA Office of Research and Development:
biomechanics
stroke
electromyography
Gait disability stroke
locomotor therapy
muscular weakness
reflex variability stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 17, 2017