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Internally Versus Externally Guided Body Weight-Supported Treadmill Training (BWSTT) for Locomotor Recovery Post-Stroke
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, January 2009
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00125619
  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
Cerebrovascular Accident
Behavioral: Rehabilitation: Two Forms of Locomotor Training for Gait

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Single Blind (Subject), Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title: Internally v. Externally Guided BWSTT for Locomotor Recovery Post-Stroke

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Physiological and biomechanical effects of Body Weight Supported Treadmill Training [ Time Frame: 20 Weeks plus a 6 month follow-up. ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: September 2005
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Post-Stroke hemiparesis
Behavioral: Rehabilitation: Two Forms of Locomotor Training for Gait
Individuals receive locomotor training on two devices - a treadmill with body weight support while therapists assist the movement of the paretic leg and a robotic device called the Lokomat that moves your legs over a treadmill with body weight support.

Detailed Description:

The investigators hypothesize that key differences are present in both biomechanical (i.e., loading, kinetic energy at toe off, trunk energetic cost, muscle tendon lengthening velocity) and physiological (i.e., temporal patterning of intermuscular electromyogram [EMG], central reflex modulation) constituents of locomotion between internally and externally-driven modes of BWSTT. Externally-driven BWSTT (Lokomat) produces a more controlled, consistent and mechanically appropriate locomotor pattern promoting positive adaptation in the spinal locomotor circuitry and improved integration of descending motor drive which in combination promote improved gait dynamics. These therapeutically-induced differences will be manifest in the ability to generalize the effects of BWSTT to overground locomotion and will include: improved gait symmetry, increased knee flexion during swing phase, normalization of limb kinetic energy at the stance-to-swing transition, and the ability to scale gait speed effectively between self-selected and fast speeds. The investigators further hypothesize that externally-driven BWSTT will produce more persistent treatment-related effects.

In this pilot study, the investigators will conduct a series of twelve single-case, ABA or BAB, designs in which hemiparetic subjects will experience both internally and externally-driven BWSTT. Training parameters (i.e., body weight support, treadmill speed and support stiffness) will be held constant between modes of BWSTT and physiological and biomechanical responses will be compared between modes for individual subjects. Adaptations in overground gait parameters (i.e., limb kinetic energy at toe off, knee flexion, trunk mechanical energetic cost, gait symmetry, gait speed) will be compared using reference normal gait data obtained from non-disabled, age and gender-matched control subjects walking at matched speeds. The response of non-disabled control subjects to both forms of BWSTT will also be studied.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125619

Contacts
Contact: Jeff D Fox (352) 376-1611 ext 5989 jeffrey.fox@va.gov
Contact: Carolynn Patten, PhD (352) 376-1611 ext 4160 patten@phhp.ufl.edu

Locations
United States, Florida
North Florida/South Georgia Veterans Health System Recruiting
Gainesville, Florida, United States, 32608
Contact: Jeff D Fox     352-376-1611 ext 5989     jeffrey.fox@va.gov    
Principal Investigator: Carolynn Patten, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: Carolynn Patten, PhD North Florida/South Georgia Veterans Health System
  More Information

Publications of Results:
Responsible Party: Department of Veterans Affairs ( Patten, Carolynn - Principal Investigator )
Study ID Numbers: B4032I
Study First Received: July 28, 2005
Last Updated: January 7, 2009
ClinicalTrials.gov Identifier: NCT00125619  
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
biomechanics
Cerebrovascular Accident
electromyography
Gait disability stroke
locomotor therapy
muscular weakness
reflex variability stroke

Study placed in the following topic categories:
Cerebral Infarction
Asthenia
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Muscle Weakness
Brain Diseases
Cerebrovascular Disorders
Body Weight
Brain Ischemia
Brain Infarction
Infarction

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009