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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):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00125619
First received: July 28, 2005
Last updated: October 27, 2014
Last verified: October 2014
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 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
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
Investigators
Principal Investigator: Carolynn Patten, PhD North Florida/South Georgia Veterans Health System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00125619     History of Changes
Other Study ID Numbers: B4032-I
Study First Received: July 28, 2005
Last Updated: October 27, 2014
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

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

ClinicalTrials.gov processed this record on November 27, 2014