Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Department of Veterans Affairs |
---|---|
Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00125619 |
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: | 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 |
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.
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Carolynn Patten, PhD | North Florida/South Georgia Veterans Health System |
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 |
biomechanics Cerebrovascular Accident electromyography Gait disability stroke |
locomotor therapy muscular weakness reflex variability stroke |
Cerebral Infarction Asthenia Stroke Vascular Diseases Central Nervous System Diseases Ischemia Muscle Weakness |
Brain Diseases Cerebrovascular Disorders Body Weight Brain Ischemia Brain Infarction Infarction |
Nervous System Diseases Cardiovascular Diseases |