Internally Versus Externally Guided Body Weight-Supported Treadmill Training (BWSTT) for Locomotor Recovery Post-stroke
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
|---|---|
|
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 |
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| United States, Florida | |
| North Florida/South Georgia Veterans Health System | |
| Gainesville, Florida, United States, 32608 | |
| Principal Investigator: | Carolynn Patten, PhD | North Florida/South Georgia Veterans Health System |
More Information
No publications provided
| Responsible Party: | Patten, Carolynn - Principal Investigator, Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00125619 History of Changes |
| Other Study ID Numbers: | B4032I |
| Study First Received: | July 28, 2005 |
| Last Updated: | May 20, 2010 |
| 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 Infarction Brain Ischemia Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013