Internally Versus Externally Guided Body Weight-Supported Treadmill

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00125619
Study type	Interventional
Source	VA Office of Research and Development
Contact
Status	Completed
Phase	N/A
Start date	September 2005
Completion date	December 2009

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Internally Versus Externally Guided Body Weight-Supported Treadmill Training (BWSTT) for Locomotor Recovery Post-stroke

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms