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	Phase
Cerbrovascular accident	Behavior: Rehabilitation:Two forms of Locomotor Training for Gait	Phase I Phase II

Further Study Details: 

Primary Outcomes: Overground gait speed and gait dependency following each treatment and at six months post-intervention, Health-related quality of life (Reintegration to Normal Living Scale).
Secondary Outcomes: Gait kinematics and kinetics, 6:00 timed walk, Stroke Impact Scale, Beck Depression Scale
Expected Total Enrollment:  12

We 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 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. We further hypothesize that externally-driven BWSTT will produce more persistent treatment-related effects. In this pilot study, we 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 above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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 -

Please refer to this study by ClinicalTrials.gov identifier  NCT00125619

Jody Dozono, MPT      650-493-5000  Ext. 65972    dozono@rrd.stanford.edu
Abigal M Andrade, BS, PTA      650-493-5000  Ext. 64474    aandrade@va51.stanford.edu

California
      VA Palo Alto Rehabilitation R&D Center, Palo Alto,  California,  94304,  United States

Study chairs or principal investigators

Carolynn Patten, Ph.d., P.T.,  Principal Investigator,  Rehabilitation R&D Center, VA Palo Alto HCS   

Study ID Numbers:  B4032
Last Updated:  August 1, 2005
Record first received:  July 29, 2005
ClinicalTrials.gov Identifier:  NCT00125619
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-02