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

Completed

Phase N/A Results N/A

Trial Description

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.

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.

Conditions

Interventions

  • Robotic Aids Behavioral
    Intervention Desc: This category includes any mechanical and/or computerized device designed to improve extremity function.
  • Rehabilitation: Two Forms of Locomotor Training for Gait Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: 1
    Description: Post-Stroke hemiparesis
    ARM 2: Kind: Experimental
    Label: Arm 1
    Description: Post-Stroke hemiparesis

Trial Design

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

Patient Involvement

All hemiparetic patients will experience both internally and externally-driven BWSTT through a series of twelve single-case, ABA or BAB treatment designs.

Outcomes

Type Measure Time Frame Safety Issue
Primary 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 Gait kinematics and kinetics; 6:00 timed walk; Stroke Impact Scale; Beck Depression Scale.
Primary Physiological and biomechanical effects of Body Weight Supported Treadmill Training 20 Weeks plus a 6 month follow-up. No

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