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

Cerebrovascular Accident Clinical Trial

Official title:

Internally v. Externally Guided BWSTT for Locomotor Recovery Post-stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00125619
• Other study ID #: B4032-I
• Status: Completed
• Phase: N/A
• First received: July 28, 2005
• Last updated: October 27, 2014
• Start date: September 2005
• Est. completion date: December 2009

Study information

• Verified date: October 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

• Cerebrovascular Accident
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	North Florida/South Georgia Veterans Health System	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

Spiess MR, Jaramillo JP, Behrman AL, Teraoka JK, Patten C. Unexpected recovery after robotic locomotor training at physiologic stepping speed: a single-case design. Arch Phys Med Rehabil. 2012 Aug;93(8):1476-84. doi: 10.1016/j.apmr.2012.02.030. Epub 2012 — View Citation

Westlake KP, Patten C. Pilot study of Lokomat versus manual-assisted treadmill training for locomotor recovery post-stroke. J Neuroeng Rehabil. 2009 Jun 12;6:18. doi: 10.1186/1743-0003-6-18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiological and biomechanical effects of Body Weight Supported Treadmill Training		20 Weeks plus a 6 month follow-up.	No