Clinical trial NCT00125619: Internally Versus Externally Guided Body Weight-Supported Treadmill Training (BWSTT) for Locomotor Recovery Post-stroke
Official title: Internally v. Externally Guided BWSTT for Locomotor Recovery Post-stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: biomechanics
stroke
electromyography
Gait disability stroke
locomotor therapy
muscular weakness
reflex variability stroke
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-08-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: In this pilot study, we tested two forms of locomotor training for gait rehabilitation in persons post-stroke: traditional locomotor training (partial body-weight support and manual assistance of therapists) vs. robotic-assisted locomotor training (partial body-weight support and robotic guidance with the Lokomat). We enrolled 16 persons with chronic (\>6 months) hemiparesis post-stroke who were randomized to traditional/manual or robotic locomotor training. All individuals received 12 sessions (thrice weekly for four weeks) of training. Each session involved 30 minutes of stepping.

The complete study results are published.

Eligibility 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

Primary outcomes:
measure: Self-selected Overground Walking Speed
timeFrame: 4 weeks (s/p 12 sessions of locomotor training)
Secondary outcomes:
measure: Fast Walking Speed
timeFrame: 4 weeks (s/p 12 training sessions)
measure: Six Minute Walk
timeFrame: 4 weeks
measure: Step Length Ratio (Abs)
timeFrame: 4 weeks
measure: Lower Extremity Fugl-Meyer Motor Assessment
timeFrame: 4 weeks
measure: Short Physical Performance Battery
timeFrame: 4 weeks
measure: Berg Balance Scale
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System
state: Florida
Study officials:
affiliation: North Florida/South Georgia Veterans Health System
name: Carolynn Patten, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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 Mar 23.