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

Not Applicable
Completed
Conditions
Stroke
Interventions
Behavioral: Locomotor training
Registration Number
NCT00125619
Lead Sponsor
VA Office of Research and Development
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
16
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Arm 1: Therapist assistedLocomotor trainingTherapist assisted locomotor training (partial body-weight supported)
Arm 2: Robot-assistedLocomotor trainingRobot-assisted locomotor training (partial body-weight supported)
Primary Outcome Measures
NameTimeMethod
Self-selected Overground Walking Speed4 weeks (s/p 12 sessions of locomotor training)

Overground walking speed determined as rate of walking over a 10 meter distance.

Secondary Outcome Measures
NameTimeMethod
Six Minute Walk4 weeks

distance, in meters, walked overground over a six minute interval.

Fast Walking Speed4 weeks (s/p 12 training sessions)

Fastest comfortable walking speed measured while walking overground

Step Length Ratio (Abs)4 weeks

measure of step length symmetry, calculated as = ABS \[1 - (Pstep length / NPstep length)\]

Berg Balance Scale4 weeks

Clinical measure of balance

Lower Extremity Fugl-Meyer Motor Assessment4 weeks

Standardized clinical measure of motor impairment. The lower extremity (leg) sub-scale ranges from 0 - 35 points, where less impairment corresponds with scores approaching 35 and worse impairment corresponds with scores approaching 0.

Short Physical Performance Battery4 weeks

Standardized clinical measure of physical function involving tests of: walking speed, strength (repeated chair rise), and balance. The scale ranges from 0 - 12 points with better physical function as the score approaches 12 points and worse physical function as the score approaches 0 points.

Trial Locations

Locations (1)

North Florida/South Georgia Veterans Health System

🇺🇸

Gainesville, Florida, United States

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