Skip to main content
OpenTrials
Completed

NCT Number: NCT00125619

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Locomotor Training

Behavioral

This study compares two forms of Iocomotor training: 1) standard or manual - in which an individual is provided partial body weight support while walking on a treadmill with assistance of 1-3 therapists to move the legs and stabilize the trunk/pelvis and 2) robotic-guided - in which an exoskeleton robot (Lokomat) guides movement of the walking pattern. Partial body-weight support, treadmill walking and treadmill speed are consistent between the study arms.

Other names: partial body-weight supported treadmill training, body-weight supported treadmill training

Primary outcomes

  1. Self-selected Overground Walking Speed

    Time frame: 4 weeks (s/p 12 sessions of locomotor training)

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

Secondary outcomes

  1. Fast Walking Speed

    Time frame: 4 weeks (s/p 12 training sessions)

    Fastest comfortable walking speed measured while walking overground

  2. Six Minute Walk

    Time frame: 4 weeks

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

  3. Step Length Ratio (Abs)

    Time frame: 4 weeks

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

  4. Lower Extremity Fugl-Meyer Motor Assessment

    Time frame: 4 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.

  5. Short Physical Performance Battery

    Time frame: 4 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.

  6. Berg Balance Scale

    Time frame: 4 weeks

    Clinical measure of balance

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Aug 1, 2005
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.