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

December 23, 2016 updated by: VA Office of Research and Development

Internally v. Externally Guided 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • North Florida/South Georgia Veterans Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1: Therapist assisted
Therapist assisted locomotor training (partial body-weight supported)
Behavioral: Locomotor training
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
Experimental: Arm 2: Robot-assisted
Robot-assisted locomotor training (partial body-weight supported)
Behavioral: Locomotor training
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks (s/p 12 sessions of locomotor training)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fast Walking Speed
Time Frame: 4 weeks (s/p 12 training sessions)
Fastest comfortable walking speed measured while walking overground
4 weeks (s/p 12 training sessions)
Six Minute Walk
Time Frame: 4 weeks
distance, in meters, walked overground over a six minute interval.
4 weeks
Step Length Ratio (Abs)
Time Frame: 4 weeks
measure of step length symmetry, calculated as = ABS [1 - (Pstep length / NPstep length)]
4 weeks
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.
4 weeks
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.
4 weeks
Berg Balance Scale
Time Frame: 4 weeks
Clinical measure of balance
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Carolynn Patten, PhD, North Florida/South Georgia Veterans Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

July 28, 2005

First Submitted That Met QC Criteria

July 28, 2005

First Posted (Estimate)

August 1, 2005

Study Record Updates

Last Update Posted (Actual)

February 17, 2017

Last Update Submitted That Met QC Criteria

December 23, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B4032-I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe