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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Locomotor training
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring biomechanics, stroke, electromyography, Gait disability stroke, locomotor therapy, muscular weakness, reflex variability stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • North Florida/South Georgia Veterans Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm 1: Therapist assisted

Arm 2: Robot-assisted

Arm Description

Therapist assisted locomotor training (partial body-weight supported)

Robot-assisted locomotor training (partial body-weight supported)

Outcomes

Primary Outcome Measures

Self-selected Overground Walking Speed
Overground walking speed determined as rate of walking over a 10 meter distance.

Secondary Outcome Measures

Fast Walking Speed
Fastest comfortable walking speed measured while walking overground
Six Minute Walk
distance, in meters, walked overground over a six minute interval.
Step Length Ratio (Abs)
measure of step length symmetry, calculated as = ABS [1 - (Pstep length / NPstep length)]
Lower Extremity Fugl-Meyer Motor Assessment
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 Battery
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.
Berg Balance Scale
Clinical measure of balance

Full Information

First Posted
July 28, 2005
Last Updated
December 23, 2016
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00125619
Brief Title
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

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
biomechanics, stroke, electromyography, Gait disability stroke, locomotor therapy, muscular weakness, reflex variability stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Therapist assisted
Arm Type
Active Comparator
Arm Description
Therapist assisted locomotor training (partial body-weight supported)
Arm Title
Arm 2: Robot-assisted
Arm Type
Experimental
Arm Description
Robot-assisted locomotor training (partial body-weight supported)
Intervention Type
Behavioral
Intervention Name(s)
Locomotor training
Other Intervention Name(s)
partial body-weight supported treadmill training, body-weight supported treadmill training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-selected Overground Walking Speed
Description
Overground walking speed determined as rate of walking over a 10 meter distance.
Time Frame
4 weeks (s/p 12 sessions of locomotor training)
Secondary Outcome Measure Information:
Title
Fast Walking Speed
Description
Fastest comfortable walking speed measured while walking overground
Time Frame
4 weeks (s/p 12 training sessions)
Title
Six Minute Walk
Description
distance, in meters, walked overground over a six minute interval.
Time Frame
4 weeks
Title
Step Length Ratio (Abs)
Description
measure of step length symmetry, calculated as = ABS [1 - (Pstep length / NPstep length)]
Time Frame
4 weeks
Title
Lower Extremity Fugl-Meyer Motor Assessment
Description
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.
Time Frame
4 weeks
Title
Short Physical Performance Battery
Description
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.
Time Frame
4 weeks
Title
Berg Balance Scale
Description
Clinical measure of balance
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolynn Patten, PhD
Organizational Affiliation
North Florida/South Georgia Veterans Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Florida/South Georgia Veterans Health System
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19523207
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.
Results Reference
result
PubMed Identifier
22446153
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.
Results Reference
result

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

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