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Improving Ambulation Post Stroke With Robotic Training

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Therapy
Lokomat
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects with ischemic or hemorrhagic stroke confirmed by cerebral computed tomography (CT) or magnetic resonance imaging (MRI) scan
  • Age>18
  • At least 3 months post stroke at time of enrollment into study
  • Ability to walk at least 10 feet with maximum 1 person assist, but not to walk in the community independently
  • Residual paresis in the lower extremity as defined by the National Institute of Health Stroke Scale lower extremity motor score 2-4
  • Ability to perform Lokomat ambulation training with assistance of 1 therapist
  • Ability to follow a three-step command
  • Physician approval for patient participation
  • Ability to give informed consent
  • Completed their rehabilitation services, i.e., receiving no concurrent physical, occupational, or speech therapies

Exclusion Criteria:

  • Serious cardiac condition
  • Uncontrolled blood pressure, defined as > 200 or diastolic > 100 at rest
  • Hx of serious chronic obstructive pulmonary disease or oxygen dependence
  • Sever weight bearing pain
  • Lower extremity amputation
  • Claudication while walking
  • Life expectancy < 1 year
  • History of deep vein thrombosis/pulmonary embolism (DVT/PE) within 6 months
  • Severe orthopedic problem
  • Any medical or psychiatric condition that the investigators believe would make the patient unable to participate in this study

Sites / Locations

  • Memorial Hermann

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lokomat Intervention

Standard of Care

Arm Description

Lokomat gait training (five days a week for eight weeks for a total of 40 sessions).

Conventional physical therapy focusing on gait training for five days a week for eight weeks for a total of 40 sessions.

Outcomes

Primary Outcome Measures

10-meter Walking Test (10mWT)

Secondary Outcome Measures

6 Minute Walking Distance (6MWD)

Full Information

First Posted
September 10, 2009
Last Updated
February 20, 2013
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT00975156
Brief Title
Improving Ambulation Post Stroke With Robotic Training
Official Title
Improving Ambulation Post Stroke With Robotic Training
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research study is to look at a new rehabilitation technique for individuals who have suffered a stroke and have difficulties walking. This study is designed to compare robot-assisted (Lokomat) rehabilitation therapy with standard physical therapy in order to improve walking post-stroke. This research project will be conducted as a pilot randomized controlled trial that compares the effectiveness of Lokomat versus conventional physical therapy in improving the ambulation and gait of chronic stroke patients. The project will provide important pilot data that could indicate whether or not the effectiveness of Lokomat training is superior to that of standard physical therapy and if a definitive and larger clinical trial is warranted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lokomat Intervention
Arm Type
Experimental
Arm Description
Lokomat gait training (five days a week for eight weeks for a total of 40 sessions).
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Conventional physical therapy focusing on gait training for five days a week for eight weeks for a total of 40 sessions.
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Intervention Description
Conventional physical therapy
Intervention Type
Device
Intervention Name(s)
Lokomat
Intervention Description
Robotic-assisted walking device
Primary Outcome Measure Information:
Title
10-meter Walking Test (10mWT)
Time Frame
Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention
Secondary Outcome Measure Information:
Title
6 Minute Walking Distance (6MWD)
Time Frame
Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with ischemic or hemorrhagic stroke confirmed by cerebral computed tomography (CT) or magnetic resonance imaging (MRI) scan Age>18 At least 3 months post stroke at time of enrollment into study Ability to walk at least 10 feet with maximum 1 person assist, but not to walk in the community independently Residual paresis in the lower extremity as defined by the National Institute of Health Stroke Scale lower extremity motor score 2-4 Ability to perform Lokomat ambulation training with assistance of 1 therapist Ability to follow a three-step command Physician approval for patient participation Ability to give informed consent Completed their rehabilitation services, i.e., receiving no concurrent physical, occupational, or speech therapies Exclusion Criteria: Serious cardiac condition Uncontrolled blood pressure, defined as > 200 or diastolic > 100 at rest Hx of serious chronic obstructive pulmonary disease or oxygen dependence Sever weight bearing pain Lower extremity amputation Claudication while walking Life expectancy < 1 year History of deep vein thrombosis/pulmonary embolism (DVT/PE) within 6 months Severe orthopedic problem Any medical or psychiatric condition that the investigators believe would make the patient unable to participate in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Noser, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Improving Ambulation Post Stroke With Robotic Training

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