Locomotor Training (Walking Therapy) Post Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00715299
First received: July 10, 2008
Last updated: February 17, 2015
Last verified: February 2015
Results First Received: December 3, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Stroke
Intervention: Behavioral: locomotor training

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Total Locomotor Training Group

persons who have sustained a stroke within greater than 6 months ago and less than 5 years.

locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern.


Participant Flow:   Overall Study
    Total Locomotor Training Group  
STARTED     36 [1]
COMPLETED     30  
NOT COMPLETED     6  
Withdrawal by Subject                 1  
Adverse Event                 3  
failed the pre-screen exercise test                 2  
[1] A total of 38 participants were consented to the study, but only 36 made it to day one of testing.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Individuals greater than 6 months post stroke, 18-80 years of age. Subjects who have experienced more than one stroke will be accepted only if all strokes are on the same side of the brain.

Reporting Groups
  Description
Arm 1

persons who have sustained a stroke within greater than 6 months ago and less than 5 years.

locomotor training: Persons will train 3 times a week for 12 weeks. The training sessions will each last about an hour to an hour and a half. Therapists will manipulate the participant's body to generate stepping and walking that is more consistent with normal walking. Someone will manipulate the trunk by standing at the waist and helping with weight shift and proper upper body mechanics. The other two therapists will sit at the legs and bend and extend them as they should in a more normal gait pattern.


Baseline Measures
    Arm 1  
Number of Participants  
[units: participants]
  36  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     28  
>=65 years     8  
Age  
[units: years]
Mean (Standard Deviation)
  58.7  (13.0)  
Gender  
[units: participants]
 
Female     10  
Male     26  
Region of Enrollment  
[units: participants]
 
United States     36  



  Outcome Measures

1.  Primary:   The Primary Outcome Measure Was Pre-treatment to Post-treatment Change in Self-selected Walking Speed.   [ Time Frame: Pre and post Treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Steve Kautz, PhD, Principal Investigator
Organization: VAHSRD and Medical University of South Carolina
phone: 843-792-3867
e-mail: kautz@musc.edu



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00715299     History of Changes
Other Study ID Numbers: B3983-R
Study First Received: July 10, 2008
Results First Received: December 3, 2014
Last Updated: February 17, 2015
Health Authority: United States: Federal Government