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Long Term Split Belt Treadmill Training for Stroke Recovery

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ClinicalTrials.gov Identifier: NCT01646216
Recruitment Status : Completed
First Posted : July 20, 2012
Results First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
University of Maryland
VA Office of Research and Development
Information provided by (Responsible Party):
Amy J. Bastian, Ph.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Stroke
Hemiparesis
Intervention: Behavioral: Split belt treadmill

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All subjects recruited were 6 months or more post stroke. During 2012-2016 recruitment was done by the following means: Subjects were referred by local physicians and recruited from databases of previous studies. Flyers were disseminated locally. Presentations were made at local stroke support groups.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were enrolled and randomly assigned to either Split or Tied treadmill training groups.

Reporting Groups
  Description
Split-belt Treadmill Exercise

Split-belt treadmill training

Split belt treadmill: A split belt treadmill is like a typical treadmill that is seen in the gym, except that this treadmill has two belts that move instead of just one. One leg goes on one belt and the other leg uses the other belt. The belt speeds can be set to move at the same speed, making this treadmill similar to any regular treadmill, but, belt speeds can also be set so that one belt moves a little faster than the other. The belts are never set at a running or jogging speed, only a self-paced walking speed regardless of whether the belts are both going the same or slightly different speeds.

Tied-belt Treadmill Exercise

Tied-belt treadmill training

The treadmill is run like a typical treadmill that is seen in the gym except that this treadmill has two belts that move instead of just one. One leg goes on one belt and the other leg uses the other belt. The belt speeds are set to move at the same speed, making this treadmill training group similar to any regular treadmill.


Participant Flow:   Overall Study
    Split-belt Treadmill Exercise   Tied-belt Treadmill Exercise
STARTED   17   17 
COMPLETED   6   4 
NOT COMPLETED   11   13 
Baseline step length difference (<5cm)                10                10 
Did not complete training                0                2 
Investigator decision                1                1 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Split-belt Treadmill Exercise

Split-belt treadmill training

Split belt treadmill: A split belt treadmill is like a typical treadmill that is seen in the gym, except that this treadmill has two belts that move instead of just one. One leg goes on one belt and the other leg uses the other belt. The belt speeds can be set to move at the same speed, making this treadmill similar to any regular treadmill, but, belt speeds can also be set so that one belt moves a little faster than the other. The belts are never set at a running or jogging speed, only a self-paced walking speed regardless of whether the belts are both going the same or slightly different speeds.

Tied-belt Treadmill Exercise

Tied-belt treadmill training

The treadmill is run like a typical treadmill that is seen in the gym except that this treadmill has two belts that move instead of just one. One leg goes on one belt and the other leg uses the other belt. The belt speeds are set to move at the same speed, making this treadmill training group similar to any regular treadmill.

Total Total of all reporting groups

Baseline Measures
   Split-belt Treadmill Exercise   Tied-belt Treadmill Exercise   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   4   10 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.8  (11.7)   59.2  (14.3)   60  (13) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      1  25.0%      1  10.0% 
Male      6 100.0%      3  75.0%      9  90.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      6 100.0%      4 100.0%      10 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      1  25.0%      1  10.0% 
White      6 100.0%      3  75.0%      9  90.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   6   4   10 


  Outcome Measures

1.  Primary:   Change in Baseline Step Length Symmetry. That is, Whether the Steps With Right and Left Legs Are the Same Length.   [ Time Frame: After training (week 14), and 3 months after training ]

2.  Secondary:   Change in Baseline Oxygen Intake   [ Time Frame: Post training (week 14), and 3 months follow up ]

3.  Secondary:   Walking Speed   [ Time Frame: Baseline, post training, and 3 month follow up. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
Some subjects could not complete all of the tasks. Recruitment was also challenging.


  More Information

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: Anthony Gonzalez
Organization: Kennedy Krieger Institute
phone: 4439080074
e-mail: gonzalezan@kennedykrieger.org



Responsible Party: Amy J. Bastian, Ph.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier: NCT01646216     History of Changes
Other Study ID Numbers: NA_00068967
2P30AG028747-06 ( U.S. NIH Grant/Contract )
First Submitted: April 5, 2012
First Posted: July 20, 2012
Results First Submitted: December 1, 2017
Results First Posted: May 4, 2018
Last Update Posted: May 4, 2018