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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
Enrollment 34
Recruitment Details 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 Subjects were enrolled and randomly assigned to either Split or Tied treadmill training groups.
Arm/Group Title Split-belt Treadmill Exercise Tied-belt Treadmill Exercise
Hide Arm/Group Description

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 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.

Period Title: Overall Study
Started 17 17
Completed 6 4
Not Completed 11 13
Reason Not Completed
Baseline step length difference (<5cm)             10             10
Did not complete training             0             2
Investigator decision             1             1
Arm/Group Title Split-belt Treadmill Exercise Tied-belt Treadmill Exercise Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 6 4 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 4 participants 10 participants
60.8  (11.7) 59.2  (14.3) 60  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 10 participants
Female
0
   0.0%
1
  25.0%
1
  10.0%
Male
6
 100.0%
3
  75.0%
9
  90.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 10 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 10 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 4 participants 10 participants
6 4 10
1.Primary Outcome
Title Change in Baseline Step Length Symmetry. That is, Whether the Steps With Right and Left Legs Are the Same Length.
Hide Description Subjects will either walk on a special mat that records their step lengths, or will wear special markers on the feet and body to record their step lengths.
Time Frame After training (week 14), and 3 months after training
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects were grouped by baseline walking speed into three levels of disability: mild, moderate, and severe.
Arm/Group Title Split-belt, Mild Disability Split-belt, Moderate Disability Split-belt Severe Disability Tied-belt, Severe Disability Tied-belt Mild Disability
Hide Arm/Group Description:
Subjects trained on split belt treadmill. Subjects in the mild disability group had baseline walking speeds greater than 0.8 m/s. There were two subjects in this group.
Subjects trained on split belt treadmill. Subjects in the moderate disability group had baseline walking speeds of 0.4 m/s to 0.8 m/s. There were two subjects in this group.
Subjects trained on split belt treadmill. Subjects in the severe disability group had baseline walking speeds less than 0.4 m/s. There were two subjects in this group.
Subjects trained on tied belt treadmill. Subjects in the severe disability group had baseline walking speeds less than 0.4 m/s. There were three subjects in this group.
Subjects trained on tied belt treadmill. Subjects in the mild disability group had baseline walking speeds greater than 0.8 m/s. There was one subject in this group.
Overall Number of Participants Analyzed 2 2 2 3 1
Mean (Full Range)
Unit of Measure: ratio
Post training
0.001
(0.001 to 0.001)
-0.078
(-0.101 to -0.055)
-0.045
(-0.057 to -0.033)
0.144
(-0.765 to 0.233)
-0.034
(-0.034 to -0.034)
Follow up
0.010
(0.007 to 0.013)
-0.075
(-0.091 to -0.058)
-0.124
(-0.221 to -0.028)
-0.096
(-0.412 to 0.125)
-0.027
(-0.027 to -0.027)
2.Secondary Outcome
Title Change in Baseline Oxygen Intake
Hide Description This is the change in metabolic power that is required of a subject to walk at their self selected walking speed on the treadmill. Metabolic power was measured at baseline, post training, and three months after training. We report the difference between post training and baseline and three months and baseline.
Time Frame Post training (week 14), and 3 months follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject in the Split-belt Severe Disability" Arm/Group did not complete the assessment during the change at follow up visit. Two subjects in the Tied-belt, Severe Disability Arm/Group were not able to complete the assessments at post training or follow up.
Arm/Group Title Split-belt, Mild Disability Split-belt, Moderate Disability Split-belt Severe Disability Tied-belt, Severe Disability Tied-belt Mild Disability
Hide Arm/Group Description:
Subjects trained on split belt treadmill. Subjects in the mild disability group had baseline walking speeds greater than 0.8 m/s. There were two subjects in this group.
Subjects trained on split belt treadmill. Subjects in the moderate disability group had baseline walking speeds of 0.4 m/s to 0.8 m/s. There were two subjects in this group.
Subjects trained on split belt treadmill. Subjects in the severe disability group had baseline walking speeds less than 0.4 m/s. There were two subjects in this group.
Subjects trained on tied belt treadmill. Subjects in the severe disability group had baseline walking speeds less than 0.4 m/s. There were three subjects in this group.
Subjects trained on tied belt treadmill. Subjects in the mild disability group had baseline walking speeds greater than 0.8 m/s. There was one subject in this group.
Overall Number of Participants Analyzed 2 2 2 3 1
Mean (Full Range)
Unit of Measure: ml/kg/min
Change at post training Number Analyzed 2 participants 2 participants 2 participants 1 participants 1 participants
0.82
(0.13 to 1.5)
-.61
(-.79 to -.43)
0.65
(-.59 to 1.89)
4.616 [1] 
(NA to NA)
-2.272 [2] 
(NA to NA)
Change at follow up Number Analyzed 2 participants 2 participants 1 participants 1 participants 1 participants
0.86
(0.26 to 1.46)
-0.84
(-0.9 to -0.79)
-0.85 [3] 
(-0.85 to NA)
4.009 [1] 
(NA to NA)
-2.675 [2] 
(NA to NA)
[1]
Two subjects were not able to complete this assessment.
[2]
There is only one subject in this group.
[3]
One subject was not able to complete this assessment.
3.Secondary Outcome
Title Walking Speed
Hide Description Subjects walked on an electronic walkway and walking speed was calculated by total distance divided by total time.
Time Frame Baseline, post training, and 3 month follow up.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects for whom walk speed was recorded at baseline, post training, and follow up.
Arm/Group Title Split-belt, Mild Disability Split-belt, Moderate Disability Split-belt Severe Disability Tied-belt, Severe Disability Tied-belt Mild Disability
Hide Arm/Group Description:
Subjects trained on split belt treadmill. Subjects in the mild disability group had baseline walking speeds greater than 0.8 m/s. There were two subjects in this group.
Subjects trained on split belt treadmill. Subjects in the moderate disability group had baseline walking speeds of 0.4 m/s to 0.8 m/s. There were two subjects in this group.
Subjects trained on split belt treadmill. Subjects in the severe disability group had baseline walking speeds less than 0.4 m/s. There were two subjects in this group.
Subjects trained on tied belt treadmill. Subjects in the severe disability group had baseline walking speeds less than 0.4 m/s. There were three subjects in this group.
Subjects trained on tied belt treadmill. Subjects in the mild disability group had baseline walking speeds greater than 0.8 m/s. There was one subject in this group
Overall Number of Participants Analyzed 2 2 2 3 1
Mean (Standard Deviation)
Unit of Measure: meters per second (m/s)
Baseline 1.22  (0) 0.5  (0.09) 0.11  (0.02) 0.12  (0.06) 1.08  (0)
Post training 1.17  (0.02) 0.55  (0.10) 0.16  (0.01) 0.18  (0.02) 1.10  (0)
Follow-up (3 months) 1.15  (0.02) 0.63  (0.26) 0.15  (0.02) 0.16  (0.05) 1.22  (0)
Time Frame 4 years, 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Split-belt Treadmill Exercise Tied-belt Treadmill Exercise
Hide Arm/Group Description

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 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.
All-Cause Mortality
Split-belt Treadmill Exercise Tied-belt Treadmill Exercise
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/4 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Split-belt Treadmill Exercise Tied-belt Treadmill Exercise
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Split-belt Treadmill Exercise Tied-belt Treadmill Exercise
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/4 (0.00%) 
Some subjects could not complete all of the tasks. Recruitment was also challenging.
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
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