Trial Outcomes & Findings for Long Term Split Belt Treadmill Training for Stroke Recovery (NCT NCT01646216)
NCT ID: NCT01646216
Last Updated: 2019-01-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
After training (week 14), and 3 months after training
Results posted on
2019-01-14
Participant Flow
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.
Subjects were enrolled and randomly assigned to either Split or Tied treadmill training groups.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
11
|
13
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Baseline step length difference (<5cm)
|
10
|
10
|
|
Overall Study
Did not complete training
|
0
|
2
|
|
Overall Study
Investigator decision
|
1
|
1
|
Baseline Characteristics
Long Term Split Belt Treadmill Training for Stroke Recovery
Baseline characteristics by cohort
| Measure |
Split-belt Treadmill Exercise
n=6 Participants
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
n=4 Participants
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
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
59.2 years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
60 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After training (week 14), and 3 months after trainingPopulation: Subjects were grouped by baseline walking speed into three levels of disability: mild, moderate, and severe.
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.
Outcome measures
| Measure |
Split-belt, Mild Disability
n=2 Participants
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.
|
Split-belt, Moderate Disability
n=2 Participants
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.
|
Split-belt Severe Disability
n=2 Participants
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.
|
Tied-belt, Severe Disability
n=3 Participants
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.
|
Tied-belt Mild Disability
n=1 Participants
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.
|
|---|---|---|---|---|---|
|
Change in Baseline Step Length Symmetry. That is, Whether the Steps With Right and Left Legs Are the Same Length.
Post training
|
0.001 ratio
Interval 0.001 to 0.001
|
-0.078 ratio
Interval -0.101 to -0.055
|
-0.045 ratio
Interval -0.057 to -0.033
|
0.144 ratio
Interval -0.765 to 0.233
|
-0.034 ratio
Interval -0.034 to -0.034
|
|
Change in Baseline Step Length Symmetry. That is, Whether the Steps With Right and Left Legs Are the Same Length.
Follow up
|
0.010 ratio
Interval 0.007 to 0.013
|
-0.075 ratio
Interval -0.091 to -0.058
|
-0.124 ratio
Interval -0.221 to -0.028
|
-0.096 ratio
Interval -0.412 to 0.125
|
-0.027 ratio
Interval -0.027 to -0.027
|
SECONDARY outcome
Timeframe: Post training (week 14), and 3 months follow upPopulation: 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.
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.
Outcome measures
| Measure |
Split-belt, Mild Disability
n=2 Participants
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.
|
Split-belt, Moderate Disability
n=2 Participants
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.
|
Split-belt Severe Disability
n=2 Participants
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.
|
Tied-belt, Severe Disability
n=3 Participants
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.
|
Tied-belt Mild Disability
n=1 Participants
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.
|
|---|---|---|---|---|---|
|
Change in Baseline Oxygen Intake
Change at post training
|
0.82 ml/kg/min
Interval 0.13 to 1.5
|
-.61 ml/kg/min
Interval -0.79 to -0.43
|
0.65 ml/kg/min
Interval -0.59 to 1.89
|
4.616 ml/kg/min
Two subjects were not able to complete this assessment.
|
-2.272 ml/kg/min
There is only one subject in this group.
|
|
Change in Baseline Oxygen Intake
Change at follow up
|
0.86 ml/kg/min
Interval 0.26 to 1.46
|
-0.84 ml/kg/min
Interval -0.9 to -0.79
|
-0.85 ml/kg/min
Interval -0.85 to
One subject was not able to complete this assessment.
|
4.009 ml/kg/min
Two subjects were not able to complete this assessment.
|
-2.675 ml/kg/min
There is only one subject in this group.
|
SECONDARY outcome
Timeframe: Baseline, post training, and 3 month follow up.Population: All subjects for whom walk speed was recorded at baseline, post training, and follow up.
Subjects walked on an electronic walkway and walking speed was calculated by total distance divided by total time.
Outcome measures
| Measure |
Split-belt, Mild Disability
n=2 Participants
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.
|
Split-belt, Moderate Disability
n=2 Participants
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.
|
Split-belt Severe Disability
n=2 Participants
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.
|
Tied-belt, Severe Disability
n=3 Participants
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.
|
Tied-belt Mild Disability
n=1 Participants
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.
|
|---|---|---|---|---|---|
|
Walking Speed
Baseline
|
1.22 meters per second (m/s)
Standard Deviation 0
|
0.5 meters per second (m/s)
Standard Deviation 0.09
|
0.11 meters per second (m/s)
Standard Deviation 0.02
|
0.12 meters per second (m/s)
Standard Deviation 0.06
|
1.08 meters per second (m/s)
Standard Deviation 0
|
|
Walking Speed
Post training
|
1.17 meters per second (m/s)
Standard Deviation 0.02
|
0.55 meters per second (m/s)
Standard Deviation 0.10
|
0.16 meters per second (m/s)
Standard Deviation 0.01
|
0.18 meters per second (m/s)
Standard Deviation 0.02
|
1.10 meters per second (m/s)
Standard Deviation 0
|
|
Walking Speed
Follow-up (3 months)
|
1.15 meters per second (m/s)
Standard Deviation 0.02
|
0.63 meters per second (m/s)
Standard Deviation 0.26
|
0.15 meters per second (m/s)
Standard Deviation 0.02
|
0.16 meters per second (m/s)
Standard Deviation 0.05
|
1.22 meters per second (m/s)
Standard Deviation 0
|
Adverse Events
Split-belt Treadmill Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tied-belt Treadmill Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place