An interventional study of Split belt treadmill in Stroke and Hemiparesis, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.. Completed at 1 site in United States. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-01-14.
Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether split belt or conventional treadmill training can be used to treat walking pattern deficits from stroke and to determine whether this improves gait asymmetry and metabolic efficiency.
Coordination between the legs during walking is often disrupted after neurological injury, resulting in asymmetric gait patterns. Recent data shows that walking patterns can be altered through treadmill training, even after central nervous system damage. The investigators have studied short-term adaptation of inter-limb coordination during walking using a split-belt treadmill to control speed of the two legs independently. Our findings demonstrate that walking patterns are adaptable. The investigators have also shown that people with cerebral damage from stroke can benefit in the short-term to correct asymmetric walking patterns. Since all of our previous work has focused on single training sessions or up to 4 week training sessions, the investigators would like to study long-term effects of split belt treadmill training. Therefore, the purpose of this study is to prepare for a clinical trial of split-belt treadmill training to treat walking pattern deficits from cerebral damage. The investigators will gather data to determine whether different types of treadmill training on a custom split-belt treadmill are likely to change/improve walking symmetry as well as metabolic efficiency.
The investigators will study adults with cerebral damage due to stroke. Subjects with hemiparesis will undergo training 3 times a week for a total of 33 training session. These 33 sessions will be broken into 3 blocks of 11 sessions. After each block of 11 sessions an evaluation will be done to record any gait improvements. Training for the subjects with hemiparesis will either be conventional treadmill walking (both legs moving at the same speed) or split-belt treadmill walking (with one leg moving faster than the other). These studies will provide important new information about normal mechanisms of locomotor adaptation, as well as providing a new rehabilitation tool for people with asymmetric gait patterns. Note that this study is not an aerobic conditioning program since subjects will work well below their age-adjusted target heart rate; it is instead a retraining program aimed at teaching people a new inter-limb coordination pattern as well as to determine whether this training can influence the subject's body's ability to use its intake of oxygen more efficiently. This study is also critical for developing procedural reliability processes, calculating effect sizes, training clinical staff, and determining other salient clinical variables in preparation for a randomized clinical trial.
7,287 studies on the registry are indexed under Stroke; 2,006 are open to participants now.
This study's enrollment of 34 is below the median of 50 across 5,370 interventional studies indexed under Stroke.
Browse Stroke studies →Hugo W. Moser Research Institute at Kennedy Krieger, Inc. is the lead sponsor of 76 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Split-belt treadmill exercise
Behavioral: 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.
Also known as: Woodway Split Belt Treadmill, Company: Woodway USA, Inc
Change in Baseline Step Length Symmetry. That is, Whether the Steps With Right and Left Legs Are the Same Length.
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
Change in Baseline Oxygen Intake
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
Walking Speed
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.
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.
| Milestone | Split-belt Treadmill Exercise | Tied-belt Treadmill Exercise |
|---|---|---|
| Started | 17 | 17 |
| Completed | 6 | 4 |
| Not completed | 11 | 13 |
| Withdrew: Baseline step length difference (<5cm) | 10 | 10 |
| Withdrew: Did not complete training | 0 | 2 |
| Withdrew: Investigator decision | 1 | 1 |
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.
| ratio | Split-belt, Mild Disability | Split-belt, Moderate Disability | Split-belt Severe Disability | Tied-belt, Severe Disability | Tied-belt Mild Disability |
|---|---|---|---|---|---|
| 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) |
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.
| ml/kg/min | Split-belt, Mild Disability | Split-belt, Moderate Disability | Split-belt Severe Disability | Tied-belt, Severe Disability | Tied-belt Mild Disability |
|---|---|---|---|---|---|
| Change at post training | 0.82 (0.13 to 1.5) | -.61 (-.79 to -.43) | 0.65 (-.59 to 1.89) | 4.616 (NA to NA) | -2.272 (NA to NA) |
| Change at follow up | 0.86 (0.26 to 1.46) | -0.84 (-0.9 to -0.79) | -0.85 (-0.85 to NA) | 4.009 (NA to NA) | -2.675 (NA to NA) |
Subjects walked on an electronic walkway and walking speed was calculated by total distance divided by total time.
| meters per second (m/s) | Split-belt, Mild Disability | Split-belt, Moderate Disability | Split-belt Severe Disability | Tied-belt, Severe Disability | Tied-belt Mild Disability |
|---|---|---|---|---|---|
| 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 |
Collected over 4 years, 9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Split-belt Treadmill Exercise | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Tied-belt Treadmill Exercise | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Continuous(years) | Split-belt Treadmill Exercise | Tied-belt Treadmill Exercise | Total |
|---|---|---|---|
| Mean | 60.8 ± 11.7 | 59.2 ± 14.3 | 60 ± 13 |
| Sex: Female, Male(Participants) | Split-belt Treadmill Exercise | Tied-belt Treadmill Exercise | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 6 | 3 | 9 |
| Ethnicity (NIH/OMB)(Participants) | Split-belt Treadmill Exercise | Tied-belt Treadmill Exercise | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 6 | 4 | 10 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Split-belt Treadmill Exercise | Tied-belt Treadmill Exercise | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 6 | 3 | 9 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Split-belt Treadmill Exercise | Tied-belt Treadmill Exercise | Total |
|---|---|---|---|
| United States | 6 | 4 | 10 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.