Hemiparesis, Stroke
Conditions
Keywords
stroke, treadmill, walking, hemiparesis, training
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSplit 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.
Sponsors
National Institutes of Health (NIH)
National Institute on Aging (NIA)
University of Maryland
VA Office of Research and Development
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Split belt treadmill
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* stroke or hemiparesis (\>6 months post stroke) * able to walk but has residual gait deficit (including those who walk with a cane or walker) * This is their first and only stroke * Able to walk for 5 minutes at their self-paced speed * Adults age 20-80
Exclusion criteria
* Cerebellar signs (e.g.ataxic hemiparesis) * Any neurologic condition other than stroke * Insulin dependent diabetes * Congestive heart failure * Peripheral artery disease with claudication * Pulmonary or renal failure * Unstable angina * Uncontrolled hypertension (\>190/110 mmHg) * Dementia * Severe aphasia * Orthopedic or pain conditions that limit walking * Total joint replacement in the lower extremities * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Baseline Step Length Symmetry. That is, Whether the Steps With Right and Left Legs Are the Same Length. | After training (week 14), and 3 months after training | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Baseline Oxygen Intake | Post training (week 14), and 3 months 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. |
| Walking Speed | Baseline, post training, and 3 month follow up. | Subjects walked on an electronic walkway and walking speed was calculated by total distance divided by total time. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| 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. | 4 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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
| Characteristic | Split-belt Treadmill Exercise | Total | Tied-belt Treadmill Exercise |
|---|---|---|---|
| Age, Continuous | 60.8 years STANDARD_DEVIATION 11.7 | 60 years STANDARD_DEVIATION 13 | 59.2 years STANDARD_DEVIATION 14.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 10 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 9 Participants | 3 Participants |
| Region of Enrollment United States | 6 participants | 10 participants | 4 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 6 Participants | 9 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 4 |
| other Total, other adverse events | 0 / 6 | 0 / 4 |
| serious Total, serious adverse events | 0 / 6 | 0 / 4 |
Outcome results
Primary
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
Population: Subjects were grouped by baseline walking speed into three levels of disability: mild, moderate, and severe.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Split-belt, Mild Disability | 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 |
| Split-belt, Mild Disability | 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 |
| Split-belt, Moderate Disability | Change in Baseline Step Length Symmetry. That is, Whether the Steps With Right and Left Legs Are the Same Length. | Post training | -0.078 ratio |
| Split-belt, Moderate Disability | Change in Baseline Step Length Symmetry. That is, Whether the Steps With Right and Left Legs Are the Same Length. | Follow up | -0.075 ratio |
| Split-belt Severe Disability | Change in Baseline Step Length Symmetry. That is, Whether the Steps With Right and Left Legs Are the Same Length. | Post training | -0.045 ratio |
| Split-belt Severe Disability | Change in Baseline Step Length Symmetry. That is, Whether the Steps With Right and Left Legs Are the Same Length. | Follow up | -0.124 ratio |
| Tied-belt, Severe Disability | Change in Baseline Step Length Symmetry. That is, Whether the Steps With Right and Left Legs Are the Same Length. | Follow up | -0.096 ratio |
| Tied-belt, Severe Disability | Change in Baseline Step Length Symmetry. That is, Whether the Steps With Right and Left Legs Are the Same Length. | Post training | 0.144 ratio |
| Tied-belt Mild Disability | Change in Baseline Step Length Symmetry. That is, Whether the Steps With Right and Left Legs Are the Same Length. | Post training | -0.034 ratio |
| Tied-belt Mild Disability | Change in Baseline Step Length Symmetry. That is, Whether the Steps With Right and Left Legs Are the Same Length. | Follow up | -0.027 ratio |
Secondary
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
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Split-belt, Mild Disability | Change in Baseline Oxygen Intake | Change at follow up | 0.86 ml/kg/min |
| Split-belt, Mild Disability | Change in Baseline Oxygen Intake | Change at post training | 0.82 ml/kg/min |
| Split-belt, Moderate Disability | Change in Baseline Oxygen Intake | Change at post training | -.61 ml/kg/min |
| Split-belt, Moderate Disability | Change in Baseline Oxygen Intake | Change at follow up | -0.84 ml/kg/min |
| Split-belt Severe Disability | Change in Baseline Oxygen Intake | Change at follow up | -0.85 ml/kg/min |
| Split-belt Severe Disability | Change in Baseline Oxygen Intake | Change at post training | 0.65 ml/kg/min |
| Tied-belt, Severe Disability | Change in Baseline Oxygen Intake | Change at post training | 4.616 ml/kg/min |
| Tied-belt, Severe Disability | Change in Baseline Oxygen Intake | Change at follow up | 4.009 ml/kg/min |
| Tied-belt Mild Disability | Change in Baseline Oxygen Intake | Change at follow up | -2.675 ml/kg/min |
| Tied-belt Mild Disability | Change in Baseline Oxygen Intake | Change at post training | -2.272 ml/kg/min |
Secondary
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.
Population: All subjects for whom walk speed was recorded at baseline, post training, and follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Split-belt, Mild Disability | Walking Speed | Baseline | 1.22 meters per second (m/s) | Standard Deviation 0 |
| Split-belt, Mild Disability | Walking Speed | Follow-up (3 months) | 1.15 meters per second (m/s) | Standard Deviation 0.02 |
| Split-belt, Mild Disability | Walking Speed | Post training | 1.17 meters per second (m/s) | Standard Deviation 0.02 |
| Split-belt, Moderate Disability | Walking Speed | Post training | 0.55 meters per second (m/s) | Standard Deviation 0.1 |
| Split-belt, Moderate Disability | Walking Speed | Baseline | 0.5 meters per second (m/s) | Standard Deviation 0.09 |
| Split-belt, Moderate Disability | Walking Speed | Follow-up (3 months) | 0.63 meters per second (m/s) | Standard Deviation 0.26 |
| Split-belt Severe Disability | Walking Speed | Post training | 0.16 meters per second (m/s) | Standard Deviation 0.01 |
| Split-belt Severe Disability | Walking Speed | Baseline | 0.11 meters per second (m/s) | Standard Deviation 0.02 |
| Split-belt Severe Disability | Walking Speed | Follow-up (3 months) | 0.15 meters per second (m/s) | Standard Deviation 0.02 |
| Tied-belt, Severe Disability | Walking Speed | Baseline | 0.12 meters per second (m/s) | Standard Deviation 0.06 |
| Tied-belt, Severe Disability | Walking Speed | Follow-up (3 months) | 0.16 meters per second (m/s) | Standard Deviation 0.05 |
| Tied-belt, Severe Disability | Walking Speed | Post training | 0.18 meters per second (m/s) | Standard Deviation 0.02 |
| Tied-belt Mild Disability | Walking Speed | Post training | 1.10 meters per second (m/s) | Standard Deviation 0 |
| Tied-belt Mild Disability | Walking Speed | Baseline | 1.08 meters per second (m/s) | Standard Deviation 0 |
| Tied-belt Mild Disability | Walking Speed | Follow-up (3 months) | 1.22 meters per second (m/s) | Standard Deviation 0 |