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| ID | Type | Description | Link |
|---|---|---|---|
| 2P30AG028747-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Aging (NIA) | NIH |
| University of Maryland | OTHER |
| VA Office of Research and Development |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Split-belt treadmill training | Experimental | Split-belt treadmill exercise |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Split belt treadmill | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After training (week 14), and 3 months after training |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post training (week 14), and 3 months follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy J Bastian, PhD, PT | Kennedy Krieger Institute and Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Motion Analysis Lab in the Kennedy Krieger Institute | Baltimore | Maryland | 21205 | United States |
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| Label | URL |
|---|---|
| Link Text: Motion Analysis Lab website at the Kennedy Krieger Institute | View source |
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Subjects were enrolled and randomly assigned to either Split or Tied treadmill training groups.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Subjects were grouped by baseline walking speed into three levels of disability: mild, moderate, and severe. | Posted | Mean | Full Range | ratio | After training (week 14), and 3 months after training |
|
4 years, 9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Some subjects could not complete all of the tasks. Recruitment was also challenging.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony Gonzalez | Kennedy Krieger Institute | 4439080074 | gonzalezan@kennedykrieger.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2013 | Nov 30, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| FED |
Split belt treadmill
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|
|
| Walking Speed | Subjects walked on an electronic walkway and walking speed was calculated by total distance divided by total time. | Baseline, post training, and 3 month follow up. |
| Investigator decision |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | 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. |
| OG002 | Split-belt Severe Disability | 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. |
| OG003 | Tied-belt, Severe Disability | 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. |
| OG004 | Tied-belt Mild Disability | 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. |
|
|
| 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. | 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. | Posted | Mean | Full Range | ml/kg/min | Post training (week 14), and 3 months follow up |
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|
|
| Secondary | Walking Speed | Subjects walked on an electronic walkway and walking speed was calculated by total distance divided by total time. | All subjects for whom walk speed was recorded at baseline, post training, and follow up. | Posted | Mean | Standard Deviation | meters per second (m/s) | Baseline, post training, and 3 month follow up. |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Change at follow up |
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| Post training |
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| Follow-up (3 months) |
|